Suture Reinforcement to Reduce the Leak Rate After Sleeve Gastrectomy

Sponsor

University of Foggia (Other)

Overall Status

Completed

CT.gov ID

NCT05987787

Collaborator

(none)

Enrollment

Location

17.9

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery Candidate Obesity, Morbid Leak, Anastomotic Bleeding	Procedure: laparoscopic sleeve gastrectomy without suture reinforcement Procedure: laparoscopic sleeve gastrectomy with suture reinforcement

Study Design

Study Type:

Observational

Actual Enrollment :

33 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

the importance of staple line reinforcement [1 year]
reduction of the leak rate in the suture group
the importance of staple line reinforcement [During Surgery]
the differences of operative time between two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Foggia	Foggia		Italy	71122

Sponsors and Collaborators

University of Foggia

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol - Aug 2, 2023

More Information

Publications

None provided.

Responsible Party:

Giovanna Pavone, Medical doctor, University of Foggia

ClinicalTrials.gov Identifier:

NCT05987787

Other Study ID Numbers:

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity, Morbid

Anastomotic Leak

Study Results

No Results Posted as of Aug 14, 2023