Suture Reinforcement to Reduce the Leak Rate After Sleeve Gastrectomy

NCT05987787 | Completed

• 1 other identifier: 8
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Obesity, Morbid; Leak, Anastomotic; Bleeding

Outcome Measures

Primary Outcomes (2)

• the importance of staple line reinforcement

  reduction of the leak rate in the suture group

  1 year

• the importance of staple line reinforcement

  the differences of operative time between two groups

  During Surgery

Study Arms (2)

Obese patients underwent 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.

Procedure: laparoscopic sleeve gastrectomy with suture reinforcement

Obese patients underwent laparoscopic sleeve gastrectomy without suture reinforcement

Laparoscopic sleeve gastrectomy without staple line reinforcement.

Procedure: laparoscopic sleeve gastrectomy without suture reinforcement

Interventions

laparoscopic sleeve gastrectomy without suture reinforcement PROCEDURE

The procedure begins by dissecting the small branches of the gastroepiploic arch 6 cm from the pylorus. The dissection continues along the great curvature of the stomach, remaining very close to the gastric wall, up to the short gastric vessels which are also dissected. The stomach is then raised to expose its posterior wall and the adhesions are lysed. His angle is fully mobilized and the left diaphragmatic pillar exposed. The gastric tubule is created on the guide of a 40 F Bugie using mechanical suturing machines with charges of different thickness depending on the thickness of the gastric wall. At this point the bougie is removed and the resected stomach is extracted from the abdomen through the mesogastric access.

Obese patients underwent laparoscopic sleeve gastrectomy without suture reinforcement

laparoscopic sleeve gastrectomy with suture reinforcement PROCEDURE

The procedure begins by dissecting the small branches of the gastroepiploic arch 6 cm from the pylorus. The dissection continues along the great curvature of the stomach, remaining very close to the gastric wall, up to the short gastric vessels which are also dissected. The stomach is then raised to expose its posterior wall and the adhesions are lysed. His angle is fully mobilized and the left diaphragmatic pillar exposed. The gastric tubule is created on the guide of a 40 F Bugie using mechanical suturing machines with charges of different thickness depending on the thickness of the gastric wall. At this point the bougie is removed and the resected stomach is extracted from the abdomen through the mesogastric access. At this point, it is applied running seromuscular stitches at the proximal third of the stapled line using unidirectional 2/0 barbed sutures to invaginate the staple line completely.

Obese patients underwent laparoscopic sleeve gastrectomy with suture reinforcement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity or BMI≥40kg/m2, age ≥ 18 years. Before surgery, patients underwent a standardized psychological and physical evaluation which includes blood chemistry tests, chest x-rays, electrocardiogram and cardiological examinations, nutritional evaluation, esophagogastroduodenoscopy, spirometry and psychiatric evaluation .

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Foggia: lead

Study Sites (1)

University of Foggia

Foggia, 71122, Italy

Location

MeSH Terms

Conditions

Obesity, Morbid; Anastomotic Leak; Hemorrhage

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)