Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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Sleeve gastrectomy (SG) involves the creation of small gastric reservoir based on lesser curvature of the stomach, which is fashioned by a longitudinal gastrectomy that preserves the antrum and pylorus together with its vagal innervation. Recently SG is viewed as a multi-purpose bariatric procedure that restricts the stomach size to induce satiety and resects fundal ghrelin-producing cells to decrease appetite. However, the risk of staple line leak and bleeding remains one of its challenging complications. Despite the fact that there are a large number of studies assessing various methods of making the staple line secure, there is to date, no consensus on which technique is best for reducing the risk of stapler line bleeding and leak. Hence, this study aims to compare staple line suturing reinforcement methods in sleeve gastrectomy using plication and over-sewing techniques.

Official Title
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Comparison of Staple Line Suturing Reinforcement Methods in Laparoscopic Sleeve Gastrectomy

Conditions
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Laparoscopic Sleeve Gastrectomy

Intervention / Treatment
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* Procedure: Staple line suturing reinforcement methods - Plication and Over-sewing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients at our Bariatric Clinic fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic sleeve gastrectomy as primary bariatric procedure will be evaluated for possible inclusion Exclusion Criteria: Age < 18 or > 65 BMI < 35 and > 60 kg/m2 American Society of Anesthesiologists (ASA) score > 3 Concurrent surgical procedure including: ventral hernia repair cholecystectomy hiatal hernia repair with posterior cruroplasty extensive lysis of adhesions other procedures that mandate addition of 'trocar(s)' or 'feeding tube'

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients who underwent laparoscopic sleeve gastrectomy from March 2020 till February 2021 will be included
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Over-sewing<br>Patients under over-sewing arm are subjected to staple line reinforcement using over-sewing method | Procedure: Staple line suturing reinforcement methods - Plication and Over-sewing<br>* Sleeve gastrectomy procedure will be performed laparoscopically. The greater curvature of the stomach will be mobilised, and stomach will be sleeved using 39F calibration tube as the stent using 5-6 60 mm-stapler reloads depending on the length and thickness of the stomach. The staple-line is then reinforced using 3/0 absorbable sutures continuously throughout the staple-line. The two staple-line suturing methods in this study include over-sewing (through and through) and plication (Lembert).<br>|
| Other: Plication<br>Patients under over-sewing arm are subjected to staple line reinforcement using plication method | Procedure: Staple line suturing reinforcement methods - Plication and Over-sewing<br>* Sleeve gastrectomy procedure will be performed laparoscopically. The greater curvature of the stomach will be mobilised, and stomach will be sleeved using 39F calibration tube as the stent using 5-6 60 mm-stapler reloads depending on the length and thickness of the stomach. The staple-line is then reinforced using 3/0 absorbable sutures continuously throughout the staple-line. The two staple-line suturing methods in this study include over-sewing (through and through) and plication (Lembert).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate and early post-operative complication | Staple line bleeding | 0-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate and early post-operative complication | Staple line leak | 0-30 days | 
| Immediate and early post-operative complication | Re-admission and re-operation | 0-30 days |