Prevention of Umbilical Port-site Hernia After Laparoscopic Cholecystectomy Using a Prosthetic Mesh Versus Simple Suture

Phase 3

Completed

• Conditions: Port-site Hernia

• Registration Number: NCT01802229
• Lead Sponsor: Hospital General Universitario Elche

Brief Summary

The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of umbilical port site.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-02
• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-02-28
• Last Update Submitted: 2013-02-28
• Study First Posted: 2013-03-01
• Last Update Posted: 2013-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Age > 65 years
• BMI > 30 Kg/m2
• Diabetes mellitus
• Lung disease
• Elective laparoscopic cholecystectomy

Exclusion Criteria

• Umbilical hernia
• Previous laparotomy
• Conversion to open procedure
• Loss during the follow up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of port-site hernia	12 months	Comparison of incidence of port-site hernia between patiensts with and without prophylactic mesh placement

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	12 months	Evaluation of different pain perception in patients with and without prophylactic mesh placement, determined in the postoperative course and at 1, 6 and 12 months after surgery

Trial Locations

Locations (1)

Hospital general Universitario de Elche; 🇪🇸 Elche, Alicante, Spain