- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00820131
Chronic Pain After Inguinal Hernia Repair (GRIP-ME)
A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Feldkirch, Austria
- LKH Feldkirch, Dept. of Surgery
-
Linz, Austria
- Hospital Barmherzige Schwestern
-
Mistelbach, Austria
- LK Weinviertel Mistelbach, Surgical Department
-
Vienna, Austria, 1170
- KH Göttlicher Heiland
-
Vienna, Austria
- KFJ Hospital, Dept. of Surgery
-
Vienna, Austria
- Medical University of Vienna, Dept. of Surgery
-
Wiener Neustadt, Austria
- KH Wiener Neustadt, Surgical Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
inguinal hernia repair using a selfgrip mesh
|
Active Comparator: 2
|
inguinal hernia repair using a lightweight mesh with suture fixation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
chronic pain
Time Frame: 3 months, 15 months
|
3 months, 15 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
morbidity
Time Frame: 3 months, 15 months
|
3 months, 15 months
|
recurrence rate
Time Frame: 3 months and 15 months
|
3 months and 15 months
|
quality of life
Time Frame: 3 months and 15 months
|
3 months and 15 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerhard Prager, MD, Medical University of Vienna
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK MUW 613/2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
-
Assiut UniversityNot yet recruiting
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Istanbul UniversityCompletedLow Back Pain, Mechanical, Biofeedback, Pain, Chronic
-
Apurano Pharmaceuticals GmbHRecruitingPain | Lower Back Pain | Back Pain | Chronic Pain | Pain, Chronic | Chronic Pain Syndrome | Pain Syndrome | Lower Back Pain ChronicGermany
Clinical Trials on selfgrip mesh
-
Blokhin's Russian Cancer Research CenterRecruitingRectal Cancer | Surgery | Neoplasms Malignant | Hernia IncisionalRussian Federation
-
Istanbul Training and Research HospitalRecruitingHernia, InguinalTurkey
-
Helsinki University Central HospitalActive, not recruitingInguinal Hernia | SurgeryFinland
-
Assiut UniversityUnknown
-
National University Hospital, SingaporeUnknown
-
University Hospital, GhentCompleted
-
Aesculap AGCompletedIncisional Hernia RepairGermany
-
Mansoura UniversityCompleted
-
Kips Bay Medical, Inc.University Hospital Schleswig-HolsteinTerminatedMyocardial Ischemia | Heart Diseases | Cardiovascular Diseases | Vascular Diseases | Coronary Artery Disease | Coronary Disease | Arteriosclerosis | Arterial Occlusive DiseasesGermany