Long Term Results of Randomized Prospective Comparison of Onlay and Sublay Mesh Repair Techniques for Incisional Hernia (IH01)
Primary Purpose
Incisional Hernia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
onlay mesh hernioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Incisional Hernia
Eligibility Criteria
Inclusion Criteria:
- Incisional hernia
- Acceptance of the trial
Exclusion Criteria:
- BMI>40
- ASA score of 4
- Severe pulmonary or cardiac disease
Sites / Locations
- Konya Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Onlay
sublay
Arm Description
Onlay mesh repair group
Sublay mesh repair group
Outcomes
Primary Outcome Measures
recurrence
Secondary Outcome Measures
Full Information
NCT ID
NCT02314091
First Posted
December 8, 2014
Last Updated
December 9, 2014
Sponsor
Konya Meram State Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02314091
Brief Title
Long Term Results of Randomized Prospective Comparison of Onlay and Sublay Mesh Repair Techniques for Incisional Hernia
Acronym
IH01
Official Title
Long Term Results of Randomized Prospective Comparison of Onlay and Sublay Mesh Repair Techniques for Incisional Hernia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomised prospective comparison of onlay and sublay mesh repair techniques in incisional hernia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Onlay
Arm Type
Experimental
Arm Description
Onlay mesh repair group
Arm Title
sublay
Arm Type
Experimental
Arm Description
Sublay mesh repair group
Intervention Type
Procedure
Intervention Name(s)
onlay mesh hernioplasty
Primary Outcome Measure Information:
Title
recurrence
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Incisional hernia
Acceptance of the trial
Exclusion Criteria:
BMI>40
ASA score of 4
Severe pulmonary or cardiac disease
Facility Information:
Facility Name
Konya Training and Research Hospital
City
Konya
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Long Term Results of Randomized Prospective Comparison of Onlay and Sublay Mesh Repair Techniques for Incisional Hernia
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