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Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy

NCT04323696 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-05-15

No results posted yet for this study

Summary

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.

Conditions

  • Laparoscopic Sleeve Gastrectomy

Interventions

PROCEDURE

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).

Sponsors & Collaborators

  • Universiti Putra Malaysia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-06-30
Completion
2022-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04323696 on ClinicalTrials.gov