Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy

Laparoscopic Sleeve Gastrectomy Clinical Trial

Official title:

Comparison of Staple Line Suturing Reinforcement Methods in Laparoscopic Sleeve Gastrectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04323696
• Other study ID #: 53293
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2020
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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'

Related Conditions & MeSH terms

• Laparoscopic Sleeve Gastrectomy

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate and early post-operative complication	Staple line bleeding	0-30 days
Secondary	Immediate and early post-operative complication	Staple line leak	0-30 days
Secondary	Immediate and early post-operative complication	Re-admission and re-operation	0-30 days