Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

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

Further study details as provided by Paolo Gentileschi, 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 ]
    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).

Ages Eligible for Study:   28 Years to 59 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01459471

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

Responsible Party: Paolo Gentileschi, Professor, University of Rome Tor Vergata Identifier: NCT01459471     History of Changes
Other Study ID Numbers: SEND-11-0905
Study First Received: October 4, 2011
Last Updated: October 21, 2011 processed this record on May 25, 2017