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

NCT ID: NCT01802229

Last Updated: 2013-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Port-site Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Suture

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

Group Type ACTIVE_COMPARATOR

Fascial suture

Intervention Type PROCEDURE

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

Prophylactic mesh

Umbilical port-site closure with mesh placement

Group Type EXPERIMENTAL

Prophylactic mesh placement

Intervention Type PROCEDURE

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

Interventions

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Prophylactic mesh placement

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

Intervention Type PROCEDURE

Fascial suture

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital general Universitario de Elche

Elche, Alicante, Spain

Site Status

Countries

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Spain

Other Identifiers

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2013-002

Identifier Type: -

Identifier Source: org_study_id

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