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

This study is currently recruiting participants.
Verified April 2012 by SB Istanbul Education and Research Hospital
Sponsor:
Information provided by (Responsible Party):
Erhan Aysan, SB Istanbul Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT01578538
First received: April 13, 2012
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mesh Used Repairs in Emergency Abdominal Wall Hernias

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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

Primary Outcome Measures:
  • wound infection [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 13, 2012
Last Updated: April 16, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013