Surgery for Obesity and Related Diseases 15 (2019) 1530–1540

Original article

Effects of intraoperative leak testing on postoperative leak-related

outcomes after primary bariatric surgery: an analysis of the MBSAQIP
database
Kamthorn Yolsuriyanwong, M.D., F.R.C.S.T.a,b, Thammasin Ingviya, M.D., M.H.S., Ph.D.c,
Chanon Kongkamol, M.D., M.Sc., Ph.D.c, Eric Marcotte, M.D., M.Sc., F.A.C.S.,
F.A.S.M.B.S.a, Bipan Chand, M.D., FA.C.S., F.A.S.M.B.S., F.A.S.G.E.a,*
a
Department of Surgery, Division of Gastrointestinal/Minimally Invasive Surgery, Loyola University Chicago Stritch School of Medicine, Maywood,
Illinois
b
Department of Surgery, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand
c
Department of Family Medicine and Preventive Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand
Received 11 January 2019; accepted 1 June 2019

Abstract Background: Intraoperative leak test (IOLT) is commonly performed to evaluate the integrity of an
anastomosis or staple line during bariatric surgery. However, the utility of IOLT is controversial.
Objective: To evaluate the effect of IOLT on postoperative leak-related outcomes after primary bar-
iatric surgery.
Setting: Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program–
accredited centers.
Methods: The 2015 and 2016 Metabolic and Bariatric Surgery Accreditation and Quality Improve-
ment databases were analyzed for sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and
biliopancreatic diversion with duodenal switch (BPDDS) to determine the postoperative anastomotic/
staple line leak (A/SL) and leak-related outcomes.
Results: Data for a total of 265,309 patients who underwent SG (69.6%), RYGB (29.7%), or
BPDDS (.8%) were analyzed. IOLT was performed in 81.9% of all patients. Overall A/SL, mor-
tality rate in patients with leakage, and 30-day leak-related mortality were .28%, .1%, and .003%,
respectively. There were no significant differences between the IOLT and non-IOLT groups in
terms of A/SL, 30-day mortality in patients with leakage, 30-day leak-related mortality, readmis-
sion, reoperation, intervention, or organ/space surgical site infection. However, the rate of 30-day
leak-related intervention in BPDDS was significantly lower in the IOLT group compared to the
non-IOLT group (.18% versus 1.15%, P 5 .01). Whether IOLT was performed endoscopically
or nonendoscopically had no effect on the rate of postoperative leaks. Overall mean operative
time increased by 19.1 minutes (9.5, 11.9, and 21.2 min for SG, RYGB, and BPDDS, respectively)
when IOLT was performed.
Conclusion: The overall rate of postoperative A/SL and leak-related morbidity was low. This study
provided no evidence of either benefit or harm from IOLT in patients who underwent SG, RYGB, or
BPDDS. (Surg Obes Relat Dis 2019;15:1530–1540.) Ó 2019 American Society for Bariatric Surgery.
Published by Elsevier Inc. All rights reserved.

* Correspondence: Bipan Chand, M.D., Department of Surgery, Division Stritch School of Medicine, 2160 South First Avenue, Maywood,
of Gastrointestinal/Minimally Invasive Surgery, Loyola University Chicago Illinois, 60153.
E-mail address: bchand@lumc.edu (B. Chand).

https://doi.org/10.1016/j.soard.2019.06.008
1550-7289/Ó 2019 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
 Kamthorn Yolsuriyanwong et al. / Surgery for Obesity and Related Diseases 15 (2019) 1530–1540
Key words: Intraoperative leak test; Anastomosis/staple line leak; Leak-related mortality; Reoperation; Readmission; Inter-
vention; Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)
Postoperative gastrointestinal leak is one of the serious
complications that can occur after bariatric surgery. The
rates of leaks after bariatric surgery vary from 0% to 7% af-
ter sleeve gastrectomy (SG), 0% to 5.6% after Roux-en-Y
gastric bypass (RYGB), and .7% to 8% after biliopancreatic
diversion with duodenal switch (BPDDS) [1–8]. Even
though the occurrence of leaks has been low and has
continued to decrease over time, postoperative
gastrointestinal leaks remain an important cause of
morbidity and mortality [5,6,9].
Several strategies have been introduced to decrease post-
operative leaks [1,3,9]. An intraoperative leak test (IOLT) is
a common intraoperative intervention to identify
anastomotic or staple line leaks (A/SL) and is often
performed by air insufflation or methylene blue dye
injection using naso/orogastric tube placement or upper
gastrointestinal endoscopy. Identification of a leak by
IOLT can allow surgeons to repair and perform closure of
the leak site intraoperatively and can help prevent
postoperative leakage. Leaks may lead to readmission,
postoperative intervention, and reoperation.
However, the utility of IOLT during bariatric surgery is
controversial. Some reports have shown that the advantage
of IOLT is a reduction of postoperative leaks [10–13].
However, other studies have shown that IOLT had no
correlation with a leak and was not associated with a
decrease in the incidence of postoperative leaks [14–17].
Moreover, this intervention can cause iatrogenic injury
and prolonged operative time and is associated with
increased costs and resource utilization [13,14,18].
Therefore, the purpose of this study was to determine the
effect of IOLT on postoperative leak-related outcomes in pa-
tients who underwent primary bariatric surgery.
Methods
Data source
The Metabolic and Bariatric Surgery Accreditation and
Quality Improvement Program (MBSAQIP) database has
.200 variables of prospectively collected data related to pa-
tient outcomes of all accredited bariatric surgical centers.
The data include patient characteristics, preoperative risk
factors, intraoperative details, and 30-day postoperative
mortality and morbidity outcomes. The participant data
user file (PUF) of 2015 and 2016 is available for MBSAQIP
participants and contains .355,000 bariatric cases from
.790 centers. The PUF data set contains patient-level
data that are de-identified and thus do not identify hospitals,
healthcare providers, or patients.
1531
Study population
All patients within the 2015 and 2016 MBSAQIP PUF
who underwent primary bariatric surgery indicated by the
Current Procedural Terminology (CPT) codes for SG
(43775), RYGB (43644 and 43645), and BPDDS (43845)
were included in our analysis. Revisional, emergent, previ-
ous obesity or foregut surgery, and open approach or
conversion-to-open cases were excluded.
Study design and outcome measurements
According to MBSAQIP, a provocative test to assess for
leaks is defined as insufflation of air through an endoscope
or a naso/orogastric tube with the anastomosis under saline
to look for bubbles during the initial bariatric or metabolic
surgical procedure. Alternatively, methylene blue (or other
liquid) can be instilled under pressure to look for fluid leaks
after the bowel is clamped distal to the anastomosis or staple
line during the initial bariatric or metabolic surgical proced-
ure. Cases involving the use of an intraoperative provocative
test to assess for a leak were retrieved from the database and
categorized into 2 groups of patients—patients who had and
patients who did not have an IOLT. Patients who underwent
an IOLT were compared with those who did not have an
IOLT.
Patient demographic characteristics, clinical status, and
operative information from the MBSAQIP PUF were used
for risk adjustment. Patient characteristics included sex,
age, and ethnicity. Clinical variables included the most
recent body mass index before surgery, American Society
of Anesthesiologists class, gastroesophageal reflux disease,
history of myocardial infarction, history of percutaneous
coronary interventions/percutaneous transluminal coronary
angioplasty, previous cardiac surgery, hyperlipidemia, hy-
pertension, history of deep vein thrombosis, venous stasis,
dialysis, renal insufficiency, therapeutic anticoagulation,
diabetes mellitus, smoking status, dependent functional sta-
tus, chronic obstructive pulmonary disease, oxygen depen-
dence, history of pulmonary embolism, obstructive sleep
apnea, chronic steroid use, inferior vena cava filter, albumin
level, and hematocrit level. Operative variables included
technical variables for SG (bougie size, pyloric distance,
staple line reinforcement or oversewing or both), type of
first assistant, surgical approach, operative time, the use of
a drain at the time of the initial operation, the performance
of a swallow study on the day of or the day after the proced-
ure, and the use of intraoperative gastrointestinal endoscopy.
The primary outcome was postoperative A/SL. Secondary
outcomes were 30-day mortality in patients with leakage;
1532 Kamthorn Yolsuriyanwong et al. / Surgery for Obesity and Related Diseases 15 (2019) 1530–1540
30-day leak-related mortality, reoperation, readmission,
intervention, organ/space surgical site infection (SSI); and
operative time for the entire cohort and for each type of bar-
iatric surgery including SG, RYGB, and BPDDS.
Postoperative leak-related outcomes were defined accord-
ing to the 2018 MBSAQIP Semiannual Report and the 2018
MBSAQIP Operations Manual. A/SL was defined as at least
1 reoperation, intervention, or readmission that occurred
within 30 days of the index procedure with the most likely
reason given as “anastomotic/staple line leak.” Thirty-day
mortality in patients with a leak was defined as a mortality
that occurred within 30 days after surgery due to any cause
of death in patients with anastomosis or staple line leak,
with the bariatric committee having reviewed the death.
Thirty-day leak-related mortality, reoperation, readmission,
and intervention were defined as mortality, reoperation, read-
mission, or intervention that occurred within 30 days after
surgery with the most likely cause of death, reoperation,
readmission, or intervention given as “anastomosis/staple
line leak” and with the death having been reviewed by the
bariatric committee. Organ/space SSI was defined as an
infection that involved any part of the anatomy in the oper-
ating field (e.g., organs or spaces), other than the incision,
which was opened or manipulated during an operation and
occurred within 30 days of the index procedure.
Furthermore, we analyzed outcomes in the subgroup of pa-
tients who underwent IOLT using an upper gastrointestinal
endoscopy compared with the subgroup of patients who un-
derwent IOLT using a nonendoscopic method. Although the
MBSAQIP PUF does not provide data on the specific tech-
nique used in an IOLT, there are 2 common methods for
IOLT during bariatric surgery—upper gastrointestinal endos-
copy and naso/orogastric tube placement. We captured the pa-
tients who had IOLT using upper gastrointestinal endoscopy
by CPT codes for endoscopy (43200 or 43235) in other pro-
cedures and concurrent procedures. We assumed that the
remainder of the patients without these CPT codes underwent
naso/orogastric tube placement for the IOLT. MBSAQIP pro-
vided approval to use the patient-level data for this study.
Statistical analysis
Descriptive statistics (mean and standard deviation, me-
dian and interquartile range, number and percentages) were
used to characterize the patient population where applicable.
To compare the distribution of categorical variables between
the successful and unsuccessful surgical outcomes, the c2
statistic or Fisher exact test was used. The unpaired t test
or Wilcoxon test was used to compare the distribution of
continuous variables on the outcomes depending on the
data distribution. For inferential statistics, multivariate logis-
tic models were created for each of the outcomes of interest.
All variables previously listed were included within the ana-
lyses. The potential risk factors for surgical leakage were
identified based mainly on hierarchical regression using
Akaike Information Criteria [19]. A sensitivity analysis
was performed using the forward and backward stepwise
method based on Akaike Information Criteria methods to
select the risk factors. The analysis used the entire cohort af-
ter removing duplicated records due to multiple readmis-
sions as well as the subgroups of SG, RYGB, and BPDDS
separately to examine the association between the use of
an IOLT and the outcomes of interest. The statistical analysis
was performed using R version 3.5.0 (Vienna, Austria).
Results
Data for a total of 265,309 bariatric patients were
analyzed. Of these patients, 184,538 (69.6%) underwent
SG, 78,686 (29.7%) underwent RYGB, and 2085
(0.8%) underwent BPDDS. IOLT was performed in
81.9% of the patients. Overall, A/SL within 30 days
occurred in .28% of all patients. The rates of leakage af-
ter SG, RYGB, and BPDDS were .24%, .33%, and
1.77%, respectively. The incidence of A/SL outcomes
in relation to patient characteristics and operative
variables are shown in Table 1. Table 2 presents the as-
sociation of IOLT and clinical outcomes of interest.
Thirty-day mortality rates in patients with a leak and
30-day leak-related mortality were .1% and .004%,
respectively. Overall rates of 30-day leak-related read-
mission, reoperation, intervention, and organ/space SSI
were .19%, .18%, .13%, and .23%, respectively. There
were no significant differences between the IOLT and
non-IOLT groups after primary bariatric surgery in terms
of A/SL, 30-day mortality rate in patients with leakage,
30-day leak-related mortality, readmission, reoperation,
intervention, or organ/space SSI. Similar results were
found for SG, RYGB, and BPDDS, except for 30-day
leak-related intervention in BPDDS, which was signifi-
cantly lower in the IOLT group compared with the
non-IOLT group. Mean operative time was significantly
increased in the IOLT group compared with the non-
IOLT group for all bariatric surgeries and for each type
of the procedure (Table 2). Mean differences (95% con-
fidence interval [CI]) of operative times for the entire
cohort and the subgroups of SG, RYGB, and BPDDS
were 19.2 minutes (95% CI 18.7–19.5), 9.5 minutes
(95% CI 9.1–9.8), 11.9 minutes (95% CI 10.6–13.3),
and 21.2 minutes (95% CI 13.8–28.5), respectively.
Factors associated with postoperative leaks
Crude odds ratios of variables associated with postopera-
tive leaks are shown in the Supplementary Table 1. Table 3
presents the adjusted odds ratios of factors associated with
postoperative leaks from hierarchical variable selection.
The variables in Table 3 were included in the regression
model for the entire cohort as well as for SG and RYGB.
The bougie size and staple line reinforcement factors were
added in the model for SG. For BPDDS, only the variables
 Kamthorn Yolsuriyanwong et al. / Surgery for Obesity and Related Diseases 15 (2019) 1530–1540 1533

Table 1
Patient characteristics and operative variables by leak status*
Characteristics Patients with leakage Patients without leakage P value
n 5 746 n 5 264,563
No. % No. %
Demographic characteristics
Sex ,.001
Female 549 73.6 209,479 79.2
Male 197 26.4 55,084 20.8
Age, yr (mean 6 SD) 46.0 6 11.9 44.6 6 12.0 .001
Age interval, yr .004
10–20 11 1.5 2750 1.0
21–30 65 8.7 30,078 11.4
31–40 160 21.4 68,275 25.8
41–50 233 31.2 76,307 28.8
51–60 178 23.9 58,174 22.0
61–70 93 12.5 26,325 10.0
.70 6 .8 2640 1.0
Missing 0 0 14 0
Ethnicity .002
White 600 80.4 195,496 73.9
Black 92 12.3 45,921 17.4
Asian 4 .5 1261 .5
Other (American Indian or Alaska native, Native Hawaiian 5 .7 1777 .7
or other Pacific Islander)
Unknown and missing 45 6.0 20,108 7.6
Hispanic .727
Yes 91 12.2 32,747 12.4
No 600 80.4 206,288 78.0
Unknown 55 7.4 25,528 9.6
BMI, kg/m2 (mean 6 SD) 46.1 6 8.6 45.6 6 8.1 .168
BMI category, kg/m2 .237
,35 29 3.89 8614 3.26
35–39.9 152 20.38 57,487 21.73
40–49.9 357 47.86 134,274 50.75
50–59.9 155 20.78 47,917 18.11
60–69.9 37 4.96 11,140 4.21
70 10 1.34 3197 1.21
Missing 6 .80 1934 .73
American Society of Anesthesiologists Class .001
1–2 142 19.0 60,760 23.0
3 557 74.7 192,856 72.9
4–5 42 5.6 9719 3.7
Missing 5 .7 1228 .5
Co-morbidities
Gastroesophageal reflux disease 277 37.1 82,707 31.3 ,.001
History of myocardial infarction 14 1.9 3526 1.3 .257
History of PCI/PTCA 24 3.2 5677 2.1 .059
Previous cardiac surgery 15 2.0 3006 1.1 .038
Hyperlipidemia 224 30.0 65,359 24.7 ,.001
Hypertension 403 54.0 129,668 49.0 .007
History of deep vein thrombosis 14 1.9 4212 1.6 .636
Venous stasis 14 1.9 2853 1.1 .054
Dialysis 1 .1 744 .3 .68
Renal insufficiency 9 1.2 1704 .6 .092
Therapeutic anticoagulation 26 3.5 6450 2.4 .083
Diabetes .004
Insulin dependent 81 10.9 23,779 9.0
Noninsulin dependent 160 21.4 47,310 17.9
Smoker 97 13.0 23,282 8.8 ,.001
Dependent functional status .004
Partially dependent 11 1.5 1810 .7
Totally dependent 6 .8 930 .4
(continued on next page )
1534 Kamthorn Yolsuriyanwong et al. / Surgery for Obesity and Related Diseases 15 (2019) 1530–1540

Table 1 (continued )
Characteristics Patients with leakage Patients without leakage P value
n 5 746 n 5 264,563
No. % No. %
Chronic obstructive pulmonary disease 23 3.1 4642 1.8 .009
Oxygen dependent 7 .9 1877 .7 .60
History of pulmonary embolism 9 1.2 3001 1.1 .99
Sleep apnea 305 40.9 101,057 38.2 .141
Chronic steroid use 24 3.2 4205 1.6 ,.001
Inferior vena cava filter 11 1.5 2363 .9 .136
Laboratory tests
Albumin, g/dL (mean 6 SD) 4.03 6 .40 4.05 6 .39 .235
Albumin level, g/dL .253
,2.5 1 .13 158 .06
2.5–2.9 1 .13 455 .17
3.0–3.4 43 5.76 11,150 4.21
3.5 524 70.24 181,827 68.73
Missing 177 23.73 70,973 26.83
Hematocrit, % (mean 6 SD) 41.5 6 4.1 40.9 6 3.8 ,.001
Hematocrit level, % .419
,25.0 2 .27 384 .15
25.0–29.9 3 .40 611 .23
30.0 661 88.61 235,829 89.14
Missing 80 10.72 27,739 10.48
Operative variables
Type of procedure ,.001
SG 450 60.3 184,088 69.6
RYGB 259 34.7 78,427 29.6
BPDDS 37 5.0 2048 .8
First assist training level .772
None 104 13.9 38,566 14.6
Physician assistant or nurse practitioner 279 37.4 101,224 38.3
Resident 141 18.9 45,957 17.4
Minimally invasive surgery fellow 73 9.8 23,340 8.8
Attending—weight loss surgeon 108 14.5 40,641 15.4
Attending—other 41 5.5 14,835 5.6
Surgical approach ,.001
Conventional laparoscopic 636 85.3 236,750 89.5
Robotic-assisted 80 10.7 17,804 6.7
Laparoscopic-assisted 29 3.9 9243 3.5
Other (NOTES, hand-assisted and single incision) 1 .1 766 .3
Intraoperative anastomosis checked .133
Endoscopic method 192 25.7 60,434 22.8
Nonendoscopic method (naso/orogastric tube insertion) 431 57.8 156,168 59.0
Drain placed 205 27.5 59,199 22.4 ,.001
Swallow study .177
Routine 281 37.7 99,347 37.6
Selective 14 1.9 3050 1.2
Operative time, min (mean 6 SD)
All procedures 105.4 6 56.7 89.5 6 47.5 ,.001
SG 84.5 6 44.2 75.7 6 36.5 ,.001
RYGB 132.2 6 56.0 119.2 6 53.2 ,.001
BPDDS 165.3 6 70.0 156.7 6 73.7 .461
Error data (,30 min), n, % 17 2.3 6209 2.3
Technique for SG (n 5 184,538) 450 .2 184,088 99.8
Bougie size, Fr (mean 6 SD) 36.7 6 2.9 36.8 6 3.1 .539
Bougie size interval, Fr .963
,36 119 26.4 48,938 26.6
36–40 297 66.0 122,361 66.5
41–45 11 2.4 4024 2.2
46–50 2 .4 1056 .6
50 0 .0 132 .1
Error data (,26Fr and .60Fr) 21 4.7 7577 4.1
(continued on next page )
 Kamthorn Yolsuriyanwong et al. / Surgery for Obesity and Related Diseases 15 (2019) 1530–1540 1535

Table 1 (continued )
Characteristics Patients with leakage Patients without leakage P value
n 5 746 n 5 264,563
No. % No. %
Pyloric distance, cm (mean 6 SD) 4.4 6 1.9 4.5 6 1.6 .309
Pyloric distance interval, cm .146
,2.0 41 9.1 11,559 6.3
2.0–2.9 14 3.1 5567 3.0
3.0–3.9 42 9.3 15,203 8.3
4.0–4.9 97 21.6 41,687 22.6
5.0–5.9 134 29.8 61,047 33.2
6.0 121 26.9 48,476 26.3
Error data (.10.0 cm) 1 .2 549 .3
Reinforcement .539
SLR only 244 54.3 99,983 54.3
OS only 49 10.9 17,282 9.4
SLR and OS 62 13.8 24,268 13.2
No 94 20.9 42,555 23.1
Missing 1 .2 0 0
SD 5 standard deviation; BMI 5 body mass index; PCI/PTCA 5 percutaneous coronary interventions/percutaneous transluminal coronary angioplasty;
SG 5 sleeve gastrectomy; RYGB 5 Roux-en-Y gastric bypass; BPDDS 5 biliopancreatic diversion with duodenal switch; NOTES 5 natural orifice translu-
minal endoscopic surgery; SLR 5 staple line reinforcement; OS 5 oversewn.
* Data presented as number and percentage unless otherwise specified.

of anastomosis checked, sex, smoker, hyperlipidemia, dia-
betes mellitus, gastroesophageal reflux disease, operative
time, and drain usage were used in the regression model
due to the small number of patients.
Multivariable logistic regression analysis for
postoperative outcomes
Table 4 summarizes the results of the multivariable lo-
gistic regression analysis and shows the adjusted odds
ratios of each outcome conferred by an IOLT. The regres-
sion model for all bariatric procedures as well as for SG,
RYGB, and BPDDS included the same variables described
previously. An IOLT had no significant effect on A/SL in
the primary analysis, which included the entire cohort.
Similar results were found for SG, RYGB, and BPDDS.
An IOLT also had no relationship to secondary outcomes,
which included 30-day mortality rate in patients with
a leak, 30-day leak-related readmission, reoperation,

Table 2
Association of intraoperative leak test and clinical outcomes*
Outcomes All procedures SG RYGB BPDDS
n 5 265,309 n 5 184,538 n 5 78,686 n 5 2,085
Test No test P Test No test P Test No test P Test No test P
n 5 217,225 n 5 48,084 value n 5 142,447 n 5 42,091 value n 5 73,128 n 5 5558 value n 5 1650 n 5 435 value
Primary outcome
Anastomotic/staple 623 (.29) 123 (.26) .25 354 (.25) 96 (.23) .46 240 (.33) 19 (.34) .86 29 (1.76) 8 (1.84) .91
line leakage
Secondary outcomes
30-d mortality in 208 (.10) 45 (.09) .89 103 (.07) 32 (.08) .80 96 (.13) 11 (.20) .19 9 (.55) 2 (.46) 1.00
patients with leak
30-d leak-related 8 (.004) 0 (0) .36 3 (.002) 0 (0) .84 3 (.004) 0 (0) .19 2 (.12) 0 (0) 1.00
mortality
30-d leak-related 408 (.19) 91 (.19) .95 279 (.20) 83 (.20) .96 119 (.16) 6 (.11) .32 10 (.61) 2 (.46) .72
readmission
30-d leak-related 385 (.18) 70 (.15) .13 186 (.13) 51 (.12) .64 172 (.24) 13 (.23) .99 27 (1.64) 6 (1.38) .70
reoperation
30-d leak-related 282 (.13) 65 (.14) .77 199 (.14) 52 (.12) .43 80 (.11) 8 (.14) .46 3 (.18) 5 (1.15) .01
intervention
Organ/space SSI 491 (.23) 95 (.20) .23 222 (.16) 67 (.16) .88 241 (.33) 21 (.38) .55 28 (1.70) 7 (1.61) .90
Operative time, min 93.0 6 48.9 73.8 6 36.7 ,.01 77.9 6 37.8 68.4 6 30.6 ,.01 120.1 6 53.5 108.2 6 48.2 ,.01 161.2 6 74.5 140.0 6 68.0 ,.01
(mean 6 SD)
SG 5 sleeve gastrectomy; RYGB 5 Roux-en-Y gastric bypass; BPDDS 5 biliopancreatic diversion with duodenal switch; SSI 5 surgical site; SD 5 standard
deviation.
* Data presented as n (%) unless otherwise specified.
1536 Kamthorn Yolsuriyanwong et al. / Surgery for Obesity and Related Diseases 15 (2019) 1530–1540

Table 3
Adjusted odds ratios of factors associated with postoperative leakage from hierarchical variable selection
Factors All procedures SG RYGB BPDDS*
n 5 265,309 n 5 184,538 n 5 78,686 n 5 2085
OR (95% CI) P value OR (95% CI) P value OR (95% CI) P value OR (95% CI) P value
Demographic characteristics
Sex
Male versus female (Ref) 1.14 (.93–1.40) .198 .95 (.71–1.25) .702 1.41 (1.00–1.96) .047 1.30 (.63–2.58) .461
Age interval, yr
10–20 2.42 (1.10–4.76) .017 3.33 (1.32–7.40) .006 1.68 (.26–5.98) .494 N/A
21–30 Ref Ref Ref N/A
31–40 1.13 (.80–1.62) .515 1.28 (.82–2.08) .296 .84 (.46–1.61) .583 N/A
41–50 1.36 (.97–1.94) .084 1.50 (.97–2.42) .078 1.19 (.68–2.22) .558 N/A
51–60 1.29 (.90–1.89) .167 1.33 (.83–2.19) .245 1.37 (.76–2.60) .314 N/A
61–70 1.51 (1.00–2.29) .051 1.06 (.60–1.90) .839 2.33 (1.24–4.56) .011 N/A
.70 .66 (.16–1.84) .490 .65 (.10–2.26) .569 1.46 (.23–5.42) .622 N/A
Ethnicity
White Ref Ref Ref N/A
Black .68 (.52–.87) .003 .56 (.39–.78) .001 .92 (.59–1.38) .709 N/A
Asian 1.47 (.45–3.47) .445 .60 (.03–2.66) .606 2.33 (.38–7.47) .239 N/A
Other .95 (.29–2.23) .914 .94 (.16–2.94) .933 .62 (.03–2.76) .630 N/A
BMI category, kg/m2
,35 1.04 (.60–1.69) .872 1.13 (.60–1.97) .689 1.16 (.44–2.56) .742 N/A
35–39.9 Ref Ref Ref N/A
40–49.9 1.03 (.82–1.30) .801 1.00 (.76–1.33) .994 .97 (.66–1.45) .861 N/A
50–59.9 1.03 (.78–1.36) .849 .89 (.61–1.30) .557 1.08 (.68–1.72) .746 N/A
60–69.9 .96 (.60–1.48) .871 1.13 (.60–1.95) .691 1.14 (.53–2.26) .714 N/A
70 1.29 (.62–2.37) .455 1.86 (.77–3.82) .122 1.20 (.29–3.41) .761 N/A
Co-morbidities (no co-morbidity, Ref)
Gastroesophageal reflux disease 1.21 (1.01–1.45) .041 1.30 (1.02–1.66) .034 1.02 (.75–1.38) .888 1.47 (.71–2.92) .283
Hyperlipidemia 1.02 (.82–1.27) .848 1.09 (.82–1.46) .539 .74 (.51–1.07) .111 2.54 (1.18–5.30) .014
Renal insufficiency 1.85 (.83–3.56) .094 1.91 (.58–4.65) .209 2.22 (.66–5.52) .129 N/A
Diabetes mellitus
Insulin dependent 1.01 (.74–1.36) .941 1.09 (.67–1.70) .705 1.07 (.67–1.64) .780 .62 (.22–1.57) .342
Noninsulin dependent 1.09 (.87–1.37) .438 1.28 (.94–1.71) .108 1.05 (.71–1.52) .791 0.36 (.10–95) .063
Smoker 1.43 (1.09–1.85) .008 1.58 (1.12–2.19) .007 1.16 (.67–1.87) .568 1.54 (.52–3.72) .382
Chronic obstructive pulmonary disease 1.40 (.83–2.21) .174 1.41 (.66–2.63) .325 1.28 (.53–2.60) .531 N/A
Chronic steroid use 2.33 (1.45–3.55) ,.001 1.73 (.85–3.10) .093 2.75 (1.23–5.32) .006 N/A
Laboratory tests N/A
Albumin level, g/dL N/A
,2.5 2.03 (.11–9.17) .483 3.79 (0.21–17.26) .187 N/A N/A
2.5–2.9 .71 (.04–3.17) .729 N/A 1.69 (.09–7.80) .606 N/A
3.0–3.4 1.45 (1.04–1.98) .021 1.65 (1.07–2.44) .017 1.26 (.70–2.08) .409 N/A
3.5 Ref Ref Ref N/A
Operative variables
Type of procedure
SG Ref N/A N/A N/A
RYGB 1.24 (.88–1.74) .223 N/A N/A N/A
BPDDS 7.98 (3.41–17.89) ,.001 N/A N/A N/A
Surgical approach
Laparoscopic Ref Ref Ref N/A
Robotic assisted 1.43 (1.07–1.88) .013 1.59 (1.07–2.28) .016 .91 (.50–1.54) .752 N/A
Laparoscopic assisted 1.19 (.74–1.82) .440 1.30 (.71–2.19) .354 1.04 (.41–2.16) .926 N/A
Other .57 (.03–2.52) .570 N/A N/A N/A
Operative time per 10-min increases 1.03 (1.00–1.05) .017 1.03 (1.00–1.05) .047 1.03 (1.00–1.05) .020 1.02 (.97–1.06) .446
Drain placed
Yes versus no (Ref) 1.20 (.98–1.45) .072 1.18 (.89–1.53) .239 1.17 (.86–1.59) .312 1.65 (.80–3.46) .177
Anastomosis checked
No Ref Ref Ref Ref
Endoscopic method .94 (.71–1.26) .790 1.15 (.82–1.62) .409 .87 (.49–1.56) .643 1.46 (.47–4.50) .508
Nonendoscopic method 1.04 (.81–1.33) .551 .96 (.72–1.30) .799 .78 (.45–1.35) .375 1.01 (.44–2.52) .983
(Naso/orograstric tube insertion)
(continued on next page )
 Kamthorn Yolsuriyanwong et al. / Surgery for Obesity and Related Diseases 15 (2019) 1530–1540 1537

Table 3 (continued )
Factors All procedures SG RYGB BPDDS*
n 5 265,309 n 5 184,538 n 5 78,686 n 5 2085
OR (95% CI) P value OR (95% CI) P value OR (95% CI) P value OR (95% CI) P value
Additional factors only for SG
Bougie size
,36.0 N/A Ref N/A N/A
36–40 N/A 1.12 (.87–1.45) .400 N/A N/A
41–45 N/A .98 (.41–1.99) .968 N/A N/A
46–50 N/A 1.23 (.07–5.59) .839 N/A N/A
.50 N/A N/A N/A N/A
Reinforcement
No N/A Ref N/A N/A
SLR only N/A 1.02 (.77–1.37) .890 N/A N/A
OS only N/A 1.27 (.84–1.90) .239 N/A N/A
SLR and OS N/A 1.14 (.77–1.67) .900 N/A N/A
OR 5 odds ration; CI 5 confidence interval; SG 5 sleeve gastrectomy; RYGB 5 Roux-en-Y gastric bypass; BPDDS5 biliopancreatic diversion with
duodenal switch; N/A 5 not applicable; BMI 5 body mass index; SLR 5 staple line reinforcement; OS 5 oversewn.
* For BPDDS, variables including anastomosis checked, sex, smoker, hyperlipidemia, diabetes mellitus, gastroesophageal reflux disease, operative time, and
drain placed were used in the regression model.

intervention, and organ/space SSI for all procedures, SG,
RYGB, and BPDDS.
Type of intraoperative leak test
Of the patients who underwent IOLT (81.9%; 217,225 of
265,309), endoscopy was used for 27.9% of the IOLTs and
nonendoscopic methods (naso/orogastric tube insertion)
were used for the remaining patients (72.1%). In patients
who underwent SG, endoscopic IOLT was used for 20.9%
and nonendoscopic IOLT for 56.3%. In RYGB patients,
the endoscopic method was used for IOLT in 27.6%, and
in 65.3% nonendoscopic methods were used for the IOLTs.
In patients who underwent BPDDS, IOLT was performed by
the endoscopic method in 19.8%, and in 59.4% a nonendo-
scopic method was used. There were no statistical differ-
ences in the rates of postoperative A/SL among patients
who underwent IOLT using either the endoscopic method
or the nonendoscopic method in the entire cohort or in pa-
tients who had SG, RYGB, or BPDDS. Neither endoscopic
IOLT nor nonendoscopic IOLT had any association with
postoperative leaks in any type of procedure (Table 3).
Mean operative time was significantly higher in the endo-
scopic group compared with the nonendoscopic group for
all bariatric surgeries (98.5 6 51.4 min versus 90.8 6
47.7 min), SG (82.4 6 39.9 min versus 76.2 6 36.9 min),
RYGB (124.2 6 55.6 min versus 118.4 6 52.5 min), and
BPDDS (197.5 6 81.1 min versus 149.1 6 67.9 min).
The mean differences (95% CI) of operative times for the
entire cohort and the subgroups of SG, RYGB, and BPDDS
were 7.6 minutes (95% CI 7.2–8.1), 6.2 minutes (95% CI
5.75–6.68), 5.8 minutes (95% CI 5.0–6.7), and 48.4 minutes
(95% CI 39.7–57.1), respectively.
Discussion
In this study, .80% of patients underwent IOLT, which
indicated that IOLT was used as a routine intervention dur-
ing bariatric surgery among MBSAQIP participating cen-
ters. IOLT may be useful in detecting leaks that can be

Table 4
Adjusted odds ratios of clinical outcomes with intraoperative leak test
Outcomes All procedures n 5 265,309 SG n 5 184,538 RYGB n 5 78,686 BPDDS n 5 2085
OR (95% CI) P value OR (95% CI) P value OR (95% CI) P value OR (95% CI) P value
Primary outcome
Anastomotic/staple line leakage .96 (.75–1.22) .73 .99 (.74–1.30) .92 .81 (.47–1.37) .43 1.38 (.46–4.12) .57
Secondary outcomes
30-d mortality in patients with leak .73 (.49–1.09) .13 .84 (.51–1.37) .48 .54 (.25–1.14) .11 .03 (0–.94) .31
30-d leak-related mortality N/A N/A N/A N/A N/A N/A N/A N/A
30-d leak-related readmission 1.01 (.76–1.34) .96 .97 (.71–1.31) .83 1.26 (.51–3.12) .62 2.62 (.22–31.48) .45
30-d leak-related reoperation .88 (.65–1.19) .40 .87 (.61–1.26) .47 .76 (.42–1.38) .37 1.27 (.38–4.19) .70
30-d leak-related intervention .92 (.65–1.29) .14 .97 (.66–1.42) .88 .86 (.34–2.16) .75 .59 (.03–10.23) .72
Organ/space SSI .87 (.66–1.15) .32 .87 (.62–1.22) .42 .72 (.43–1.20) .21 1.93 (.55–6.74) .31
OR 5 odds ratio; CI 5 confidence interval; SG 5 sleeve gastrectomy; RYGB 5 Roux-en-Y gastric bypass; BPDDS 5 biliopancreatic diversion with
duodenal switch; N/A 5 not applicable; SSI, surgical site infection.
1538 Kamthorn Yolsuriyanwong et al. / Surgery for Obesity and Related Diseases 15 (2019) 1530–1540
subsequently repaired during the index procedure and then
rechecked and found to be negative. However, those data
are not available as part of the PUF. Several studies have re-
ported on the benefits of IOLT in the prevention of technical
defect–related leaks during bariatric surgery. Ramanathan
et al. [20] reported that the intraoperative leak rate was
10% for 182 patients who underwent RYGB. The intraoper-
ative repair of these air leaks resulted in a postoperative leak
rate of 3.8%, or a 60% reduction of clinically significant
leaks. Champion et al. [21] detected intraoperative air leaks
in 29 of 743 patients (3.9%) who underwent RYGB with
intraoperative repair. Of these patients, only 1 patient
(3.4%) had a postoperative leak. Similar findings of
reducing postoperative leaks or of no postoperative leaks af-
ter routine IOLT in RYGB patients have been reported
[12,22,23]. A large population study from Haddad et al.
[13] reported an intraoperative leak rate of 3.5% (80 of
2308 RYGB patients). Of the patients with intraoperative
leaks, 46 underwent intraoperative repair. Postoperative
clinical leaks were detected in 4 of the patients (.2%), 2 of
whom had an initial intraoperative leak. A recent prospec-
tive randomized controlled trial evaluated the use of intrao-
perative endoscopy for leak detection after RYGB (50
patients with IOLT versus 50 patients without IOLT). The
IOLT group had a statistically significantly lower rate of
anastomotic leak (0% versus 8%) and a lower need for reop-
eration (0% versus 8%) [11]. Furthermore, the benefit of
IOLT is not limited to the prevention of postoperative
leak. Several studies have shown the benefits of looking at
anastomotic or staple line bleeding or stenosis during the
procedure [10,24]. This additional information may lead
to alteration of the surgical anatomy including a revision if
the stenosis is significant. Bleeding can be controlled either
endoscopically or with the use of extraluminal maneuvers
such as suturing or the placement of mechanical clips.
However, many other reports have concluded that IOLT
has no correlation with operative leak and was not associ-
ated with a decrease in the incidence of postoperative leaks.
Sethi et al. [14] reported cases where IOLT was performed
in 85.7% of 1550 SG patients and found no positive intrao-
perative results, but 1% in the IOLT group developed a post-
operative leak. There was no difference in the postoperative
leak rate between those who had undergone IOLT and those
who had not, and there was no association between postop-
erative leaks and IOLT. Similarly, Bingham et al. [17] found
that routine use of an IOLT did not reduce, but may increase,
the incidence of postoperative leak after SG. Later, Bingham
et al. [15] also reported a multicenter study of 4284 patients
who underwent SG and found that routine IOLT had very
poor sensitivity (8.7%). The authors concluded that the
use of IOLT was not associated with a decrease in the inci-
dence of postoperative leaks and that routine IOLT had no
benefit over selective leak testing. Kirby et al. [16] reported
on the routine use of the methylene blue dye test in 924 pa-
tients (75.3% for RYGB, 24.3% for SG, and 9.2% for
revisional surgery). They found positive intraoperative re-
sults in 2 patients, but postoperative leaks were found in 5
patients who had a negative IOLT. They also found no rela-
tionship between positive IOLT and anastomotic leak. A
systematic review and meta-analysis by Parikh et al. [3]
found that the performance of a leak test did not seem to
affect leak rate. Moreover, some studies have reported that
IOLT was a risk factor for postoperative leakage [25,26].
In addition, IOLT using either endoscopy or naso/
orogastric tube insertion carried the risk of complications
that included gastrointestinal tract injury or perforation,
aspiration, and anaphylaxis from the methylene blue dye
[12,13,27,28].
Unfortunately, the MBSAQIP data set does not provide
information regarding the technique of leak test or, more
importantly, intraoperative results of the leak test, repair
strategies, or whether the test was performed either
routinely or selectively. Therefore, this study could not
evaluate the sensitivity and specificity of IOLT or the ben-
efits from intraoperative repair of the leak site. This study
has shown that the rates of postoperative A/SL, 30-day
mortality in patients with leak, 30-day leak-related mortal-
ity, readmission, reoperation, intervention, and organ/space
SSI were not different among patients who had or had not
undergone IOLT during overall primary bariatric surgeries,
SG, or RYGB. Moreover, IOLT was not associated with
postoperative A/SL and leak-related outcomes in this study.
These results support the 2015 American Society for Meta-
bolic and Bariatric Surgery position statement on preven-
tion, detection, and treatment of gastrointestinal leak after
SG and RYGB. In summary, that position statement stated
that IOLT may be useful to detect leaks that can be
repaired during the procedure but that these techniques
have not been reported to decrease the risk of leak after
surgery [9]. However, Alizadeh et al. [26], using the
2015 database from MBSAQIP, reported the rate of gastro-
intestinal leak was significantly higher in patients with
IOLT versus without IOLT (.8 % versus .4 %, P , .01)
and that IOLT was associated with higher postoperative
leak (adjusted odds ratio 1.41; 95% CI 1.14–1.76; P 5 .02).
The difference in the results between our study and the Ali-
zadeh et al. study may be due to the following explanations.
First, the definition of A/SL in our study did not include pa-
tients with a drain present .30 days and organ/space SSI.
Second, in addition to excluding revisional and emergent
cases, we also excluded patients with previous obesity or
foregut surgery and those with open approach and
conversion-to-open surgeries. Third, we analyzed the data
from year 2015 and 2016 MBSAQIP PUF. And fourth, the
statistical analysis and variables in the regression model
were different. However, we did find that the rate of 30-day
leak-related intervention in BPDDS was significantly lower
in the IOLT group compared with the non-IOLT group.
Our results did show that the overall mean operative time
increased by 19.1 minutes (9.5 min for SG, 11.9 min for
 Kamthorn Yolsuriyanwong et al. / Surgery for Obesity and Related Diseases 15 (2019) 1530–1540
RYGB, and 21.2 min for BPDDS) when a leak test was per-
formed. This longer operative time can result in an increased
risk of postoperative complications, cost, and resource utili-
zation [14,25,29]. Similarly, Sethi et al. [14] reported an
operative time increase of 7.6 minutes in patients with
IOLT after SG with an increased total cost of US$855.37.
Approximately one third of patients with IOLT had the
test performed by the endoscopic method. However, this
result may be an underestimation if the surgeon used other
codes or failed to enter an endoscopy code because of no
reimbursement benefit. Moreover, we cannot assume why
an endoscopy was performed in patients that had an endos-
copy. The purposes of endoscopy might be for hemostasis,
evaluation of stenosis, or for other endoscopic interventions
rather than for leak test. Sethi et al. [14] reported similar re-
sults to those in our study. They reported that the majority of
patients (64%) had naso/orogastric tube with methylene
blue for the IOLT, and they found no difference in postoper-
ative leak rates (1% versus 1%) between endoscopy with air
leak test and naso/orogastric tube with methylene blue test.
The advantages of using endoscopic IOLT over naso/orogas-
tric tube are the ability to perform hemostasis intraluminally
and to detect stenosis [10,24]. However, endoscopy requires
specific equipment and personnel, leading to additional
costs. These can be lower if a naso/orogastric tube is used.
In addition, our study showed that the endoscopic
technique had an increased mean operative time of 7.6
minutes compared with a nonendoscopic method.
The IOLT is designed to detect anastomosis or staple line
defects intraoperatively and is useful only for immediate
repair of the defects. Due to rare technical error or device/
staple failure, the benefit from IOLT is minimal. Even
though adverse events from IOLT using either endoscopy
or naso/orogastric tube insertion are rare, these events can
be life-threatening conditions. In our study, IOLT did not
show any benefit with regard to postoperative A/SL and
leak-related morbidities and mortalities. However, this
intervention also did not show any harm. Therefore, we sug-
gest that IOLT may be of benefit and selectively performed
in patients with a high risk of leakage, including those un-
dergoing revisional surgery and those with intraoperative
complications, and in the case of surgeons in the early stages
of their learning curve. Last but not least, endoscopic IOLT
may be used for other purposes such as to evaluate bleeding
and/or to detect stenosis.
Strengths and limitations
The MBSAQIP database is a high-quality, validated data
source. This data set was prospectively abstracted by meta-
bolic and bariatric surgical clinical reviewers who were
trained for quality improvement and outcome reporting.
Data from accredited centers were also audited by the
MBSAQIP, and centers that had a disagreement rate .5%
were not included in the MBSAQIP Semiannual Report
1539
and were required to be re-audited. Due to the low rate of
postoperative leak, it would be very difficult to conduct a
randomized control or cohort study with enough power to
study the factors associated with leakages. Using this
nationwide database, large numbers of patients were
included, providing adequate statistical power.
There are several limitations in this study. The accuracy of
coding and data input was limited. There were some missing
data and errors in the data that could bias the findings even
though the data abstraction was performed by well-trained
clinical reviewers. The data from the MBSAQIP were
collected for only 30 days postoperatively. Any event, such
as late leak, reoperation, readmission, intervention, or mor-
tality, that occurred after 30 days was not taken into account.
Therefore, the rate of postoperative leak and leak-related
morbidities and mortality may be underestimated. In addi-
tion, the database did not provide information on the tech-
niques of IOLT, the results of IOLT, and whether an IOLT
was performed routinely or selectively. Without these data,
we cannot interpret the accuracy of the tests and the benefits
from intraoperative repair of the leak site. More importantly,
the database did not provide information regarding surgeon
volume and experience. These factors can affect postopera-
tive outcomes. Furthermore, if patients developed adverse
events and went to another hospital, it was difficult to capture
those cases in this database. Moreover, the results from this
study cannot be used to represent hospitals outside the
MBSAQIP or in low-volume centers.
With the low incidences of postoperative A/SL in patients
with IOLT (.29%) and without IOLT (.26%), a larger sample
would be required to show a significant difference. More-
over, due to the relatively low number of patients and leak
events with BPDDS, the results of the BPDDS groups
should be carefully interpreted. This study did not exclude
patients with other or concurrent operations. The addition
of other procedures increases operative time and complex-
ities of the operation and possibly increases the risk of post-
operative complications. However, Liu et al. [30] reported
1.2% concurrent operations (6087 of 513,167) without
increased risk for adverse perioperative outcomes compared
with patients without concurrent operations.
Conclusions
The incidence of postoperative A/SL and leak-related
morbidities and mortality after bariatric surgery was low.
This study provided no evidence of either benefit or harm
from IOLT in patients who underwent SG, RYGB, or
BPDDS in terms of postoperative A/SL and leak-related
morbidities and mortality. The postoperative leak-related
complication rates after endoscopic and nonendoscopic
IOLT were comparable. However, IOLTs require more oper-
ative time and equipment resources. Furthermore, these
techniques may have their own complications. Therefore,
IOLT may be of benefit when used selectively in high-risk
1540 Kamthorn Yolsuriyanwong et al. / Surgery for Obesity and Related Diseases 15 (2019) 1530–1540
patients, when used by surgeons or teams early in their
learning curve, or when endoscopy can be of benefit for con-
cerns of hemostasis or stenosis.
Acknowledgments
The authors would like to thank Glenn Shingledecker in
the Office of International Affairs, Faculty of Medicine,
Prince of Songkla University, for proofreading and language
support.
Disclosures
The authors have no commercial associations that might
be a conflict of interest in relation to this article.
Supplementary materials
Supplementary material associated with this article can
be found, in the online version, at https://doi.org/10.1016/
j.soard.2019.06.008.
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