Skip to main content
OpenTrials
Completed

NCT Number: NCT01802229

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Port-site Hernia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital general Universitario de Elche

Elche, Alicante, 03203, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic mesh placement

Procedure

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

Fascial suture

Procedure

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

Primary outcomes

  1. Incidence of port-site hernia

    Time frame: 12 months

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

Secondary outcomes

  1. Postoperative pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 1, 2013
Registry last updated
Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.