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

Primary Purpose

Port-site Hernia

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Prophylactic mesh placement

Fascial suture

About this trial

This is an interventional prevention trial for Port-site Hernia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital general Universitario de Elche

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Suture

Prophylactic mesh

Arm Description

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

Umbilical port-site closure with mesh placement

Outcomes

Primary Outcome Measures

Incidence of port-site hernia

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

Secondary Outcome Measures

Postoperative pain

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

Full Information

NCT ID

NCT01802229

First Posted

February 27, 2013

Last Updated

February 28, 2013

Sponsor

Hospital General Universitario Elche

1. Study Identification

Unique Protocol Identification Number

NCT01802229

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital General Universitario Elche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Port-site Hernia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Suture

Arm Type

Active Comparator

Arm Description

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

Arm Title

Prophylactic mesh

Arm Type

Experimental

Arm Description

Umbilical port-site closure with mesh placement

Intervention Type

Procedure

Intervention Name(s)

Prophylactic mesh placement

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Fascial suture

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of port-site hernia

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Postoperative pain

Description

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Hospital general Universitario de Elche

City

Elche

State/Province

Alicante

ZIP/Postal Code

03203

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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