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

Primary Purpose

Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
inguinal hernia repair
Sponsored by
SB Istanbul Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring hernia, abdominal, strangulation, emergency, wall

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakif UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

mesh used repair

nonmesh

Arm Description

mesh used hernia repair will be perform

nonmesh hernia repair techniques will be used

Outcomes

Primary Outcome Measures

wound infection
surgical wound infection is the primary outcome measure of this trial

Secondary Outcome Measures

Full Information

First Posted
April 13, 2012
Last Updated
April 16, 2012
Sponsor
SB Istanbul Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01578538
Brief Title
Safety of Mesh Used Repairs in Emergency Abdominal Wall Hernias. Prospective Randomized Multicenter Trial
Acronym
hernia
Official Title
Mesh Used Repairs in Emergency Abdominal Wall Hernias
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SB Istanbul Education and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
Keywords
hernia, abdominal, strangulation, emergency, wall

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mesh used repair
Arm Type
Active Comparator
Arm Description
mesh used hernia repair will be perform
Arm Title
nonmesh
Arm Type
Active Comparator
Arm Description
nonmesh hernia repair techniques will be used
Intervention Type
Procedure
Intervention Name(s)
inguinal hernia repair
Intervention Description
strangulated hernias will be repaired surgically
Primary Outcome Measure Information:
Title
wound infection
Description
surgical wound infection is the primary outcome measure of this trial
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older than 16 years old, Strangulated abdominal wall hernia No any contrindications to operation Exclusion Criteria: Younger than 16 years old, Non-strangulated abdominal wall hernis Any causes of contrindications to operation
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
State/Province
Marmara
ZIP/Postal Code
34543
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
adnan yuksel, prof
Phone
904531700
Email
ayuksel@bezmialem.edu.tr
First Name & Middle Initial & Last Name & Degree
erhan aysan, prof

12. IPD Sharing Statement

Learn more about this trial

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

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