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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05987787
Other study ID # 8
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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