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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Erhan Aysan, SB Istanbul Education and Research Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01578538
First Posted: April 17, 2012
Last Update Posted: April 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Erhan Aysan, SB Istanbul Education and Research Hospital
  Purpose
Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective complications.

Condition Intervention
Hernia Procedure: inguinal hernia repair

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesh Used Repairs in Emergency Abdominal Wall Hernias

Resource links provided by NLM:


Further study details as provided by Erhan Aysan, SB Istanbul Education and Research Hospital:

Primary Outcome Measures:
  • wound infection [ Time Frame: six months ]
    surgical wound infection is the primary outcome measure of this trial


Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578538


Locations
Turkey
Bezmialem Vakif University Recruiting
Istanbul, Marmara, Turkey, 34543
Contact: adnan yuksel, prof    904531700    ayuksel@bezmialem.edu.tr   
Principal Investigator: erhan aysan, prof         
Sponsors and Collaborators
SB Istanbul Education and Research Hospital
  More Information

Responsible Party: Erhan Aysan, prof. dr., SB Istanbul Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01578538     History of Changes
Other Study ID Numbers: herni
travma & emergency surgery ( Registry Identifier: mcs )
First Submitted: April 13, 2012
First Posted: April 17, 2012
Last Update Posted: April 17, 2012
Last Verified: April 2012

Keywords provided by Erhan Aysan, SB Istanbul Education and Research Hospital:
hernia, abdominal, strangulation, emergency, wall

Additional relevant MeSH terms:
Emergencies
Hernia
Hernia, Ventral
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical
Hernia, Abdominal