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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01802229

Enrollment

106

Registered

2013-03-01

Start date

2011-01-31

Completion date

2012-12-31

Last updated

2013-03-01

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

Conditions

Port-site Hernia

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.

Interventions

PROCEDUREProphylactic mesh placement

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

PROCEDUREFascial suture

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of port-site hernia	12 months	Comparison of incidence of port-site hernia between patiensts with and without prophylactic mesh placement

Secondary

Measure	Time frame	Description
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

Countries

Spain

Outcome results

None listed

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