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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01459471

Enrollment

120

Registered

2011-10-25

Start date

2010-04-30

Completion date

2010-09-30

Last updated

2011-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Surgical Procedure, Leak; Blood

Brief summary

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

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).

Interventions

PROCEDUREBariatric surgery

Staple line reinforcement during sleeve gastrectomy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

28 Years to 59 Years

Healthy volunteers

Inclusion criteria

* Morbidly obese patients waiting for sleeve gastrectomy

Exclusion criteria

* BMI\<35 Kg/m2, * Important comorbidities

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026