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

Sponsor
University of Rome Tor Vergata (Other)
Overall Status
Completed
CT.gov ID
NCT01459471
Collaborator
(none)
120
Enrollment
1
Arm
5
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bariatric surgery
 N/A

Detailed 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).

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: bleeding, leak, operative time

Procedure: Bariatric surgery
Staple line reinforcement during sleeve gastrectomy
Other Names:
  • bariatric surgical procedure
  • gastric resection
  • steaple line reinforcement

    		•

    Outcome Measures

    Primary Outcome Measures

    1. safety of staple line reinforcement during laparoscopic sleeve gastrectomy by measuring the number of adverse effects, i.e. bleeding and leaks. [six months]

      a comparison between three techniques of staple line reinforcement. The number of adverse events will be registered and analyzed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    28 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Morbidly obese patients waiting for sleeve gastrectomy
    Exclusion Criteria:

    • BMI<35 Kg/m2,

    • Important comorbidities

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Rome Tor Vergata

    Investigators

    • Study Director: Paolo Gentileschi, MD, University of Tor Vergata, Rome, Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paolo Gentileschi, Professor, University of Rome Tor Vergata
    ClinicalTrials.gov Identifier:
    NCT01459471
    Other Study ID Numbers:
    • SEND-11-0905
    First Posted:
    Oct 25, 2011
    Last Update Posted:
    Oct 25, 2011
    Last Verified:
    Oct 1, 2011

    Study Results

    No Results Posted as of Oct 25, 2011