Clinical Trials Directory

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UnknownNCT04323696

Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy

Comparison of Staple Line Suturing Reinforcement Methods in Laparoscopic Sleeve Gastrectomy

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Universiti Putra Malaysia · Academic / Other
Sex
All
Age
18 Years – 64 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREStaple line suturing reinforcement methods - Plication and Over-sewingSleeve 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).

Timeline

Start date
2020-07-01
Primary completion
2022-06-30
Completion
2022-06-30
First posted
2020-03-26
Last updated
2020-05-15

Source: ClinicalTrials.gov record NCT04323696. Inclusion in this directory is not an endorsement.