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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paolo Gentileschi, University of Rome Tor Vergata
ClinicalTrials.gov Identifier:
NCT01459471
First received: October 4, 2011
Last updated: October 21, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention
Complication of Surgical Procedure
Leak; Blood
 Procedure: Bariatric surgery

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rome Tor Vergata:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    a comparison between three techniques of staple line reinforcement. The number of adverse events will be registered and analyzed


Enrollment: 120
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bleeding, leak, operative time Procedure: Bariatric surgery
Staple line reinforcement during sleeve gastrectomy
Other Names:
  • bariatric surgical procedure
  • gastric resection
  • steaple line reinforcement

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).

  Eligibility

Ages Eligible for Study:   28 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Morbidly obese patients waiting for sleeve gastrectomy

Exclusion Criteria:

  • BMI<35 Kg/m2,
  • Important comorbidities
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459471

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

No publications provided

Responsible Party: Paolo Gentileschi, Professor, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT01459471     History of Changes
Other Study ID Numbers: SEND-11-0905
Study First Received: October 4, 2011
Last Updated: October 21, 2011
Health Authority: Italy: Ethics Committee

ClinicalTrials.gov processed this record on May 16, 2013