Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy

Comparison of Staple Line Suturing Reinforcement Methods in Laparoscopic Sleeve Gastrectomy

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.

Study Overview

• Status: Unknown
• Conditions: Laparoscopic Sleeve Gastrectomy
• Intervention / Treatment: Procedure: Staple line suturing reinforcement methods - Plication and Over-sewing

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Over-sewing; 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; 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).
Other: Plication; Patients under over-sewing arm are subjected to staple line reinforcement using plication method	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 53293

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No