Suture Reinforcement to Reduce the Leak Rate After Sleeve Gastrectomy

Staple-line Suture Reinforcement: Could it Help Contain the Leak?

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.

Study Overview

• Status: Completed
• Conditions: Bleeding; Obesity, Morbid; Bariatric Surgery Candidate; Leak, Anastomotic
• Intervention / Treatment: Procedure: laparoscopic sleeve gastrectomy with suture reinforcement; Procedure: laparoscopic sleeve gastrectomy without suture reinforcement

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Italy
  • Foggia, Italy, 71122
    • University of Foggia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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 .

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 without suture reinforcement; Laparoscopic sleeve gastrectomy without staple line reinforcement.	Procedure: laparoscopic sleeve gastrectomy without suture reinforcement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Foggia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Anastomotic Leak; Obesity, Morbid
• Other Study ID Numbers: 8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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