Suture Reinforcement to Reduce the Leak Rate After Sleeve Gastrectomy

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05987787
• Other study ID #: 8
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: University of Foggia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 1, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	University of Foggia	Foggia

Sponsors (1)

Lead Sponsor	Collaborator
University of Foggia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the importance of staple line reinforcement	reduction of the leak rate in the suture group	1 year
Primary	the importance of staple line reinforcement	the differences of operative time between two groups	During Surgery