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

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Port-site Hernia

Treatments: Procedure: Prophylactic mesh placement; Procedure: Fascial suture

Study type: Interventional

Funder types: Other

Identifiers

NCT01802229

2013-002

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Suture

Active Comparator group

Description:

Umbilical port-site closure with simple suture of the fascia.

Treatment:

Procedure: Fascial suture

Prophylactic mesh

Experimental group

Description:

Umbilical port-site closure with mesh placement

Treatment:

Procedure: Prophylactic mesh placement