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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
Konya Meram State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incisional Hernia

Eligibility Criteria

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

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

First Posted
December 8, 2014
Last Updated
December 9, 2014
Sponsor
Konya Meram State Hospital
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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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