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

Hospital General Universitario Elche106 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

106

Conditions

Port-site Hernia

Interventions

Prophylactic mesh placementPROCEDURE

Placement of a Omega 3 mesh, fixed to the border of the fascia

Fascial suturePROCEDURE

The port-site hole is closed with simple suture of the fascia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital general Universitario de Elche

Elche, Alicante, Spain

Outcomes

Primary Outcomes

Incidence of port-site hernia

Comparison of incidence of port-site hernia between patiensts with and without prophylactic mesh placement

Time frame: 12 months

Secondary Outcomes

Postoperative pain

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

Time frame: 12 months

Data from ClinicalTrials.gov

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