Completed
Prevention of Umbilical Port-site Hernia After Laparoscopic Cholecystectomy Using a Prosthetic Mesh Versus Simple Suture
What is being tested
Fascial suture
+ Prophylactic mesh placement
Procedure
Who is being recruted
From 18 to 90 Years
+9 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 3
Interventional
Study Start: January 2011
Summary
Principal SponsorHospital General Universitario Elche
Last updated: March 1, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2011
Actual date on which the first participant was enrolled.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.
Principal SponsorHospital General Universitario Elche
Last updated: March 1, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
106 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 90 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
5 inclusion criteria required to participate
Age > 65 years
BMI > 30 Kg/m2
Diabetes mellitus
Elective laparoscopic cholecystectomy
Show More Criteria
4 exclusion criteria prevent from participating
Conversion to open procedure
Loss during the follow up
Previous laparotomy
Umbilical hernia
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorUmbilical port-site closure with simple suture of the fascia.
Group II
ExperimentalUmbilical port-site closure with mesh placement
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Hospital general Universitario de Elche
Elche, SpainOpen Hospital general Universitario de Elche in Google MapsCompletedOne Study Center