Suture Reinforcement to Reduce the Leak Rate After Sleeve Gastrectomy

Completed

• Conditions: Obesity, Morbid; Bleeding; Bariatric Surgery Candidate; Leak, Anastomotic
• Interventions: Procedure: laparoscopic sleeve gastrectomy without suture reinforcement; Procedure: laparoscopic sleeve gastrectomy with suture reinforcement

• Registration Number: NCT05987787
• Lead Sponsor: University of Foggia

Brief Summary

Staple line reinforcement (SLR) has been suggested as a mean of reducing the risk of sleeve leakage or bleeding. The aim of this study is to analyze if the suture reinforcement can be used to reduce the leakage rate after sleeve gastrectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-07-01
• Study First Submitted: 2023-07-26
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-03
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• BMI>40 kg/m2
• BMI>35 kg/m2with at least one associated major comorbidity

Exclusion Criteria

• secondary obesity due to endocrine and psychological disorders
• patients under antiaggregant and anticoagulant therapy
• re-do surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese patients underwent laparoscopic sleeve gastrectomy without suture reinforcement	laparoscopic sleeve gastrectomy without suture reinforcement	Laparoscopic sleeve gastrectomy without staple line reinforcement.
Obese patients underwent laparoscopic sleeve gastrectomy with suture reinforcement	laparoscopic sleeve gastrectomy with suture reinforcement	Laparoscopic sleeve gastrectomy running seromuscular stitches at the proximal third of the stapled line using unidirectional 2/0 barbed sutures to invaginate the staple line completely.

Primary Outcome Measures

Name	Time	Method
the importance of staple line reinforcement	During Surgery	the differences of operative time between two groups

Trial Locations

Locations (1)

University of Foggia; 🇮🇹 Foggia, Italy