Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh

October 29, 2012 updated by: MARCELO A. BELTRAN, M.D., Cirujanos la Serena

Randomized Study of Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh Versus On-lay Mesh Repair

The intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the "gold-standard" for the repair of incisional hernia. However no studies have convincingly proven that this approach is better than the on-lay repair.

The authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Iv Region
      • La Serena, Iv Region, Chile, IV REGION
        • Hospital de La Serena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2)
  • First repair
  • Older than 35 years of age and younger than 75 years of age
  • Both genders
  • Any BMI
  • Only upper abdominal midline incisional hernias (supraumbilical)
  • Patients submitted only to elective repair

Exclusion Criteria:

  • Recurrent incisional hernia
  • Emergency surgery
  • Hernias with a diameter higher than 5 cm or more than 25 cm2 of area
  • Lower midline abdominal incisional hernias
  • Other hernias rather than midline incisional hernias
  • Non-incisional hernias

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1. Intraperitoneal repair
Patients with incisional hernia, 5 cm in diameter or with an area of 25 cm2, submitted to elective surgery
Device: Implant of a prosthetic mesh
A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study
Active Comparator: 2. On-Lay repair
Patients with incisional hernia, with a diameter of 5 cm or an area of 25 cm2, submitted to elective surgery
Device: Implant of a prosthetic mesh
A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Long-term recurrence
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Short-term complications
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cirujanos la Serena

Investigators

  • Principal Investigator: MARCELO A BELTRAN, M.D., Hospital de La Serena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

April 30, 2009

First Submitted That Met QC Criteria

April 30, 2009

First Posted (Estimate)

May 1, 2009

Study Record Updates

Last Update Posted (Estimate)

October 31, 2012

Last Update Submitted That Met QC Criteria

October 29, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLS-2904009-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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