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

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