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

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ClinicalTrials.gov Identifier: NCT01459471
Recruitment Status : Completed
First Posted : October 25, 2011
Last Update Posted : October 25, 2011
Sponsor:
Information provided by (Responsible Party):
Paolo Gentileschi, University of Rome Tor Vergata

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
Complication of Surgical Procedure Leak; Blood Procedure: Bariatric surgery Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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 : April 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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. [ Time Frame: six months ]
    a comparison between three techniques of staple line reinforcement. The number of adverse events will be registered and analyzed



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Ages Eligible for Study:   28 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Morbidly obese patients waiting for sleeve gastrectomy

Exclusion Criteria:

  • BMI<35 Kg/m2,
  • Important comorbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459471


Sponsors and Collaborators
University of Rome Tor Vergata
Investigators
Study Director: Paolo Gentileschi, MD University of Tor Vergata, Rome, Italy

Responsible Party: Paolo Gentileschi, Professor, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT01459471     History of Changes
Other Study ID Numbers: SEND-11-0905
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: October 2011