Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial

Complication of Surgical Procedure Clinical Trial

Official title:

Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459471
• Other study ID #: SEND-11-0905
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: October 21, 2011
• Start date: April 2010
• Est. completion date: September 2010

Study information

• Verified date: October 2011
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative complications. Staple line reinforcement (SLR) is strongly advocated.

Description:

The aim of this study was to prospectively and randomly compare three different techniques of SLR during LSG: oversewing (group A), buttressed transection with a polyglycolide acid and trimethylene carbonate (group B) and staple-line roofing with a gelatin fibrin matrix (group C).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Years to 59 Years

Eligibility

Inclusion Criteria:

• Morbidly obese patients waiting for sleeve gastrectomy

Exclusion Criteria:

• BMI<35 Kg/m2,

• Important comorbidities

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Leak; Blood

Intervention

Procedure:
• Bariatric surgery
Staple line reinforcement during sleeve gastrectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of staple line reinforcement during laparoscopic sleeve gastrectomy by measuring the number of adverse effects, i.e. bleeding and leaks.	a comparison between three techniques of staple line reinforcement. The number of adverse events will be registered and analyzed	six months	No