Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-06-30

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.

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Detailed Description

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Conditions

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Laparoscopic Sleeve Gastrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All patients who underwent laparoscopic sleeve gastrectomy from March 2020 till February 2021 will be included

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

This is a single blinded randomisation whereby the patient is not aware on the staple-line suturing reinforcement used. Suturing reinforcement of the staple-line is our standard of care in all laparoscopic sleeve gastrectomy patients

Study Groups

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Over-sewing

Patients under over-sewing arm are subjected to staple line reinforcement using over-sewing method

Group Type OTHER

Staple line suturing reinforcement methods - Plication and Over-sewing

Intervention Type PROCEDURE

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).

Plication

Patients under over-sewing arm are subjected to staple line reinforcement using plication method

Group Type OTHER

Staple line suturing reinforcement methods - Plication and Over-sewing

Intervention Type PROCEDURE

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).

Interventions

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Staple line suturing reinforcement methods - Plication and Over-sewing

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).

Intervention Type PROCEDURE

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

1. Age \< 18 or \> 65
2. BMI \< 35 and \> 60 kg/m2
3. American Society of Anesthesiologists (ASA) score \> 3
4. Concurrent surgical procedure including:

1. ventral hernia repair
2. cholecystectomy
3. hiatal hernia repair with posterior cruroplasty
4. extensive lysis of adhesions
5. other procedures that mandate addition of 'trocar(s)' or 'feeding tube'

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No