Back to resultsRandomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Hernia repair
Hernia repair
Hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia
Eligibility Criteria
Inclusion Criteria:
- 18-75 years
- unilateral primary hernia
- open surgery
Exclusion Criteria:
- Recurrent Hernia
- Bilateral Hernia
- laparoscopic surgery
- Female
Sites / Locations
- Ersta Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Lichtenstein
Arm Description
Hernia repair with lichtenstein propylene mesh
Outcomes
Primary Outcome Measures
postoperatively pain
Visual analog scale (VAS)
Secondary Outcome Measures
Quality of life
SF36
frequency of recurrencies
check patients journal
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01699971
Brief Title
Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair
Official Title
Randomized Controlled Study Comparing Three Different Techniques for Open
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lichtenstein
Arm Type
Active Comparator
Arm Description
Hernia repair with lichtenstein propylene mesh
Intervention Type
Procedure
Intervention Name(s)
Hernia repair
Intervention Description
Hernia repair admodum Lichtenstein with polypropylene mesh
Intervention Type
Procedure
Intervention Name(s)
Hernia repair
Intervention Description
Hernia repair with Ultra Pro Hernia System (UHS)
Intervention Type
Procedure
Intervention Name(s)
Hernia repair
Intervention Description
Hernia repair with Prolene Hernia System(PHS)
Primary Outcome Measure Information:
Title
postoperatively pain
Description
Visual analog scale (VAS)
Time Frame
Postoperative 36 month
Secondary Outcome Measure Information:
Title
Quality of life
Description
SF36
Time Frame
36 month postoperative
Title
frequency of recurrencies
Description
check patients journal
Time Frame
postopertive 36 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-75 years
unilateral primary hernia
open surgery
Exclusion Criteria:
Recurrent Hernia
Bilateral Hernia
laparoscopic surgery
Female
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Thorell, Assoc Prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ersta Hospital
City
Stockholm
ZIP/Postal Code
116 91
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair
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