JOURNAL CLUB

Presented by : Dr.Mithun

Guided by : Dr.
 Journal - proper
TITLE

Prophylactic Mesh vs Suture in the

Closure of the Umbilical Trocar Site after
Laparoscopic Cholecystectomy in High-
Risk Patients for Incisional Hernia. A
Randomized Clinical Trial
 AIM
• The aim was to evaluate whether closure with an
intraperitoneal prophylactic mesh of the umbilical port site
after laparoscopic cholecystectomy can reduce the
incidence of TSIH in high-risk patients without increasing
surgical complications, pain, operating time, and hospital
stay.
 COURSE
• Prosthetic repair has become the standard
method for hernia repair.
• Mesh placement for the prevention of trocar
site incisional hernia (TSIH) is still a
controversial issue.
• We tested the hypothesis that closure with an
intraperitoneal prophylactic mesh of the
umbilical trocar after a laparoscopic
cholecystectomy can reduce the incidence of
a TSIH in high-risk patients.
• Several publications agree that the most frequent location of
TSIH is the umbilical port.1,3,4 This association is related to
the weaker anatomic region of the midline of the abdomen,
combined with the larger diameter of the incision at that level
and to the frequent fascia dilations needed to extract the
specimen, which also occur after laparoscopic
cholecystectomy.
• Although several techniques and devices have been
developed to minimize the risk of incisional hernia, the
incidence of TSIH varies between 0.65% and 2.8% and has
been reported at up to 6.3%, 22%, or even 37.1% in high-risk
patients with comorbidities such as obesity, diabetes mellitus,
advanced age, and chronic pulmonary disease.
• 1-6 In fact, 90% of the reported TSIH have been described in
patients with these comorbidities.
 METHODS
 STUDY DESIGN :
• We performed a prospective, randomized study (clinical
trial) on a sample of consecutive patients with risk factors
for TSIH who underwent elective laparoscopic cholecys-
tectomy as treatment for symptomatic cholelithiasis.
• We chose to study laparoscopic cholecystectomy because
of its high frequency and the reproducibility of both its
technique and results.
• The study protocol was approved by the local ethics
committee. All patients provided written informed consent.
• This study is registered with the US National Institutes of
Health clinical trials database (www.clinicaltrials. gov)
identifier: NCT 01802229.
 Inclusive criteria
• It included all consecutive patients aged between 18-
90years.
• They underwent elective laparoscopic cholecystectomy.
• They met atleast 1 of high rosk favtors of TISH i.e,
1. Obesity (body mass index !30 kg/m2),
2. Diabetes mellitus,
3. Advanced age (older than 65 years), and
4. Chronic pulmonary disease.
 Exclusive criteria
• Patients with an umbilical hernia or
midline laparotomy scar affecting the
periumbilical area.
• Patients who were converted to
laparotomy or lost to follow-up were
excluded from the statistical analysis.
Place of study: Hospital General Universitario
de Elche (Spain).

Year of publishing : March 2011 to February

2012 until Febrauary 2013

Type of study :

Sample size : 106patients

 INTERVENTION
• All patients received perioperative systemic antibiotic pro-
phylaxis with Cefuroxime 1.5 g IV, and were operated on by
surgeons with extensive experience and dedication in
abdominal wall and laparoscopic cholecystectomy
procedures.
• The umbilical fascial incision was standardized to be
transverse in all patients.
• After the patient was included in the study and the
laparoscopic cholecystectomy was completed, the removal
of the gallbladder was performed using extraction bags in
all cases.
• Closure of the incision for the umbilical trocar was
performed according to the previous randomization groups.
 GROUP A
• The method used for group A was umbilical trocar
closure by suture (3 stitches).
• Only in case of impossibility of extraction of the
specimen was the fascia slightly opened.
• In that case, the standardized closure of the
fascial defect used 4 stitches. The fourth stitch
was placed at the fascial ending where the
extension was performed.
• The material was nonabsorbable polyester (Ti-
Cron; Covidien) twisted polybutylate-coated,1 -
gauge, and a needle-shaped hook was used.
 GROUP B
• The method used for group B was umbilical trocar closure
by an intra-abdominal prosthesis using a bilaminar V-
PATCH (Atrium) polypropylene mesh coated with bio-
absorbable omega-3 oil.
• The prosthesis was introduced through the umbilical
incision into the intraperitoneal compartment.
• Correct expansion was achieved by pulling on the 2 strips
emerging from the central portion of the mesh.
• Each strip was sutured to one of the fascial edges, and
the excess was cut off.
• We have not closed the fascia in the central portion
because it would favor the fold of the prosthesis.
• Mesh diameter was standard size (6.4 cm and
the only size available at our institution) and was
fixed with absorbable suture (Vicryl; Ethicon) in
the fascia, with a braided 2-0 semi-circular
needle round tip.
• This intra- peritoneal mesh was selected to
minimize the alteration of the abdominal wall
necessary for placement of extraperitoneal
prosthesis, and because it provided better
results in terms of hernia recurrence compared
with onlay repair, which was observed both in
experience and in the literature.
 Patient assessment, follow-up, and outcomes

• After the surgery, patients were monitored in

immediate post op care and with close follow-up
for 1year
• On the day after surgery, patient’s postop pain
was assesed using a visual analogue scale from
0 (complete absence of pain) 10 (unbearable
pain).
• After the surgery, all patients received the same
schedule of analgesics (metamizol 1 g IV every 8
hours, alternating with paracetamol 1 g every 8
hours).
• At discharge, the follow-up reviews were performed in our
outpatient center at 1, 6, and 12 months after the sur-
gery, by a surgeon with extensive experience in
abdominal wall and laparoscopic cholecystectomy
procedures.
• The presence of incisional hernia was defined by a
protrusion at or near the area of the umbilical incision,
often related with pain and increasing in size with a raise
in abdominal pressure.
• The diagnosis of TISH was performed by clinical
examination, with confirmation by another surgeon.In
case of doubts, CT scan was performed for confirmation.
• Surgical site infection (SSI) was defined as the presence
of pain, heat, redness, swelling, and purulent discharge at
the surgical incision and/or positive culture within 30 days
of the operative procedure in group A and within 12
months in group B.
• Surgical site infection was evaluated during hospital stay
and weekly after discharge up to 30 days after surgery by
an epidemiology nurse blinded to the treatment.
• All SSIs were confirmed by a surgeon on the investigation
team. A culture of purulent discharge was obtained in all
patients requiring wound opening for drainage.
 Result
• A total of 106 patients were included in the study
from March 2011 to February 2012, with 53 in
group A (con- trol) and 53 in group B (mesh).
After the follow-up of 1 year, the final analysis
included 92 patients, with 45 in group B (after
the loss of 4 patients for the conversion to
laparotomy and the loss of 4 to follow-up) and 47
in group A (after the loss of 3 patients for the
conversion to laparotomy and the loss of 3 to
follow-up)
 Discussion
• Trocar site incisional hernia is the most common compli-
cation of laparoscopic surgery.
• To the best of our knowledge, this is the first random-
ized study to analyze the closure of the umbilical port site
using simple suture vs prophylactic mesh placement for
the prevention of TSIH
• In our study, we identified 17 incisional hernias (18.5%),
with 15 (16.3%) in the control group and 2 (2.2%) in the
mesh group.
• The high over- all rate of incisional hernias is due not
only to the close follow-up that was performed, but also
to the selection of high-risk patients, as the data
published in the literature do not differentiate between
patients with and without risk factors.
• The incidence of hernias in patients at risk after the placement
of mesh was reduced to 2.2%, which is within the stan- dards
established in the literature.
• For surgical technique and materials, most published series
agree that the most common location for this type of incisional
hernia is the umbilical region, which is associated with an
increased incision diameter and increased anatomical
weakness.
• For patient-dependent factors that predispose the risk for
TSIH, several authors agree that up to 90% of the TSIH
appear in patients with comorbidities;
• Most published series agree that the risk is increased by
obesity, advanced age (older than 60 or 65 years, depending
on the series), diabetes mellitus, and presence of chronic
bronchial disease.For the possible influence of wound
infection and presence of malnutrition, there are no conclusive
data, despite an association being described in the literature
• However, technical difficulty with regard to suture practice is one of the
main problems that can lead to incorrect sutures.
• When the standard technique does not ensure proper closure of the
incision, some authors consider the use of prosthetic material to be
appropriate.
• Moreno and colleagues2 and Sa ́nchez-Pernaute and colleagues
describe the possibility of placing double-sided mesh (polypro- pylene-
expanded PTFE) to ensure the correct closure of the hole, thereby
avoiding umbilical tension.
• Infection is the complication with the most severe potential impact with
regard to placement of prosthetic materials. The SSI rate at liver or
pancreas surgery varies from 2.8% to 10.2%, and patient characteristics,
including age, diabetes, and obesity, have been shown as risk factors for
SSI.
• Curiously, we observed that the complication and SSI rates, excluding
TSIH, during the follow-up, were significantly lower in the group with
mesh placement, supporting that this closure method is at least as safe
as the closure with simple suture, as reported by other authors.
• In experimental studies, the omega-3 mesh coating has been associated
with antimicrobial properties against both bacteria and viruses.
• In addition, the systemic adminis- tration of omega-3 has
been shown to reduce inflamma- tory response and
endothelial activation in critically ill patients.
• Medium-chain free fatty acids and their corre- sponding 1-
monoglycerides have been found to have a broad spectrum
of microbicidal activity against several viruses and bacteria
in vitro, including pathogens like Group A streptococci,
Group B streptococci, Staphylococcus aureus, which are
pathogens involved in prosthesis infec- tions in the
abdominal wall.
• The observed reduction in the infection rate in our group B
is an incidental finding that could be justified by the omega-
3 coating of the mesh. The main limitation to confirm this
hypothesis was the small sample size, therefore, SSI was
not the main variable investigated.
 CONCLUSION

Closure of the umbilical trocar site using a prophylactic omega-3 prosthesis

significantly reduces the incidence of TSIH, postoperative pain, and
complications of the wound in a selected group of patients with risk factors
for TSIH. No additional risk was observed in the use of the mesh regarding
local and systemic complications compared with the nonuse of mesh.
The prosthetic closure of the umbilical trocar site after laparoscopic surgery
could become the standard method for preventing TSIH in high-risk patients.
REFERENCES
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