Chronic Pain After Inguinal Hernia Repair (GRIP-ME)
Primary Purpose
Inguinal Hernia, Chronic Pain
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
selfgrip mesh
lightweight mesh with suture fixation
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia
Eligibility Criteria
Inclusion Criteria:
- primary unilateral inguinal hernia
- 18 years and older
Exclusion Criteria:
- bilateral hernia
- recurrent hernia
- incarcerated hernia
- malignant disease within the last 5 years
- not able to understand the questionaire
Sites / Locations
- LKH Feldkirch, Dept. of Surgery
- Hospital Barmherzige Schwestern
- LK Weinviertel Mistelbach, Surgical Department
- KH Göttlicher Heiland
- KFJ Hospital, Dept. of Surgery
- Medical University of Vienna, Dept. of Surgery
- KH Wiener Neustadt, Surgical Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
chronic pain
Secondary Outcome Measures
morbidity
recurrence rate
quality of life
Full Information
NCT ID
NCT00820131
First Posted
January 8, 2009
Last Updated
December 8, 2014
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00820131
Brief Title
Chronic Pain After Inguinal Hernia Repair
Acronym
GRIP-ME
Official Title
A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
5. Study Description
Brief Summary
Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain.
A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased.
Two techniques of inguinal hernia repair will be evaluated:
open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)
open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation)
Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
selfgrip mesh
Intervention Description
inguinal hernia repair using a selfgrip mesh
Intervention Type
Procedure
Intervention Name(s)
lightweight mesh with suture fixation
Intervention Description
inguinal hernia repair using a lightweight mesh with suture fixation
Primary Outcome Measure Information:
Title
chronic pain
Time Frame
3 months, 15 months
Secondary Outcome Measure Information:
Title
morbidity
Time Frame
3 months, 15 months
Title
recurrence rate
Time Frame
3 months and 15 months
Title
quality of life
Time Frame
3 months and 15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary unilateral inguinal hernia
18 years and older
Exclusion Criteria:
bilateral hernia
recurrent hernia
incarcerated hernia
malignant disease within the last 5 years
not able to understand the questionaire
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Prager, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
LKH Feldkirch, Dept. of Surgery
City
Feldkirch
Country
Austria
Facility Name
Hospital Barmherzige Schwestern
City
Linz
Country
Austria
Facility Name
LK Weinviertel Mistelbach, Surgical Department
City
Mistelbach
Country
Austria
Facility Name
KH Göttlicher Heiland
City
Vienna
ZIP/Postal Code
1170
Country
Austria
Facility Name
KFJ Hospital, Dept. of Surgery
City
Vienna
Country
Austria
Facility Name
Medical University of Vienna, Dept. of Surgery
City
Vienna
Country
Austria
Facility Name
KH Wiener Neustadt, Surgical Department
City
Wiener Neustadt
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Chronic Pain After Inguinal Hernia Repair
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