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Anastomotic Leak

Overview and Recommendations

Background

● Anastomotic leak is a defect in the bowel wall at the anastomotic site, leading to leakage of intestinal
contents.
⚬ Severe, life-threatening complications of anastomotic leak may include:

– peritonitis
– sepsis, potentially resulting in organ failure
– local cancer recurrence in patients with surgery for colorectal cancer (cancer cells in resected
bowel may implant extraluminally via the leak)
⚬ Mortality is reported in about 0.5%-29% of patients who develop anastomotic leak.

● Incidence of anastomotic leaks varies by location and de nition, with a higher incidence occurring the
more distal the anastomosis is in colorectal surgeries.

● Patient-related risk factors include:

⚬ male sex
⚬ comorbidities, including:

– obesity
– poor nutrition
– diabetes mellitus
– hypoalbuminemia
– Crohn disease
– rectal cancer

⚬ American Society of Anesthesiologists (ASA) score III or IV


⚬ corticosteroid use
⚬ chemoradiation
⚬ use of nonselective nonsteroidal anti-in ammatory drugs (NSAIDs)

● Technical/procedural-related risk factors include:

⚬ more distal anastomosis


⚬ anastomosis performed under tension
⚬ straight coloanal anastomoses compared with colonic J-pouch anastomoses
⚬ ischemia at anastomotic site
⚬ surgery time > 2 hours
⚬ perioperative blood transfusion
⚬ emergency colorectal surgery
⚬ history of previous or revisional bariatric surgery
⚬ hand-sewn ileocolic anastomoses (compared to stapled ileocolic anastomoses)

Evaluation

● Intraoperative air-leak testing for assessment of anastomotic bowel integrity allows for quick
identi cation of leaks with the ability to reanastomose, divert fecal transit, or repair.

● Postoperative evaluation:
⚬ Up to 50% of patients are reported to be asymptomatic, with leaks detected incidentally on
imaging.
⚬ Diagnosis can be di cult, as clinical presentation varies widely and is usually nonspeci c. Findings
may include:
– abdominal pain, which can be severe
– fever
– nausea
– tachycardia
– tachypnea
– oliguria
– mental status changes
– feculent drainage or discharge

⚬ Blood test ndings may include leukocytosis and elevated C-reactive protein.
⚬ The diagnosis is typically con rmed by imaging studies (usually computed tomography with
contrast) showing a large collection of free uid, extravasation of contrast material, or a
perianastomotic uid collection.
⚬ Evaluation after bariatric surgery:

– consider assessing patients with respiratory distress or failure to wean from ventilation for a
postoperative anastomotic leak (Weak recommendation)
– consider computed tomography (preferred over upper gastrointestinal study) to evaluate
suspected anastomotic leaks in clinically stable patients (Weak recommendation)
– exploratory laparotomy or laparoscopy is recommended for highly suspected anastomotic leaks
(Strong recommendation)

Management

● Treatment is based on clinical presentation, which can vary from asymptomatic to emergent sepsis.

● Patients with severe sepsis who are hemodynamically unstable should be aggressively resuscitated,
followed by antibiotics and revision laparotomy to control the anastomotic leak.

● In stable, symptomatic patients without sepsis:

⚬ upper gastrointestinal anastomotic leaks can be managed by stopping oral intake and instituting
parenteral or jejunal nutritional support, broad-spectrum antibiotics, and percutaneous drainage
which is reported to resolve leaks in the majority of cases
⚬ colorectal anastomotic leaks can be managed by stopping oral intake and instituting parenteral
nutritional support, broad-spectrum antibiotics, and percutaneous drainage
⚬ more aggressive surgery may be necessary in patients with continuing leakage of enteric contents
or lack of clinical improvement following drainage

● Endoscopic therapies, including self-expanding metal or covered stents, clips, glue, or suturing (alone
or in combination), can be used for:
⚬ leaks refractory to 4 weeks of antibiotics and drainage
⚬ leaks presenting > 2-3 days after surgery or with signi cant peritoneal contamination (in
conjunction with antibiotics)
⚬ leaks that fail primary operative management

● Endoscopic vacuum therapy (EVT) can be used for:

⚬ acute and chronic anastomotic leaks < 5 cm


⚬ critically ill, hemodynamically unstable patients for infectious source control (if patient does not
respond to EVT therapy, surgery may still be required)

● Patients without symptoms may be managed expectantly with close surveillance.

Related Summaries

● Colorectal surgery considerations

● Bariatric Surgery in Adults

General Information

Description

● anastomotic leak is a defect in the bowel wall at the anastomotic site leading to leakage of intestinal
contents (World J Gastroenterol 2017 Sep 7;23(33):6172 full-text )

● comprehensive de nitions of an anastomotic leak utilize a combination of factors which may include

⚬ clinical indicators

– pain
– peritonitis
– feculent or purulent drainage

⚬ biochemical markers

– fever
– tachycardia
– leukocytosis

⚬ intraoperative ndings

– anastomotic disruption
– gross enteric leakage

⚬ radiologic indicators

– uid collections
– gas collections

⚬ Reference - World J Gastroenterol 2017 Sep 7;23(33):6172 full-text

American Society of Anesthesiologists (ASA) classification system

● American Society of Anesthesiologists (ASA) score has been validated to assess risk of postoperative
complications before any surgery
⚬ 1 - healthy, normal patient (for example, body mass index [BMI] < 30 kg/m2, nonsmoking, good
exercise tolerance)
⚬ 2 - patient with mild systemic disease or condition that is well-controlled and not associated with
functional limitations (for example, medication-controlled hypertension, obesity with BMI < 35
kg/m2, smoker, or frequent social drinker)
⚬ 3 - patient with severe disease that is not life-threatening (for example, poorly controlled diabetes
or hypertension, morbid obesity, stable angina, implanted pacemaker, chronic renal failure, or a
bronchospastic disease with occasional exacerbation)
⚬ 4 - patient with severe, life-threatening disease (for example, poorly controlled chronic obstructive
pulmonary disorder [COPD], symptomatic chronic heart failure, unstable angina, or myocardial
infarction or stroke within the last 3 months)
⚬ 5 - moribund patient not expected to survive > 24 hours without surgery (for example, massive
trauma, ruptured abdominal aortic aneurysm, or severe intracranial hemorrhage with mass e ect)
⚬ 6 - brain-dead patient whose organs are being removed in order to transplant them into another
patient
⚬ Reference - ASA Physical Status Classi cation System 2014 Oct 15

Types

● International Study Group of Rectal Cancer proposed grading system for anastomotic leak based on
clinical and imaging ndings
⚬ grade A - radiological or clinical exam ndings without associated symptoms or abnormal
laboratory tests which is managed expectantly
– clinical exam ndings may include seepage of new enteric content through drain or stula
(usually serous uid but may include turbid or fecal contents)
– usually detected by routine contrast enema studies before closure of a temporary
ileostomy/colostomy
⚬ grade B - leaks with signs and/or symptoms which requires nonoperative intervention including
antibiotics and/or image-guided drainage
– clinical presentation may include abdominal and/or pelvic pain, and possibly abdominal
distension and turbid/purulent rectal or vaginal discharge
– may have turbid/purulent or fecal drain contents depending on size of the leakage
– imaging studies (contrast enema x-ray or computed tomography [CT]) with transrectal
instillation of contrast may show leakage of the endoluminally administered contrast agent into
the extraintestinal space, and potentially pelvic uid collection (abscess)
⚬ grade C - leak which requires revision laparotomy to control life-threatening sepsis, including either
removal of anastomosis with end colostomy, or creation of a protective ileostomy
– clinical presentation typically includes purulent/fecal drainage, severe abdominal pain, fever,
signs of peritonitis (rebound tenderness, abdominal wall rigidity, and tachycardia), in addition to
notably elevated C-reactive protein and leukocytosis
– imaging studies, such as CT with transrectal contrast instillation, typically show leakage at the
anastomotic site and pelvic uid collection
⚬ Reference - Surgery 2010 Mar;147(3):339

● anastomotic leaks can also be classi ed chronologically from the time of surgery 3

⚬ early - developing < 3 days after surgery


⚬ intermediate - developing 4-7 days after surgery
⚬ late - developing ≥ 8 days after surgery

Epidemiology

Incidence/Prevalence

● incidence of anastomotic leaks varies by location and de nition, with a higher incidence occurring the

more distal the anastomosis in colorectal surgeries 1 , 2 , 3


● reported leak rates by site of anastomosis 1

⚬ 0.5%-6% with ileocolic anastomoses


⚬ 0%-9% with colocolonic anastomoses
⚬ 0%-20% with colorectal anastomoses

● reported leak rates with rectal anastomosis 3

⚬ 1.7% with high rectal anastomoses


⚬ 4.1% with low rectal anastomoses
⚬ 7.3% with ultra-low rectal anastomoses

● following Roux-en-Y gastric bypass surgery

⚬ 2%-5% of patients reported to develop anastomotic leak 3

⚬ reported incidence by location

– 67.8% gastrojejunostomy
– 5% jejunojejunal anastomosis
– Reference - Arq Bras Cir Dig 2015;28(1):74 full-text

Risk factors

● patient-related risk factors

⚬ male sex 1

⚬ obesity 1

⚬ poor nutrition 3

⚬ diabetes mellitus 2

⚬ hypoalbuminemia 1

⚬ American Society of Anesthesiologist (ASA) score III or IV (compared to ASA I or II) 1

⚬ Crohn disease 1

⚬ rectal cancer (Patient Saf Surg 2010 Mar 25;4(1):5 full-text )


⚬ corticosteroid use 1

⚬ chemoradiation (World J Gastroenterol 2016 Jul 7;22(25):5718 full-text )


⚬ nonselective nonsteroidal anti-in ammatory drug (NSAID) use 1

STUDY
– SUMMARY
postoperative use of nonsteroidal anti-inflammatory drugs, particularly diclofenac,
associated with increased risk for anastomotic leak following colorectal surgery

SYSTEMATIC REVIEW: Surg Endosc 2019 Mar;33(3):879

Details
● based on systematic review of observational studies
● systematic review of 7 studies (6 retrospective cohorts, 1 case-control) evaluating
postoperative NSAID use in 9,835 adults following colorectal surgery
⚬ 5 studies evaluated nonselective NSAIDs
⚬ 1 study evaluated both selective and nonselective NSAIDs
⚬ 1 study did not specify if NSAIDs were selective or nonselective
● compared to controls without NSAID use, increased risk for anastomotic leak with
postoperative NSAID use (odds ratio [OR] 1.58, 95% CI 1.23-2.03) in analysis of 7 studies with
9,835 patients
● no signi cant di erences in risk for anastomotic leak with use of the NSAID ketorolac
(nonselective) in subgroup analysis of 2 studies with 988 patients
● Reference - Surg Endosc 2019 Mar;33(3):879

● technical/procedural-related risk factors

⚬ more distal anastomosis 2

⚬ anastomosis performed under tension 2

⚬ straight coloanal anastomoses compared to colonic J-pouch anastomoses 1

⚬ ischemia at site of anastomosis 1 , 3

⚬ surgery time > 2 hours (J Am Coll Surg 2009 Feb;208(2):269 ), commentary can be found in J Am
Coll Surg 2009 Jun;208(6):1152
⚬ perioperative blood transfusion (J Am Coll Surg 2009 Feb;208(2):269 ), commentary can be found
in J Am Coll Surg 2009 Jun;208(6):1152
⚬ emergency colorectal surgery (Patient Saf Surg 2010 Mar 25;4(1):5 full-text )
⚬ history of previous or revisional bariatric surgery (Arq Bras Cir Dig 2015;28(1):74 full-text )
⚬ hand-sewn ileocolic anastomoses (compared to stapled ileocolic anastomoses) 1

STUDY
– SUMMARY
stapled ileocolic anastomosis associated with fewer leaks than hand-sewn ileocolic
anastomosis DynaMed Level 2

COCHRANE REVIEW: Cochrane Database Syst Rev 2011 Sep 7;(9):CD004320

Details
● based on Cochrane review of trials with methodologic limitations
● systematic review of 7 randomized trials comparing linear cutter stapling (isoperistaltic side-
to-side or functional end-to-end) to hand-sewn techniques in 1,125 adults requiring ileocolic
anastomosis
● 6 trials did not report intention-to-treat analyses, 1 additional trial did not have blinded
outcome assessment
● comparing stapled vs. hand-sewn ileocolic anastomosis

⚬ stapled anastomosis associated with fewer anastomotic leaks

– in overall analysis of 7 trials

– odds ratio (OR) 0.48 (95% CI 0.24-0.95)


– NNT 23-354 with leakage in 6% of hand-sewn group

– in subgroup analysis of 825 cancer patients from 4 trials

– OR 0.28 (95% CI 0.1-0.75)


– NNT 16-61 with leakage in 7% of hand-sewn group

⚬ no signi cant di erences between groups in

– anastomotic leakage in subgroup analysis of 264 noncancer patients from 3 trials


– stricture, anastomotic hemorrhage, anastomotic time, reoperation, mortality, intra-
abdominal abscess, wound infection, or length of stay
● Reference - Cochrane Database Syst Rev 2011 Sep 7;(9):CD004320

STUDY
⚬ SUMMARY
open surgery and conversion to open surgery may each increase risk of 30-day anastomotic
leak compared to laparoscopic surgery in patients having colectomy for colon cancer
DynaMed Level 2

COHORT STUDY: World J Surg 2017 Aug;41(8):2143

Details
– based on retrospective cohort study
– 25,097 patients (mean age 66 years) having elective partial or total colectomy with or without
proximal diverting ostomy for colon cancer were strati ed by operative approach
● 30.5% of patients had laparoscopic surgery without conversion to open surgery
● 30.5% of patients had hand-assisted surgery de ned as any minimally-invasive technique
with hand or open assist (including laparoscopic, robotic, hybrid, or other) without
conversion to open surgery
● 26.7% of patients had planned open surgery
● 8% of patients had conversion to open surgery from a minimally-invasive approach
● 4.2% of patients had robotic surgery (excluding those with hand- or open-assist) without
conversion to open surgery
– 3.32% of patients developed anastomotic leak within 30 days of surgery
– factors associated with increased risk for anastomotic leak compared to laparoscopic surgery

● open surgery (adjusted odds ratio [OR] 1.72, 95% CI 1.42-2.1)


● conversion to open surgery (adjusted OR 1.81, 95% CI 1.39-2.36)
● hand-assisted surgery (adjusted OR 1.3, 95% CI 1.06-1.59)

– no signi cant di erence in risk of anastomotic leakage comparing robotic surgery to


laparoscopic surgery
– Reference - World J Surg 2017 Aug;41(8):2143

Factors not associated with increased risk

● immunomodulator use, such as

⚬ azathioprine 1 , 2

⚬ 6-mercaptopurine 2

● single-layer compared to double-layer hand-sewn colorectal anastomoses 1

STUDY
⚬ SUMMARY
single-layer suture anastomosis may shorten operating time without increasing risk for
postoperative leak or complications compared to double-layer anastomosis DynaMed Level 2

COCHRANE REVIEW: Cochrane Database Syst Rev 2012 Jan 18;(1):CD005477

Details
– based on Cochrane review of trials with methodologic limitations
– systematic review of 7 randomized trials comparing single-layer to double-layer suture
anastomosis in 842 patients having gastrointestinal surgery
– most trials did not report allocation concealment or blinding of outcome assessor; authors
presented con icting information on these quality measures for 1 trial
– no signi cant di erences between groups in

● anastomotic leak in analysis of 7 trials with 842 patients


● major complications in analysis of 7 trials with 842 patients
● mortality in analysis of 4 trials with 403 patients
● length of hospital stay in analysis of 3 trials with 390 patients

– single layer suture anastomosis associated with reduced operating time (mean di erence -11.12
minutes, 95% CI -16.37 to -5.87 minutes) in analysis of 2 trials with 218 patients
– Reference - Cochrane Database Syst Rev 2012 Jan 18;(1):CD005477

Etiology and Pathogenesis

● pathogenesis of anastomotic leak is unknown (BMC Gastroenterol 2015 Dec 21;15:180 full-text )

● early leaks after bariatric surgery are usually attributed to a technical/procedural factor, while leaks

occurring ≥ 4 days postoperatively may be due to ischemia or patient-related factors 3

Clinical Presentation

● up to 50% of patients are reported to be asymptomatic, with leaks detected incidentally on imaging 3

● signs and symptoms, if present, usually develop 5-8 days postoperatively, and may include 1

⚬ abdominal pain, which can be severe 1 , 2 , 3

⚬ fever 1 , 2

⚬ nausea 1

⚬ tachycardia 1 , 2 , 3

⚬ tachypnea 2

⚬ oliguria 2

⚬ mental status changes 2

⚬ feculent drainage or discharge 1

● acute, self-limited leaks or slow leaks may present as chronic stulas, with symptoms arising months

to years after surgery 3


⚬ presentation may include pain or general feeling of malaise
⚬ in patients with a history of bariatric surgery, stulas that develop between the gastric pouch and
gastric remnant may result in weight regain

● most common signs and symptoms in retrospective cohort of 58 patients with anastomotic leak
presenting at mean 8 days (range 3-65 days) postoperatively
⚬ nonspeci c ndings (such as low-grade fever, mild tachycardia, and leukocytosis) in 80%
⚬ abdominal pain in 64%
⚬ fever in 52%
⚬ nausea in 24%
⚬ frank peritonitis in 22%
⚬ Reference - Arch Surg 2009 Apr;144(4):333

● American Association of Clinical Endocrinologists/American College of Endocrinology/Obesity


Society/American Society for Metabolic and Bariatric Surgery/Obesity Medicine Association/American
Society of Anesthesiologists (AACE/ACE/OS/ASMBS/OMA/ASA) recommendations for assessment of
postoperative anastomotic leak
⚬ signs of possible anastomotic leak include sustained resting tachycardia, hypoxia, and fever
⚬ consider assessing patients with respiratory distress or failure to wean from ventilation after
bariatric surgery for postoperative anastomotic leak (AACE/ACE/OS/ASMBS/OMA/ASA Grade D)
⚬ consider computed tomography (CT) (preferred over upper-GI studies [water-soluble contrast
followed by thin barium]) to evaluate for anastomotic leaks in suspected patients
(AACE/ACE/OS/ASMBS/OMA/ASA Grade C, BEL 3)
⚬ consider selected diatrizoate meglumine and diatrizoate sodium upper-GI study in the absence of
abnormal signs or symptoms to identify any subclinical leaks before discharge, however, routine
use is not recommended (AACE/ACE/OS/ASMBS/OMA/ASA Grade C, BEL 3)
⚬ consider C-reactive protein test if postoperative leak suspected after hospital discharge
(AACE/ACE/OS/ASMBS/OMA/ASA Grade B, BEL 2)
⚬ exploratory laparotomy or laparoscopy is reommended for highly suspected anastomotic leaks
(AACE/ACE/OS/ASMBS/OMA/ASA Grade A, BEL 1)
⚬ Reference - AACE/ACE/OS/ASMBS/OMA/ASA clinical practice guidelines for the for the perioperative
nutritional, metabolic, and nonsurgical support of the bariatric surgery patient--2019 update
(Obesity (Silver Spring) 2020 Apr;28(4):O1 )

Diagnosis

Making the diagnosis

● diagnosis can be di cult, as clinical presentation varies widely and is usually nonspeci c 2

● suspect the diagnosis in patients who have undergone intestinal anastomosis who have postoperative
abdominal pain, fever, nausea, tachycardia, hyperthermia, tachypnea, oliguria, or mental status
changes 1 , 2 , 3

● the diagnosis is typically con rmed by imaging studies , usually computed tomography with contrast,
showing a large collection of free uid, extravasation of contrast material, or a perianastomotic uid
collection 2

Testing overview

● computed tomography (CT) scan with oral and/or rectal contrast or a contrast enema is commonly
used to con rm diagnosis of anastomotic leak and can assist with management planning

● for upper gastrointestinal anastomotic sites, imaging studies such as contrast esophagrams and
upper gastrointestinal x-ray series have been used, but are reported to have limited sensitivity

● blood test ndings associated with anastomotic leak include

⚬ elevated C-reactive protein (CRP)


⚬ elevated white blood cell count

● analysis of biomarkers for ischemia in drain uid may aid early diagnosis of anastomotic bowel leak
Clinical prediction rules

STUDY
● SUMMARY
modified Dutch leakage (DULK) score appears at least as effective as original DULK score, and
associated with high sensitivity for clinically relevant anastomotic leak following colorectal
surgery DynaMed Level 2

COHORT STUDY: Colorectal Dis 2013 Sep;15(9):e528

Details
⚬ based on retrospective prognostic cohort study
⚬ 782 patients with an anastomosis in the colon or rectum between October 2007 and November
2009 from 5 Dutch centers were evaluated by the original and modi ed DULK score
– modi ed DULK score based on 4 parameters with a score of ≥ 1 considered positive for
anastomotic leak
● respiratory rate ≥ 20/minute (1 point)
● deteriorating clinical condition (1 point)
● abdominal pain other than wound pain (1 point)
● C-reactive protein (CRP) > 250 (1 point)

– original DULK score based on 13 parameters with a score of ≥ 4 considered positive for
anastomotic leak
● fever > 38 degrees C (100.4 degrees F) (1 point)
● heart rate > 100/minute (1 point)
● respiratory rate > 30/minute (1 point)
● urinary production < 30 mL/hour or 700 mL/day (1 point)
● agitation or lethargic mental status (2 points)
● deteriorating clinical condition (2 points)
● presence of

⚬ bowel obstruction (2 points)


⚬ gastric retention (2 points)
⚬ fascial dehiscence (2 points)
⚬ abdominal pain other than wound pain (2 points)

● increase of ≥ 5% in leukocyte number or CRP (1 point)


● increase of ≥ 5% in urea or creatinine (1 point)
● nutritional status

⚬ tube feeding (1 point)


⚬ total parenteral nutrition (2 points)

⚬ reference standard was clinically apparent leakage (such as fecal discharge from drains or
abdominal wound) or radiological, endoscopic, or surgically proven leakage
⚬ 10.4% of patients had clinically relevant anastomotic leak per reference standard
⚬ diagnostic performance of modi ed DULK score with cuto ≥ 1 point for detection of clinically
relevant anastomotic leak
– sensitivity 97%
– speci city 56.8%
– positive predictive value 17.2%
– negative predictive value 99.5%
⚬ diagnostic performance of original DULK score with cuto ≥ 4 points for detection of clinically
relevant anastomotic leak
– sensitivity 97%
– speci city 53.6%
– positive predictive value 16.2%
– negative predictive value 99.5%

⚬ Reference - Colorectal Dis 2013 Sep;15(9):e528

Intraoperative leak testing

● intraoperative air-leak testing for assessment of anastomotic bowel integrity allows for quick

identi cation of leaks with ability to reanastomose, divert fecal transit, or repair 2
⚬ air-leak testing is usually performed by lling pelvis with saline, occluding proximal bowel, and

introducing air transanally using a syringe, bulb, or exible endoscope 2


– reported to identify leaks in up to 25% of anastomoses
– not all positive air-leak tests will result in clinically-detected or radiographically-visible
anastomotic leaks
⚬ injection of methylene blue through orogastric tube is another method used for air-leak testing
(Arq Bras Cir Dig 2015;28(1):74 full-text )

● techniques for intraoperative leak testing which have not shown su cient e cacy to be widely
accepted include
⚬ Doppler owmetry
⚬ scanning laser owmetry
⚬ uorescence videography
⚬ near-infrared spectroscopy
⚬ intramucosal pH measurements
⚬ intraoperative colonoscopy
⚬ intraoperative visible light spectroscopy
⚬ Reference - Anticancer Res 2010 Feb;30(2):601

STUDY
● SUMMARY
intraoperative endoscopic air-leak testing may reduce postoperative anastomotic leaks
compared to intraoperative visual inspection in patients having laparoscopic Roux-en-Y gastric
bypass DynaMed Level 2

RANDOMIZED TRIAL: Int J Surg 2018 Feb;50:17

Details
⚬ based on randomized trial without allocation concealment
⚬ 100 patients having laparoscopic Roux-en-Y gastric bypass randomized to intraoperative air-leak
testing vs. intraoperative visual inspection and followed for 30 days
⚬ 4 leaks were found in intraoperative endoscopic air-leak testing group and repaired
intraoperatively
⚬ comparing intraoperative endoscopic air leak testing vs. visual inspection

– postoperative gastrojejunal anastomotic leak in 0% vs. 8% (p = 0.04)


– need for reoperation in 0% vs. 8% (p = 0.04)
– mean duration of surgery 194 minutes vs. 159 minutes (p < 0.001)
– mean length of hospital stay of 2.44 days vs. 3.46 days (p = 0.025)

⚬ no signi cant di erences in rate of bleeding of gastrojejunal anastomosis, narrow gastrojejunal


anastomosis, or 30-day mortality
⚬ Reference - Int J Surg 2018 Feb;50:17

STUDY
● SUMMARY
intraoperative air-leak testing of left-sided colorectal anastomoses may be associated with
reduced incidence of clinical leaks DynaMed Level 2

COHORT STUDY: Arch Surg 2009 May;144(5):407

Details
⚬ based on retrospective cohort study
⚬ 998 left-sided colorectal anastomoses analyzed from prospective database
⚬ of 825 anastomoses with air-leak testing, 7.9% had intraoperative air leaks
⚬ incidence of clinical leaks (p < 0.03 among groups)

– 3.8% anastomoses with negative air-leak test results


– 7.7% anastomoses with positive air-leak test results
– 8.1% untested anastomoses

⚬ Reference - Arch Surg 2009 May;144(5):407

STUDY
● SUMMARY
intraoperative methylene blue enema following colonic anastomosis reported to detect
intraoperative leak DynaMed Level 3

CASE SERIES: BMC Surg 2007 Aug 2;7:15 | Full Text

Details
⚬ based on case series
⚬ 229 surgeries with colonic anastomosis and intraoperative methylene blue enema were evaluated
⚬ intraoperative leak detected in 7% anastomoses (4.5% proximal and 8% distal anastomoses)
⚬ postoperative leak rate 3%
⚬ no cases of postoperative leak reported in patients who had intraoperative repair following
detection of intraoperative leak
⚬ Reference - BMC Surg 2007 Aug 2;7:15 full-text

Blood tests

● blood test ndings associated with anastomotic leak include 1 , 2

⚬ increasing C-reactive protein (CRP) (may be > 250 mg/L)


⚬ elevated white blood cell counts

STUDY
● SUMMARY
normal serum C-reactive protein on postoperative day 3-5 may help identify patients at low risk
of anastomotic leak after colorectal surgery DynaMed Level 2

SYSTEMATIC REVIEW: Br J Surg 2014 Mar;101(4):339

Details
⚬ based on systematic review limited by clinical heterogeneity
⚬ systematic review of 7 cohort studies evaluating serum C-reactive protein for predicting
anastomotic leakage in 2,483 patients who had colorectal surgery
⚬ de nitions of anastomotic leak and reference standards for anastomotic leak varied across studies
⚬ pooled prevalence of anastomotic leakage 9.6%
⚬ pooled performance of serum C-reactive protein for predicting anastomotic leak

– on postoperative day 3 with cuto of 172 mg/L in analysis of 5 studies with 2,126 patients
● sensitivity 76% (95% CI 66%-84%)
● speci city 76% (95% CI 67%-83%)
● negative predictive value 97%

– similar performance found on postoperative day 4 with cuto of 124 mg/L and on postoperative
day 5 with cuto of 144 mg/L
⚬ Reference - Br J Surg 2014 Mar;101(4):339

Imaging studies

● computed tomography (CT) scan with oral and/or rectal contrast or a contrast enema is commonly
used to con rm diagnosis of colorectal anastomotic leak, and can assist with management
planning 1 , 2

STUDY
⚬ SUMMARY
multidirectional CT may help confirm anastomotic leak in patients having left-sided colonic
anastomoses with circular stapling DynaMed Level 2

DIAGNOSTIC COHORT STUDY: Clin Radiol 2014 Jan;69(1):59

Details
– based on retrospective diagnostic cohort study
– 170 patients having left-sided colonic anastomoses with circular stapling were evaluated
– anastomotic leak suspected in 17.6% (30 patients) postoperatively

● 28 patients had multidirectional CT scan enhanced (IV contrast) or unenhanced with addition
of rectal contrast
● 2 patients had immediate surgery

– reference standard was surgery and clinical outcome


– 7.6% of patients had anastomotic leak by reference standard, with 20% related mortality
– diagnostic performance of multidirectional CT scan for detection of clinically suspected
anastomotic leak
● sensitivity 91%
● speci city 100%
● positive predictive value 100%
● negative predictive value 95%

– diagnostic performance of individual signs on multidirectional CT

● extravasation of rectal contrast

⚬ sensitivity 100%
⚬ speci city 100%

● presence of peri-anastomotic free air

⚬ sensitivity 81%
⚬ speci city 74%

● presence of peri-anastomotic uid collections

⚬ sensitivity 63%
⚬ speci city 88%

● staple line integrity

⚬ sensitivity 72%
⚬ speci city not applicable

– Reference - Clin Radiol 2014 Jan;69(1):59

● CT scan with oral, water-soluble contrast provides very high sensitivity for detection of anastomotic

leaks after bariatric surgery 3


⚬ other imaging studies, including contrast esophagrams and upper gastrointestinal x-ray series,

have been used but are reported to have limited sensitivity 3

STUDY
– SUMMARY
selective upper gastrointestinal series appears to have higher sensitivity and similar
specificity as routine upper gastrointestinal series for detecting anastomotic leaks in
patients with laparoscopic Roux-en-Y gastric bypass DynaMed Level 2

DIAGNOSTIC COHORT STUDY: Obes Surg 2011 Aug;21(8):1238

Details
● based on retrospective diagnostic cohort study without blinding
● 804 patients (mean age 41 years) having laparoscopic Roux-en-Y gastric bypass were
assessed with selective or routine gastrointestinal series
⚬ 52.5% of patients had selective upper gastrointestinal series (performed if tachycardia,
fever, drainage content, or general condition was suspicious for gastrojejunostomy leak)
from May 2005 to April 2010
⚬ 47.5% of patients had routine upper gastrointestinal series from June 2000 to April 2005

● reference standard was operative or clinical ndings


● 1.1% of patients had anastomotic leak per reference standard
● diagnostic performance of selective upper gastrointestinal series for detection of
anastomotic leak
⚬ sensitivity 80%
⚬ speci city 91%
⚬ positive predictive value 80%
⚬ negative predictive value 91%

● diagnostic performance of routine upper gastrointestinal series for detection of anastomotic


leak
⚬ sensitivity 50%
⚬ speci city 97%
⚬ positive predictive value 18%
⚬ negative predictive value 99%

● no signi cant di erences between groups in

⚬ time to diagnosis
⚬ overall leak rate
● Reference - Obes Surg 2011 Aug;21(8):1238

Drain fluid assessment

● analysis of biomarkers of ischemia in drain uid may aid early diagnosis of anastomotic bowel leak 1

⚬ markers of ischemia associated with bowel leak include

– pH < 7 (Asian Pac J Cancer Prev 2013;14(9):5441 full-text )


– increased lactate/pyruvate ratio (Scand J Gastroenterol 2011 Jul;46(7-8):913 )

STUDY
● SUMMARY
elevated lactate and pH levels < 7 in peritoneal drain fluid might each be associated with
colorectal anastomotic leaks DynaMed Level 2

SYSTEMATIC REVIEW: Int J Colorectal Dis 2017 Jul;32(7):935

Details
⚬ based on systematic review of diagnostic studies limited by clinical heterogeneity
⚬ systematic review of 13 prospective diagnostic studies evaluating the ability of peritoneal uid
biomarkers to identify early colorectal anastomotic leaks
– 7 studies evaluated biomarkers of ischemia (5 studies evaluated lactate, 2 studies evaluated pH)
in 1,088 patients
– 7 studies evaluated biomarkers of in ammation (cytokines) in 322 patients

⚬ meta-analysis not performed due to clinical heterogeneity, including di erences in patient


populations, end points analyzed, and de nitions of anastomotic leaks
⚬ ischemic biomarkers consistently showing associations with anastomotic leaks include

– elevated lactate in 5 studies with 245 patients


– pH < 7 in 2 studies with 843 patients

⚬ elevated in ammatory biomarkers (interleukin 6 and tumor necrosis factor-alpha) showed


con icting associations with anastomotic leaks in 7 studies with 322 patients
⚬ Reference - Int J Colorectal Dis 2017 Jul;32(7):935

Treatment

Treatment overview

● management is based on clinical presentation which can vary from asymptomatic to emergent

sepsis 2
⚬ patients with severe sepsis who are hemodynamically unstable should be aggressively

resuscitated, followed by antibiotics and revision laparotomy to control the anastomotic leak 3
⚬ in stable, symptomatic patients without sepsis

– upper gastrointestinal anastomotic leaks can be managed by stopping oral intake and
instituting parenteral or jejunal nutritional support, broad-spectrum antibiotics, and
percutaneous drainage, which is reported to resolve leaks in majority of patients 3
– colorectal anastomotic leaks can be managed by stopping oral intake and instituting parenteral

nutritional support, broad-spectrum antibiotics, and percutaneous drainage 2


– more aggressive surgery may be necessary in patients with continuing leakage of enteric

contents or lack of clinical improvement following drainage 2


⚬ endoscopic therapies using self-expanding metal or covered stents, clips, glue, or suturing (alone

or in combination), can be used for 2 , 3


– leaks that fail primary operative management
– leaks refractory to 4 weeks of antibiotics and drainage
– leaks presenting > 2-3 days after surgery or with signi cant peritoneal contamination (in
conjunction with antibiotics)
⚬ endoscopic vacuum therapy can be used for

– acute and chronic anastomotic leaks < 5 cm


– critically ill, hemodynamically unstable patients for infectious source control (if patient does not
respond to EVT therapy, surgery may still be required)
⚬ patients without symptoms may be managed expectantly with close surveillance so that immediate
action can be taken for sudden exacerbations (J Visc Surg 2014 Dec;151(6):441 )

● management strategy based on the International Study Group of Rectal Cancer proposed grading
system for anastomotic leaks
⚬ grade A leaks (radiological or clinical exam ndings without associated symptoms or abnormal
laboratory tests) are usually managed expectantly, but may require delay in ileostomy/colostomy
closure
⚬ grade B leaks (radiological or clinical exam ndings with associated symptoms or abnormal
laboratory tests) can be managed nonoperatively with antibiotics and/or drainage using pelvic
drain or transanal lavage
⚬ grade C leaks require revision laparotomy for control of life-threatening sepsis, including either
removal of anastomosis with end colostomy, or creation of a protective ileostomy
⚬ Reference - Surgery 2010 Mar;147(3):339

Antibiotics

● in symptomatic patients who are stable, antibiotics are rst-line treatment and may be used alone or

in combination with percutaneous drainage or surgery based on severity of leak 2

● gram-negative and anaerobic coverage may be used for small abscesses not requiring percutaneous

drainage 2

● Surgical Infection Society and the Infectious Diseases Society of America (SIS/IDSA) recommended
options for empiric IV antibiotics for adults with complicated intra-abdominal infection include
(SIS/IDSA Grade B, Level II)
⚬ piperacillin-tazobactam 3.375 g every 6 hours
⚬ ticarcillin-clavulanate 3.1 g every 6 hours
⚬ doripenem 500 mg every 8 hours
⚬ ertapenem 1 g every 24 hours
⚬ imipenem-cilastatin 500 mg every 6 hours or 1 g every 8 hours
⚬ meropenem 1 g every 8 hours
⚬ cefazolin 1-2 g every 8 hours
⚬ cefepime 2 g every 8-12 hours
⚬ cefotaxime 1-2 g every 6-8 hours
⚬ cefoxitin 2 g every 6 hours
⚬ ceftazidime 2 g every 8 hours
⚬ ceftriaxone 1-2 g every 12-24 hours
⚬ cefuroxime 1.5 g every 8 hours
⚬ tigecycline 100-mg initial dose, then 50 mg every 12 hours
⚬ cipro oxacin 400 mg every 12 hours
⚬ levo oxacin 750 mg every 24 hours
⚬ moxi oxacin 400 mg every 24 hours
⚬ metronidazole 500 mg every 8-12 hours or 1,500 mg every 24 hours
⚬ gentamicin or tobramycin 5-7 mg/kg every 24 hours
⚬ amikacin 15-20 mg/kg every 24 hours
⚬ aztreonam 1-2 g every 6-8 hours
⚬ vancomycin 15-20 mg/kg every 8-12 hours
⚬ Reference - SIS/IDSA guidelines on diagnosis and management of complicated intra-abdominal
Infection in adults and children (Clin Infect Dis 2010 Jan 15;50(2):133 full-text ), correction can
be found in Clin Infect Dis 2010 Jun 15;50(12):1695, commentary can be found in Clin Infect Dis
2010 Sep 15;51(6):757

● SIS/IDSA recommended options for empiric IV antibiotics for children with complicated intra-
abdominal infection include
⚬ amikacin 15-22.5 mg/kg/day every 8-24 hours
⚬ ampicillin sodium 200 mg/kg/day every 6 hours
⚬ ampicillin/sulbactam 200 mg/kg/day of ampicillin component every 6 hours
⚬ aztreonam 90-120 mg/kg/day every 6-8 hours
⚬ cefepime 100 mg/kg/day every 12 hours
⚬ cefotaxime 150-200 mg/kg/day every 6-8 hours
⚬ cefotetan 40-80 mg/kg/day every 12 hours
⚬ cefoxitin 160 mg/kg/day every 4-6 hours
⚬ ceftazidime 150 mg/kg/day every 8 hours
⚬ ceftriaxone 50-75 mg/kg/day every 12-24 hours
⚬ cefuroxime 150 mg/kg/day every 6-8 hours
⚬ cipro oxacin 20-30 mg/kg/day every 12 hours
⚬ clindamycin 20-40 mg/kg/day every 6-8 hours
⚬ ertapenem

– 3 months to 12 years: 15 mg/kg twice daily (not to exceed 1 g/day) every 12 hours
– ≥ 13 years: 1 g/day every 24 hours

⚬ gentamicin 3-7.5 mg/kg/day every 2-4 hours


⚬ imipenem/cilastatin 60-100 mg/kg/day every 6 hours
⚬ meropenem 60 mg/kg/day every 8 hours
⚬ metronidazole 30-40 mg/kg/day every 8 hours
⚬ piperacillin/tazobactam 200-300 mg/kg/day of piperacillin component every 6-8 hours
⚬ ticarcillin/clavulanate 200-300 mg/kg/day of ticarcillin component every 4-6 hours
⚬ tobramycin 3.0-7.5 mg/kg/day every 8-24 hours
⚬ vancomycin 40 mg/kg/day as 1 h infusion every 6-8 hours
⚬ Reference - SIS/IDSA guidelines on diagnosis and management of complicated intra-abdominal
Infection in adults and children (Clin Infect Dis 2010 Jan 15;50(2):133 full-text ), correction can
be found in Clin Infect Dis 2010 Jun 15;50(12):1695, commentary can be found in Clin Infect Dis
2010 Sep 15;51(6):757

Drainage
● percutaneous, transanal, or surgical drains may be used for International Study Group of Rectal
Cancer grade B and grade C leaks depending on location of anastomosis, size of abscess, and size of
defect 1 , 2

● the ability to perform image-guided percutaneous drainage is based upon having 2

⚬ safe radiographic window


⚬ experienced radiologist
⚬ homogeneity of uid
⚬ abscess ≥ 3 cm

● transanal drainage may be achieved in those anastomotic leaks (usually grade B) that can be reached

endoscopically, especially after failed percutaneous drainage 1 , 2


⚬ drainage is typically performed through the anastomotic dehiscence, with techniques ranging from
simply opening the defect to allow drainage, use of a formal surgical device, or drain insertion
⚬ follow-up x-ray with contrast through transanal drain may be performed to monitor abscess
⚬ drain typically removed when cavity has decreased to size of drain

Endoscopic therapies with stents, clips, glue, and suturing

● endoscopic therapies such as stents (most common), clips, glue, and suturing can be used alone or in

combination for management of anastomotic leaks in patients with 2 , 3


⚬ leaks refractory to 4 weeks of antibiotics and drainage
⚬ leaks presenting > 2-3 days after surgery or with signi cant peritoneal contamination (in
conjunction with antibiotics)
⚬ leaks that fail primary operative management

● self-expanding metal or covered stents can be used to help treat an anastomotic leak following

percutaneous drainage of the extraluminal abscess 2


⚬ stents are placed endoscopically under uoroscopic guidance

– stents are usually left in place for 2-8 weeks, with longer times associated with more di cult
extraction
– plastic stents may be more easily removed, but may have higher migration risk
– successful leak closure rates for combined plastic and metal stents reported to be about 88%
with majority being closed with 1 treatment
– stent placement allows for resumption of enteral feeding, which is theorized to accelerate
recovery
– Reference - Clin Gastroenterol Hepatol 2013 Apr;11(4):343

⚬ use of stents may be limited by complications, including

– stent migration (reported in > 40%) 2 , 3

● often requires repeat endoscopy or surgical removal


● endoscopic clips can be used to help reduce the risk for migration, but evidence for their
e cacy is limited
– gastrointestinal erosion requiring surgery 3

– less commonly

● anorectal pain
● incontinence
● perforation
● rectal bleeding
● stent obstruction
● Reference - World J Gastrointest Surg 2016 Sep 27;8(9):621 full-text

● glue injection, endoscopic clips, and suturing have each been used to help close anastomotic leaks,

often in conjunction with stenting 3


⚬ glue injected into anastomotic leak may help seal the wound and prevent continued contamination

– both brin and cyanoacrylate-based glues have been used, with no evidence to suggest
superiority of either
– glue injection alone might be an option for small leaks, but usually performed in addition to
stenting
⚬ endoscopic clips have limited data to support their use, though large, over-the-scope clips are
reported to be e ective in conjunction with stenting for some patients
⚬ suturing is rarely performed for management of anastomotic leaks, but has been used in patients
with late stulas at high risk for failure with primary operative repair

● in patients who develop an anastomotic leak after bariatric surgery 3

⚬ primary surgical repair > 2-3 days after leak or in patients with high peritoneal contamination is
unlikely to be successful
⚬ management typically requires endoscopic therapies, such as

– transluminal endoscopy

● characterized by entering the soiled peritoneal cavity through the leak, endoscopic
debridement, necrosectomy, irrigation, and drainage
● drainage catheters can be left in the peritoneum and traverse the leak, exiting transnasally
● transnasal peritoneal drain can be removed after systemic and local contamination has
resolved (the leak will seal if additional/continuing contamination is avoided)
– endoscopic stenting, with or without additional endoscopic glue injection, clips, or suturing

Endoscopic vacuum therapy (EVT)

Description and indications

● endoscopic vacuum therapy (EVT) (also called endoluminal vacuum therapy [EVAC]) is a minimally-
invasive technique for management of small or large bowel anastomotic leaks
⚬ technique involves placing a sponge attached to a nasogastric suctioning tube at the site of the
leak
⚬ reported to allow for healing via macrodeformation, microdeformation, perfusion changes, control
of exudate, and bacterial clearance, similar to healing mechanisms associated with wound
vacuums for management of skin wounds
⚬ may be used to treat anastomotic leaks following surgery to any part of the gastrointestinal tract
⚬ Reference - World J Gastrointest Endosc 2019 May 16;11(5):329 full-text

● no standardized indications for use have been established, but some indications include

⚬ acute and chronic anastomotic leaks < 5 cm


⚬ critically ill, hemodynamically unstable patients for infectious source control (if patient does not
respond to EVT therapy, surgery may still be required)
⚬ Reference - World J Gastrointest Endosc 2019 May 16;11(5):329 full-text
● absolute contraindications include

⚬ leaks in close proximity to major vessels


⚬ patients taking anticoagulants
⚬ patients with a bowel-cutaneous stula (EVT relies on the ability to create suction which is
prevented with atmospheric exposure)
⚬ Reference - World J Gastrointest Endosc 2019 May 16;11(5):329 full-text

● relative contraindications include

⚬ chronic anastomotic leaks > 6 weeks (due to associated with low closure rate)
⚬ anastomotic leaks > 5 cm (sponge size may be insu cient to occlude defect)
⚬ Reference - World J Gastrointest Endosc 2019 May 16;11(5):329 full-text

● in patients failing to respond to EVT, surgery is necessary to repair the leak (World J Gastrointest
Endosc 2019 May 16;11(5):329 full-text )

Procedure

● EVT for small bowel anastomotic leaks

⚬ start anesthesia, typically with endotracheal intubation for safe airway during passage of sponge
⚬ perform endoscopy to identify and characterize bowel wall defect
⚬ examine contaminated cavity with or without uoroscopy to determine appropriate sponge size
and placement
– standard size sponge is 3-7 cm in length and 2-3 cm in diameter (sponge size is limited by
diameter of esophagus)
– defects < 1 cm without an associated cavity can typically be managed with intraluminal sponge
placement
– larger defects may require dilation in order to access the cavity and place the sponge
extraluminally
⚬ place sponge at anastomotic leak with endoscope

– introduce nasogastric tube (NGT) into patient's nares and feed tube to posterior pharynx
– remove NGT from mouth using nger or grasper instrument
– secure sponge to tip of NGT using silk ties or permanent 2-0 silk or nonabsorbable sutures (or
larger)
– place nonabsorbable permanent suture at distal end of tube and tie into small loop to facilitate
endoscopic placement and retrieval
– place grasper through working channel of endoscope before insertion into patient's mouth,
then grasp short suture loop with device
– lubricate sponge and endoscope and insert into patient's mouth, moving endoscope distally
(avoid trauma to upper esophageal sphincter during insertion)
● if perforation is < 1 cm, move endoscope to intraluminal position at perforation site
● if perforation is ≥ 1 cm, move endoscope through perforation into cavity (may require
dilation to place sponge extraluminally)
– advance grasper while withdrawing endoscope and deposit sponge in appropriate position
– secure NGT to nose of patient
– connect suction tubing to vacuum therapy unit and canister
– attach NGT with sponge to canister tubing using custom adapter
– set vacuum therapy pressure to 125-175 mmHg at continuous moderate intensity
– vacuum therapy may be changed to intermittent suction (5 minutes on, 2 minutes o ) if patient
is uncomfortable
⚬ Reference - World J Gastrointest Endosc 2019 May 16;11(5):329 full-text

● EVT for large bowel anastomotic leaks

⚬ sedation or anesthesia may not be needed for EVT procedure for large bowel anastomotic leaks
but is often used
⚬ in most cases, a diverting stoma proximal to the leak site is necessary prior to EVT for lower
gastrointestinal tract leaks, which can be reversed following healing
⚬ perform exible endoscopic procedure to

– identify and characterize bowel wall defect


– examine contaminated cavity to determine sponge size

⚬ perform lavage
⚬ cut sponges according to the size of the cavity adjacent to the leak (for large cavities, 2 or more
sponges may be used)
⚬ insert colonoscope transanally to cavity
⚬ advance exible overtube over colonoscope to end of cavity, and retract colonoscope
⚬ push sponge through xed lubricated overtube to appropriate position
⚬ connect evacuation tube of sponge to vacuum bottle
⚬ electronic vacuum pump system may be used to maintain continuous suction at 125 mmHg
⚬ Reference - J Gastrointest Surg 2016 Feb;20(2):328

STUDY
● SUMMARY
endoscopic vacuum therapy associated with a high rate of complete healing of anastomotic
leakage and stoma reversal in patients with anastomotic leakage after colorectal surgery
DynaMed Level 2

SYSTEMATIC REVIEW: BJS Open 2019 Apr;3(2):153 | Full Text

Details
⚬ based on systematic review of mostly retrospective cohort studies
⚬ systematic review of 17 cohort studies (15 retrospective, 2 prospective) evaluating endoscopic
vacuum therapy (EVT) for management of anastomotic leakage following colorectal surgery in 276
patients
⚬ EVT associated with

– 85.3% weighted mean success rate (complete healing of anastomotic leakage), with a median
duration from EVT to complete healing of 47 days (range 40-105 days)
– 75.9% weighted mean rate of stoma reversal
– 11.1% weighted mean complication rate

⚬ factors associated with signi cantly increased risk for treatment failure included

– preoperative radiation therapy (p = 0.018)


– lack of diverting stoma prior to treatment (p = 0.009)
– development of complications (p = 0.002)
– male sex (p = 0.014)

⚬ Reference - BJS Open 2019 Apr;3(2):153 full-text

Postprocedural care

● sponge changes

⚬ exchange sponge every 3 days


⚬ to facilitate removal, saline or lidocaine may be placed into sponges through evacuation tube prior
to extraction
⚬ Reference - J Gastrointest Surg 2016 Feb;20(2):328

● nutritional support

⚬ small bowel anastomotic leaks managed with EVT require feeding tubes to allow for enteral
feeding access (World J Gastrointest Endosc 2019 May 16;11(5):329 full-text )
⚬ for colorectal leaks managed with EVT, parenteral nutrition usually given until adequate oral food
intake is possible (United European Gastroenterol J 2016 Dec;4(6):770 full-text )

Complications

● complications may include

⚬ pain, nausea, and vomiting from nasogastric tube


⚬ sponge dislocation
⚬ anastomotic strictures
⚬ bleeding

– minor bleeding can occur after sponge exchange due to growth of granulation tissue into
sponge (may be mitigated through more frequent sponge exchanges)
– major bleeding is less common, and typically reported in upper gastrointestinal leaks (perform
triple phase computed tomography to direct possible management)
⚬ Reference - World J Gastrointest Endosc 2019 May 16;11(5):329 full-text

● 20% complication rate reported with EVT, mainly from

⚬ anastomotic stenosis
⚬ repeat abscess and stulas
⚬ Reference - World J Gastrointest Surg 2016 Sep 27;8(9):621 full-text

STUDY
● SUMMARY
endoscopic vacuum therapy associated with high anastomotic salvage rate in patients with
colorectal anastomotic leaks DynaMed Level 3

SYSTEMATIC REVIEW: Surg Endosc 2019 Apr;33(4):1049 | Full Text

Details
⚬ based on systematic review of observational studies
⚬ systematic review of 36 cohort studies and case series (5 prospective cohorts, 4 retrospective
cohorts, 25 case series, and 2 case reports) evaluating endoscopic salvage techniques in 388 stable
patients with acute anastomotic leaks
⚬ meta-analysis not performed due to heterogeneity of study types and available data
⚬ 13 studies evaluated EVT in 197 patients

– mean 88.8% (range 66.6%-100%) anastomotic salvage rate


– very few complications (predominantly pain and stenosis) reported

⚬ Reference - Surg Endosc 2019 Apr;33(4):1049 full-text

Revision laparotomy

● revision laparotomy is indicated in addition to antibiotics in patients with peritonitis and sepsis
(following aggressive resuscitation if needed) and in those refractory to initial conservative
management with antibiotics and drainage 2
⚬ goals include source control with washout and fecal diversion
⚬ fecal diversion may include

– taking down anastomosis with construction of an end colostomy or ileostomy


– leaving anastomosis in place and creating a proximal diversion with loop ileostomy
– repairing or revising anastomosis and constructing a proximal diversion

⚬ minimally invasive surgery reported to have low morbidity and mortality compared to open
technique in peritoneal lavage and ileostomy construction

STUDY
● SUMMARY
salvage of anastomosis with loop ileostomy associated with decreased mortality compared to
anastomotic takedown in patients needing surgical intervention after anastomotic colorectal
leak DynaMed Level 2

COHORT STUDY: Am J Surg 2012 Nov;204(5):671

Details
⚬ based on retrospective cohort study
⚬ 93 patients (mean age 67.9 years) with anastomotic colorectal leak treated with salvage of the
anastomosis (with loop ileostomy) or anastomotic takedown as per surgeon's preference were
evaluated
– 42% of patients had salvage of the anastomosis and loop ileostomy (either drainage of
anastomosis and derivative loop ileostomy or reanastomosis and ileostomy)
– 58% of patients had anastomotic takedown with construction of an end colostomy or end
ileostomy
⚬ anastomotic leak de ned as ≥ 1 of following

– generalized or localized peritonitis


– pelvic abscess
– discharge of feces, pus, or gas from drain or wound

⚬ comparing loop ileostomy vs. anastomotic takedown

– mortality 15% vs. 37% (p = 0.02)


– overall morbidity (composite of all complications) 87.2% vs. 75.9% (not signi cant)

⚬ Reference - Am J Surg 2012 Nov;204(5):671

Complications and Prognosis

Complications

● anastomotic leak can result in severe, life-threatening complications, including

⚬ sepsis 1 , 2 , 3

⚬ peritonitis 2

⚬ local cancer recurrence in patients with surgery for colorectal cancer (cancer cells in resected

bowel may implant extraluminally via the leak) 2

● other complications may include

⚬ stula formation 3
⚬ abscess 3

⚬ stricture formation 2

STUDY
● SUMMARY
anastomotic leak after Roux-en-Y gastric bypass associated with increased mortality and
morbidity

COHORT STUDY: Arch Surg 2007 Oct;142(10):954

Details
⚬ based on retrospective cohort study
⚬ 840 patients (median age 45 years) having Roux-en-Y gastric bypass were analyzed with follow-up
of 11 months
⚬ 4.3% developed anastomotic leaks
⚬ 35 patients died during follow-up
⚬ comparing patients with anastomotic leak vs. no anastomotic leak

– mortality 14% vs. 4% (p = 0.01)


– overall complications 61% vs. 29% (p < 0.001)
– duration of hospital stay 24.5 days vs. 4.5 days (p < 0.001)

⚬ anastomotic leak associated with increased risk of complications including

– sepsis (odds ratio [OR] 27, 95% CI 2-472)


– renal failure (OR 16, 95% CI 3-99)
– small bowel obstruction (OR 11, 95% CI 2-68)
– internal hernia (OR 10, 95% CI 2-51)
– venous thromboembolism (OR 9, 95% CI 3-27)
– incisional hernia (OR 5, 95% CI 2-13)

⚬ Reference - Arch Surg 2007 Oct;142(10):954

Prognosis

● most early leaks (occurring within 3 days of surgery) in stable patients without sepsis can be

successfully managed with conservative treatment 3

● mortality

⚬ reported in about 0.5%-29% of patients with anastomotic leak 1 , 3

⚬ 0.4% mortality due to anastomotic leak in systematic review of 39 studies with 24,232 patients
(8.6% of whom developed anastomotic leak) following rectal carcinoma resection (Int Surg 2014
Mar-Apr;99(2):112 full-text )

STUDY
⚬ SUMMARY
anastomotic leak associated with increased risk for local recurrence and reduced overall and
cancer-specific survival in patients with curative anterior resection for rectal cancer

SYSTEMATIC REVIEW: World J Surg 2017 Jan;41(1):277 | Full Text

Details
– based on systematic review of observational studies
– systematic review of 14 cohort studies (7 prospective, 7 retrospective) evaluating e ects of
anastomotic leak in 11,353 patients after curative anterior resection for rectal cancer
– anastomotic leak associated with

● increased risk for local recurrence (hazard ratio [HR] 1.71, 95% CI 1.22-2.38) in analysis of 9
studies with 6,638 patients
● decreased overall survival (HR 1.67, 95% CI 1.19-2.35) in analysis of 10 studies with 9,309
patients, results limited by signi cant heterogeneity
● decreased cancer-speci c survival (HR 1.3, 95% CI 1.08-1.56) in analysis of 7 studies with
6,516 patients
– no signi cant di erences in risk for distant recurrence in analysis of 3 studies with 2,397
patients
– Reference - World J Surg 2017 Jan;41(1):277 full-text

STUDY
⚬ SUMMARY
open gastric bypass surgery and jejunojejunostomy leaks each associated with increased
mortality in patients with anastomotic leak following Roux-en-Y gastric bypass surgery

COHORT STUDY: J Gastrointest Surg 2007 Jun;11(6):708

Details
– based on retrospective cohort study
– 3,828 patients with Roux-en-Y gastric bypass procedure were evaluated

● 61.1% had open gastric bypass


● 28.2% had laparoscopic gastric bypass
● 10.7% had revision procedure

– 3.9% of patients developed anastomotic leak, with leak-related mortality 0.6%


– comparing mortality rates in patients who developed leaks

● 24.6% with open surgery vs. 8.9% with laparoscopic surgery (p = 0.025)
● 40% with jejunojejunostomy leaks vs. 9% with gastrojejunostomy leaks (p = 0.005)

– Reference - J Gastrointest Surg 2007 Jun;11(6):708

STUDY
● SUMMARY
anastomotic leak following curative resection for colon cancer associated with delay in or
decreased likelihood of receiving chemotherapy, and increased risk of disease recurrence and
all-cause mortality at 5 years

COHORT STUDY: Ann Surg 2014 May;259(5):930

Details
⚬ based on retrospective cohort study
⚬ 9,333 patients who had surgery for colon cancer with primary anastomosis without protecting
ostomy were analyzed
⚬ 6.4% had anastomotic leak
⚬ 744 patients died within 120 days
⚬ 8,589 patients who survived > 120 days were followed for median 5.3 years

– 14.9% had distant recurrence


– 10% had local recurrence

⚬ compared to no anastomotic leak, anastomotic leak associated with


– greater delay to initial administration of chemotherapy (p < 0.001)
– decreased likelihood of receiving adjuvant chemotherapy (adjusted hazard ratio [HR] 0.58, 95%
CI 0.45-0.74)
– increased risk of distant recurrence (adjusted HR 1.42, 95% CI 1.13-1.78)
– increased all-cause mortality (adjusted HR 1.2, 95% CI 1.01-1.44)

⚬ Reference - Ann Surg 2014 May;259(5):930 , commentary can be found in Ann Surg 2016
Feb;263(2):e17

Prevention

Surgical techniques associated with reduced risk for anastomotic leak

● mechanical bowel preparation plus oral antibiotics

STUDY
⚬ SUMMARY
oral antibiotics plus mechanical bowel preparation, but not mechanical bowel preparation
alone, may reduce risk for anastomotic leak and surgical site infection (SSI) after elective
colorectal surgery

COHORT STUDY: Ann Surg 2018 Apr;267(4):734

Details
– based on retrospective cohort study
– 32,359 patients (mean age 61 years, 52% female) having elective colorectal resection between
2012 and 2014 were evaluated at 30 days postoperatively
● 32.9% had mechanical bowel preparation plus oral antibiotics
● 36.6% had mechanical bowel preparation alone
● 3.8% had oral antibiotics alone
● 26.7% had no bowel preparation

– 9% of patients (2,896) developed SSI


– 27,698 patients included in propensity-adjusted analyses for outcomes
– compared to no bowel preparation

● reduced risk of anastomotic leak with

⚬ mechanical bowel preparation plus oral antibiotics (adjusted odds ratio [OR] 0.53, 95% CI
0.43-0.64)
⚬ oral antibiotics alone (adjusted OR 0.37, 95% CI 0.21-0.67)

● reduced risk of SSI with

⚬ mechanical bowel preparation plus oral antibiotics (adjusted OR 0.45, 95% CI 0.4-0.5)
⚬ oral antibiotics alone (adjusted OR 0.49, 95% CI 0.38-0.64)

● mechanical bowel preparation plus oral antibiotics associated with reduced risk of

⚬ postoperative ileus (adjusted OR 0.83, 95% CI 0.43-0.64)


⚬ hospital readmission (adjusted OR 0.87, 95% CI 0.79-0.97)

– no signi cant di erences in

● rate of anastomotic leak comparing mechanical bowel preparation alone to no bowel


preparation
● rate of SSI comparing mechanical bowel preparation alone to no bowel preparation
● risk of cardiac or renal complications with any type of bowel preparation compared to no
bowel preparation
– Reference - Ann Surg 2018 Apr;267(4):734

STUDY
● SUMMARY
defunctioning stoma may reduce risk of anastomotic leak and reoperation after anterior
resection in patients with rectal cancer DynaMed Level 2

COCHRANE REVIEW: Cochrane Database Syst Rev 2010 May 12;(5):CD006878

Details
⚬ based on Cochrane review of trials with methodologic limitations
⚬ Cochrane review of 6 randomized trials comparing use of defunctioning stoma vs. no stoma in 648
patients with rectal cancer having low anterior resection
⚬ defunctioning stomas are temporary stomas created to protect a more distal anastomosis at
particular risk of leakage or breakdown in order to improve healing
⚬ all trials had ≥ 1 methodologic limitation including

– unclear randomization
– no blinding
– no intention-to-treat analysis

⚬ defunctioning stoma associated with lower risk of

– anastomotic leak in analysis of all trials

● risk ratio (RR) 0.33 (95% CI 0.21-0.53)


● NNT 7-11 with leak in 20% of controls

– urgent reoperation in analysis of all trials

● RR 0.23 (95% CI 0.12-0.42)


● NNT 6-10 with urgent reoperation in 20% of controls

⚬ no signi cant di erence in mortality in analysis of all trials


⚬ Reference - Cochrane Database Syst Rev 2010 May 12;(5):CD006878

⚬ similar results in systematic review of 25 studies evaluating defunctioning stoma after low anterior
resection for rectal cancer (Br J Surg 2009 May;96(5):462 ), commentary can be found in Br J Surg
2009 Nov;96(11):1374

STUDY
● SUMMARY
transanal tubes may help prevent anastomotic leak in patients having rectal cancer surgery with
anastomosis DynaMed Level 2

SYSTEMATIC REVIEW: World J Surg 2017 Jan;41(1):267

Details
⚬ based on systematic review of trials with methodologic limitations
⚬ systematic review of 7 trials (1 randomized trial, 6 non-randomized trials) evaluating transanal
tubes in 1,609 adults having rectal cancer surgery with anastomosis
⚬ transanal tubes di ered in types, materials, sizes, position, and indwelling time
⚬ all trials had ≥ 1 of these methodologic limitations

– lack of randomization
– unclear randomization sequence generation
– lack of allocation concealment
– lack of blinding
– small sample size

⚬ compared to no transanal tubes, use of transanal tubes associated with reduced

– anastomotic leak (relative risk [RR] 0.38, 95% CI 0.25-0.58) in analysis of 7 trials with 1,609
patients
– reoperation (RR 0.31, 95% CI 0.19-0.53) in analysis of 7 trials with 1,609 patients

⚬ no signi cant di erences in mortality in analysis of 6 trials with 1,404 patients


⚬ Reference - World J Surg 2017 Jan;41(1):267

STUDY
● SUMMARY
robotic bariatric surgery may decrease risk of anastomotic leak compared to laparoscopic
bariatric surgery DynaMed Level 2

SYSTEMATIC REVIEW: Obes Surg 2016 Dec;26(12):3031

Details
⚬ based on systematic review of mostly observational studies
⚬ systematic review of 34 studies (2 randomized trials and 32 observational studies) comparing
robotic vs. laparoscopic bariatric surgery in obese patients
⚬ bariatric surgery types included Roux-en-Y gastric bypass, sleeve gastrectomy, and gastric banding
⚬ robotic bariatric surgery associated with

– decreased risk of anastomotic leak (odds ratio 0.5, 95% CI 0.3-0.81) in analysis of 19 studies,
results limited by signi cant heterogeneity
– increased operative time (p < 0.0005) in analysis of 19 studies

⚬ Reference - Obes Surg 2016 Dec;26(12):3031

STUDY
● SUMMARY
end-to-side anastomosis associated with lower anastomotic leak rate than end-to-end
anastomosis after anterior resection of rectal cancer DynaMed Level 2

RANDOMIZED TRIAL: J Surg Oncol 2009 Jan 1;99(1):75

Details
⚬ based on randomized trial with allocation concealment not stated
⚬ 77 patients having anterior resection of rectal cancer (T1-T2 ≤ 15 cm from anal verge) were
randomized to end-to-side anastomosis vs. end-to-end anastomosis using left colon
⚬ anastomotic leak in 5% with end-to-side anastomosis vs. 29.2% with end-to-end anastomosis (p =
0.005, NNT 5)
⚬ Reference - J Surg Oncol 2009 Jan 1;99(1):75

Surgical techniques not associated with reduced risk for anastomotic leak

● omentoplasty 1

● mechanical bowel preparation alone (without oral antibiotics)

STUDY
⚬ SUMMARY
mechanical bowel preparation alone (without oral antibiotics) may not reduce rate of
anastomotic leak, peritonitis, or wound infection in patients having elective colorectal
surgery DynaMed Level 2

COCHRANE REVIEW: Cochrane Database Syst Rev 2011 Sep 7;(9):CD001544 | Full Text

Details
– based on 1 Cochrane review and 1 systematic review with wide con dence intervals that cannot
exclude clinically important di erences
– systematic review of 18 randomized trials evaluating mechanical bowel preparation (without
oral antibiotics) in 5,805 patients having elective colorectal surgery
– wide con dence intervals includes possibility of both bene t and harm
– no signi cant di erence comparing mechanical bowel preparation to no preparation in

● overall anastomotic leak in analysis of 13 trials with 4,533 patients


● anastomotic leak after low anterior resection in subgroup analysis of 7 trials with 846
patients
● anastomotic leak after colonic surgery in subgroup analysis of 8 trials with 3,147 patients
● peritonitis in analysis of 10 trials with 3,983 patients
● reoperation in analysis of 11 trials with 4,319 patients
● wound infection in analysis of 13 trials with 4,595 patients
● infectious extra-abdominal complications in analysis of 6 trials with 3,575 patients

– similar results in sensitivity analyses of trials with adequate randomization or in patients with
anastomosis
– no signi cant di erence in any outcomes comparing mechanical bowel preparation to rectal
enema in 5 trials with 1,210 patients
– Reference - Cochrane Database Syst Rev 2011 Sep 7;(9):CD001544 full-text
– consistent results found in systematic review of 18 trials evaluating mechanical bowel
preparation without the use of oral antibiotics (Dis Colon Rectum 2015 Jul;58(7):698 ),
commentary can be found in Dis Colon Rectum 2016 Aug;59(8):e421

⚬ commentary on mechanical bowel preparation outcomes without oral antibiotics can be found in
Dis Colon Rectum 2016 Aug;59(8):e421

STUDY
● SUMMARY
C-shield biodegradable intraluminal sheath does not prevent anastomotic leak in patients
having colorectal resection with stapled anastomosis DynaMed Level 1

RANDOMIZED TRIAL: Br J Surg 2017 Jul;104(8):1010

Details
⚬ based on randomized trial
⚬ 485 adults having elective colorectal resection with stapled circular anastomosis < 15 cm from anal
verge were randomized to biodegradable intraluminal soft sheath (C-seal) vs. no C-seal (control)
– biodegradable C-seal was stapled to a erent bowel loop proximal to anastomosis for preventing
intestinal leakage in case of anastomotic dehiscence
– trial protocol amended to include mechanical oral bowel preparation before use of C-seal
following safety analysis in rst 46 patients
⚬ primary endpoint was anastomotic leak requiring invasive treatment within 30 days after primary
surgery
⚬ trial terminated early for futility at rst interim analysis using prespeci ed stopping rule
⚬ 402 patients (median age 65 years) included in analysis
⚬ comparing C-seal vs. control

– primary endpoint in 10.4% vs. 5% (p = 0.06)


– dismantled anastomoses in 5% vs. 1.5% (p = 0.09)
– defunctioning stomas in 50% vs. 50.5% (not signi cant)
– median interval between surgery and anastomotic leak 6 days vs. 4.5 days (not signi cant)
– median duration of hospital stay 14 days vs. 13 days (not signi cant)

⚬ Reference - C-seal trial (Br J Surg 2017 Jul;104(8):1010 )

STUDY
● SUMMARY
reinforcement of stapled circular anastomosis > 5 cm from anal verge with bioabsorbable device
may not reduce anastomotic complications in patients having colorectal surgery
DynaMed Level 2

RANDOMIZED TRIAL: Dis Colon Rectum 2014 Oct;57(10):1195

Details
⚬ based on single-blind randomized trial
⚬ 302 patients (median age 66 years) having elective colorectal surgery with stapled circular
anastomosis > 5 cm from anal verge were randomized to staple line reinforcement with
bioabsorbable device vs. no reinforcement and followed for 12 months
⚬ 93% of patients received assigned intervention of bioabsorbable staple line reinforcement and
were included in analyses
⚬ no signi cant di erences between groups in

– anastomotic complications, including leak, hemorrhage, and stenosis


– length of hospital stay
– reoperation rate

⚬ Reference - Dis Colon Rectum 2014 Oct;57(10):1195

● inconsistent evidence for reduced risk of anastomotic bowel leaks for

⚬ application of medical adhesives including cyanoacrylate and brin adhesives (Pol Przegl Chir 2017
Apr 30;89(2):49 )
⚬ gastric tube placement in Roux-en-Y gastric bypass (Pol Przegl Chir 2017 Apr 30;89(2):49 )
⚬ prophylactic drains

STUDY
– SUMMARY
prophylactic anastomotic drainage does not appear to prevent colorectal surgery
complications compared to nondrainage regimens DynaMed Level 2

COCHRANE REVIEW: Cochrane Database Syst Rev 2004 Oct 18;(4):CD002100

Details
● based on Cochrane review without individual trial quality assessment reported
● systematic review of 6 randomized trials comparing prophylactic anastomotic drainage vs. no
drainage in 1,140 patients receiving colorectal anastomoses
● no signi cant di erences comparing drainage and nondrainage regimens in

⚬ mortality (3%-4%)
⚬ clinical anastomotic dehiscence (1%-2%)
⚬ radiological anastomotic dehiscence (3%-4%)
⚬ wound infection (5%)
⚬ reintervention (5%-6%)
⚬ extra-abdominal complications (6%-7%)

● Reference - Cochrane Database Syst Rev 2004 Oct 18;(4):CD002100 (review updated 2008
Aug 5), also published in Colorectal Dis 2006 May;8(4):259

STUDY
– SUMMARY
prophylactic pelvic drainage might reduce risk for anastomotic leak in patients having
anterior rectal resection with extraperitoneal colorectal anastomoses

SYSTEMATIC REVIEW: Colorectal Dis 2014 Feb;16(2):O35

Details

DynaMed Level 2

● based on systematic review of mostly observational studies


● systematic review of 8 studies (3 randomized trials and 5 observational studies) evaluating
prophylactic pelvic drainage in 2,277 patients having anterior rectal resection with
extraperitoneal anastomoses
● compared to no drainage, pelvic drainage associated with

⚬ reduced anastomotic leak (odds ratio [OR] 0.51, 95% CI 0.36-0.73) in analysis of 3
randomized trials and 5 observational studies with 2,277 patients
⚬ no signi cant di erence in anastomotic leak in analysis of 3 randomized trials with 291
patients (OR 0.98, 95% CI 0.49-1.99)
● Reference - Colorectal Dis 2014 Feb;16(2):O35

Guidelines and Resources

Guidelines

International guidelines

● Enhanced Recovery After Surgery Society/European Society for Clinical Nutrition and
Metabolism/International Association for Surgical Metabolism and Nutrition (ERAS/ESPEN/IASMEN)
guideline on perioperative care in elective colonic surgery can be found in World J Surg 2013
Feb;37(2):259

United States guidelines

● American Association of Clinical Endocrinologists/American College of Endocrinology/The Obesity


Society/American Society for Metabolic and Bariatric Surgery/Obesity Medicine Association/American
Society of Anesthesiologists (AACE/ACE/TOS/ASMBS/OMA/ASA) clinical practice guideline on
perioperative nutritional, metabolic, and nonsurgical support of bariatric surgery patient can be found
in Obesity (Silver Spring) 2020 Apr;28(4):O1
● American Society of Colon and Rectal Surgeons/Society of American Gastrointestinal and Endoscopic
Surgeons (ASCRS/SAGES) clinical practice guideline on enhanced recovery after colon and rectal
surgery can be found in Dis Colon Rectum 2017 Aug;60(8):761 , commentary can be found in Dis
Colon Rectum 2018 Feb;61(2):e13

● Surgical Infection Society/Infectious Diseases Society of America (SIS/IDSA) guideline on diagnosis and
management of complicated intra-abdominal infection in adults and children can be found in Clin
Infect Dis 2010 Jan 15;50(2):133 full-text , correction can be found in Clin Infect Dis 2010 Jun
15;50(12):1695, commentary can be found in Clin Infect Dis 2010 Sep 15;51(6):757

Canadian guidelines

● Canadian Society of Colon and Rectal Surgeons (CSCRS) guideline on preoperative bowel preparation
for patients undergoing elective colorectal surgery can be found in Can J Surg 2010 Dec;53(6):385
full-text

Review articles

● review of predictive factors for anastomotic leak after laparoscopic surgery can be found in World J
Gastroenterol 2018 Jun 7;24(21):2247 full-text

● review of anastomotic failure in colorectal surgery can be found in Indian J Surg 2018 Apr;80(2):163

● review of endoscopic management of transmural defects, including leaks, perforations, and stulae
can be found in Gastroenterology 2018 May;154(7):1938

● review of integrated approach to colorectal anastomotic leak can be found in World J Gastroenterol
2016 Aug 28;22(32):7226 full-text

● review of management of colorectal anastomotic leak can be found in Clin Colon Rectal Surg 2016
Jun;29(2):138 full-text

● review of endoscopic management of bariatric complications including anastomotic leaks can be


found in World J Gastrointest Endosc 2015 May 16;7(5):518 full-text

MEDLINE search

● to search MEDLINE for (Anastomotic leak) with targeted search (Clinical Queries), click therapy ,
diagnosis , or prognosis

Patient Information

● DynaMed Editors have not identi ed patient education materials that meet our criteria for inclusion
(freely accessible, nonpromotional, topic-speci c). We will continue to search for acceptable materials
and welcome your suggestions.

ICD Codes

ICD-10 codes

● K91.8 other postprocedural disorders of digestive system, not elsewhere classi ed


References

General references used

1. An V, Chandra R, Lawrence M. Anastomotic Failure in Colorectal Surgery: Where Are We at? Indian J
Surg. 2018 Apr;80(2):163-170

2. Thomas MS, Margolin DA. Management of Colorectal Anastomotic Leak. Clin Colon Rectal Surg. 2016
Jun;29(2):138-44 full-text

3. Bhayani NH, Swanström LL. Endoscopic therapies for leaks and stulas after bariatric surgery. Surg
Innov. 2014 Feb;21(1):90-7

Recommendation grading systems used

● Surgical Infection Society/Infectious Diseases Society of America (SIS/IDSA) grading system for
recommendations
⚬ strength of recommendation

– Grade A - good evidence to support a recommendation for or against use


– Grade B - moderate evidence to support a recommendation for or against use
– Grade C - poor evidence to support a recommendation

⚬ quality of evidence

– Level I - evidence from ≥ 1 properly randomized, controlled trial


– Level II - evidence from ≥ 1 well-designed clinical trial, without randomization; from cohort or
case-controlled analytic studies (preferably from > 1 center); from multiple time-series; or from
dramatic results from uncontrolled experiments
– Level III - evidence from ≥ 1 well-designed clinical trial, without randomization; from cohort or
case-controlled analytic studies (preferably from > 1 center); from multiple time-series; or from
dramatic results from uncontrolled experiments
⚬ Reference - SIS/IDSA guideline on diagnosis and management of complicated intra-abdominal
infection in adults and children (Clin Infect Dis 2010 Jan 15;50(2):133 full-text ), correction can
be found in Clin Infect Dis 2010 Jun 15;50(12):1695

● American Association of Clinical Endocrinologists/American College of Endocrinology/The Obesity


Society/American Society for Metabolic and Bariatric Surgery/Obesity Medicine Association/American
Society of Anesthesiologists (AACE/ACE/OS/ASMBS/OMA/ASA) grading system for recommendations
⚬ grades of recommendation

– Grade A

● level 1 evidence with no subjective factor impact OR


● level 2 evidence with positive subjective factor impact
● any evidence level if there is 100% consensus

– Grade B

● level 2 evidence with no subjective factor impact OR


● level 1 evidence with negative subjective factor impact OR
● level 3 evidence with positive subjective factor impact

– Grade C

● level 3 evidence with no subjective factor impact OR


● level 2 evidence with negative subjective factor impact OR
● level 4 evidence with positive subjective factor impact

– Grade D

● level 4 evidence with no subjective factor impact OR


● level 3 evidence with negative subjective factor impact
● if a two-thirds consensus cannot be reached, then the recommendation grade is D,
regardless of the presence or absence of strong subjective factors
– Grade AD

● any evidence level with positive and/or negative subjective factor impact and a two-thirds
consensus
⚬ best evidence level (BEL)

– Level 1 - based on randomized controlled trial or meta-analysis of randomized controlled trials


– Level 2 - based on nonrandomized controlled trial, meta-analysis of nonrandomized prospective
or case-controlled trials, prospective cohort study, network meta-analysis, nested case-control
study, cross-sectional study, surveillance study (registries, surveys, epidemiologic study), open-
label extension study, post-hoc analysis study, or retrospective case-control study
– Level 3 - based on discovery science, economic study, consecutive case series, single case
reports, preclinical study, or basic research
– Level 4 - no evidence (theory, opinion, consensus, or review) or other (lower impact/relevant
basic research, any highly awed study)
⚬ Reference - AACE/ACE/OS/ASMBS/OMA/ASA clinical practice guideline on perioperative nutrition,
metabolic, and nonsurgical support of patients undergoing bariatric procedures- 2019 update
(Obesity (Silver Spring) 2020 Apr;28(4):O1 )

Synthesized Recommendation Grading System for DynaMed Content

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the most valid relevant evidence to support clinical decision-making (see 7-Step Evidence-Based
Methodology ).

● Guideline recommendations summarized in the body of a DynaMed topic are provided with the
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● In DynaMed content, we synthesize the current evidence, current guidelines from leading authorities,
and clinical expertise to provide recommendations to support clinical decision-making in the Overview
& Recommendations section.

● We use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to


classify synthesized recommendations as Strong or Weak.
⚬ Strong recommendations are used when, based on the available evidence, clinicians (without
con icts of interest) consistently have a high degree of con dence that the desirable consequences
(health bene ts, decreased costs and burdens) outweigh the undesirable consequences (harms,
costs, burdens).
⚬ Weak recommendations are used when, based on the available evidence, clinicians believe that
desirable and undesirable consequences are nely balanced, or appreciable uncertainty exists
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How to cite

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● DynaMed [Internet]. Ipswich (MA): EBSCO Information Services. 1995 - . Record No. T922759,
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