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

U

University of Rome Tor Vergata

Status

Completed

Conditions

Complication of Surgical Procedure
Leak; Blood

Treatments

Procedure: Bariatric surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01459471
SEND-11-0905

Details and patient eligibility

About

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

Full 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).

Enrollment

120 patients

Sex

All

Ages

28 to 59 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Morbidly obese patients waiting for sleeve gastrectomy

Exclusion criteria

  • BMI<35 Kg/m2,
  • Important comorbidities

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

bleeding, leak, operative time
Experimental group
Treatment:
Procedure: Bariatric surgery

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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