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NCT03051919 Clinical Trial

Reinforcement Method in Laparoscopic Sleeve Gastrectomy

Laparoscopic Sleeve Gastrectomy Clinical Trial

Official title:
Staple Line Reinforcement Methods in Laparoscopic Sleeve Gastrectomy: Comparison of Burst Pressures and Leaks

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03051919
Other study ID # FSMTRH
Secondary ID
Status Completed
Phase N/A
First received April 1, 2015
Last updated February 18, 2017
Start date March 2014
Est. completion date October 2014

Study information
Verified date February 2017
Source Fatih Sultan Mehmet Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Laparoscopic sleeve gastrectomy is a technically simple popular bariatric operation with acceptable results. Leaks can occur in long staple lines; therefore, variable reinforcement methods are used.

Description:

The investigator compared non-reinforced stapling with three staple line reinforcement methods (suturing, absorbable buttressing material and fibrin glue) in laparoscopic sleeve gastrectomy.

The resected stomach specimens were treated in the same manner of reinforcement as used in the surgeries of the corresponding patients and then insufflated until a burst occurred. The burst pressures of the resected stomach specimens and postoperative events of the patients were recorded.

Recruitment information / eligibility
Status Completed
Enrollment 118
Est. completion date October 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- body mass index >40 kg/m2

Exclusion Criteria:

- disruption of the resected stomach during extraction from the abdomen.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• observation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary assessing prevalence of leaks among different reinforcement methods observation 3 months
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