Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy

Not Applicable

• Conditions: Laparoscopic Sleeve Gastrectomy
• Interventions: Procedure: Staple line suturing reinforcement methods - Plication and Over-sewing

• Registration Number: NCT04323696
• Lead Sponsor: Universiti Putra Malaysia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-26
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-15
• Study Start: 2020-07-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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'

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Over-sewing	Staple line suturing reinforcement methods - Plication and Over-sewing	Patients under over-sewing arm are subjected to staple line reinforcement using over-sewing method
Plication	Staple line suturing reinforcement methods - Plication and Over-sewing	Patients under over-sewing arm are subjected to staple line reinforcement using plication method

Primary Outcome Measures

Name	Time	Method
Immediate and early post-operative complication	0-30 days	Staple line bleeding

Secondary Outcome Measures

Name	Time	Method
Immediate and early post-operative complication	0-30 days	Re-admission and re-operation