Safety of Mesh Used Repairs in Emergency Abdominal Wall Hernias. Prospective Randomized Multicenter Trial (hernia)

April 16, 2012 updated by: Erhan Aysan, SB Istanbul Education and Research Hospital

Mesh Used Repairs in Emergency Abdominal Wall Hernias

Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective complications.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Repairing of emergency (strangulated) abdominal wall hernias with mesh is controversary. Strangulated abdominal hernias are not clean surgical wounds so applying prostetic materials such as meshes are problematic. Using of prostetic materials in un-clean wounds (clean contaminated, contaminated and dirty) is not proposed. But in surgical practice meshed surgical repair techniques are using largeley. In this multicenter study we try to find the answer for emergency hernia repairs meshed or not.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

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

  • Turkey
    • Marmara
      • Istanbul, Marmara, Turkey, 34543
        • Recruiting
        • Bezmialem Vakif University
        • Principal Investigator:
          • erhan aysan, prof
        • Contact:

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Older than 16 years old,
  2. Strangulated abdominal wall hernia
  3. No any contrindications to operation

Exclusion Criteria:

  1. Younger than 16 years old,
  2. Non-strangulated abdominal wall hernis
  3. Any causes of contrindications to operation

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mesh used repair
mesh used hernia repair will be perform
Procedure: inguinal hernia repair
strangulated hernias will be repaired surgically
Active Comparator: nonmesh
nonmesh hernia repair techniques will be used
Procedure: inguinal hernia repair
strangulated hernias will be repaired surgically

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound infection
Time Frame: six months
surgical wound infection is the primary outcome measure of this trial
six months

Collaborators and Investigators

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

Sponsor

SB Istanbul Education and Research Hospital

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

February 1, 2012

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 17, 2012

Study Record Updates

Last Update Posted (Estimate)

April 17, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • herni
  • travma & emergency surgery (Registry Identifier: mcs)

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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