Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy

NCT04323696 | Unknown

• 1 other identifier: 53293
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Laparoscopic Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Immediate and early post-operative complication

  Staple line bleeding

  0-30 days

Secondary Outcomes (2)

• Immediate and early post-operative complication

  0-30 days

• Immediate and early post-operative complication

  0-30 days

Study Arms (2)

Over-sewing

OTHER

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

Plication

OTHER

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

Procedure: Staple line suturing reinforcement methods - Plication and Over-sewing

Interventions

Staple line suturing reinforcement methods - Plication and Over-sewing 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).

Over-sewing; Plication

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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'

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr

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

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: July 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 15, 2020

Record last verified: 2020-05