Trial record 20 of 218 for:    Open Studies | "Chronic Pain"

Chronic Pain After Inguinal Hernia Repair (GRIP-ME)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00820131
First received: January 8, 2009
Last updated: February 24, 2011
Last verified: January 2009
  Purpose

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:

  1. open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)
  2. 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.


Condition Intervention Phase
Inguinal Hernia
Chronic Pain
Procedure: selfgrip mesh
Procedure: lightweight mesh with suture fixation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • chronic pain [ Time Frame: 3 months, 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • morbidity [ Time Frame: 3 months, 15 months ] [ Designated as safety issue: No ]
  • recurrence rate [ Time Frame: 3 months and 15 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3 months and 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: selfgrip mesh
inguinal hernia repair using a selfgrip mesh
Active Comparator: 2 Procedure: lightweight mesh with suture fixation
inguinal hernia repair using a lightweight mesh with suture fixation

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820131

Contacts
Contact: Gerhard Prager, MD +43 1 40400 5621 gerhard.prager@meduniwien.ac.at
Contact: Erwin Rieder, MD +43 1 40400 5621 erwin.rieder@meduniwien.ac.at

Locations
Austria
LKH Feldkirch, Dept. of Surgery Recruiting
Feldkirch, Austria
Contact: Etienne Wenzl, MD       etienne.wenzl@lkhf.at   
Sub-Investigator: Peter Tschann, MD         
Principal Investigator: Etienne Wenzl, MD         
Hospital Barmherzige Schwestern Recruiting
Linz, Austria
Contact: Martin Aufschnaiter, MD       martin.aufschnaiter@bhs.at   
Sub-Investigator: Thomas Burgstaller, MD         
Principal Investigator: Martin Aufschnaiter, MD         
LK Weinviertel Mistelbach, Surgical Department Completed
Mistelbach, Austria
Medical University of Vienna, Dept. of Surgery Completed
Vienna, Austria
KH Göttlicher Heiland Recruiting
Vienna, Austria, 1170
Contact: Viktor Grablowitz, MD         
Sub-Investigator: Alexander Butz, MD         
Principal Investigator: Viktor Grablowitz, MD         
KFJ Hospital, Dept. of Surgery Recruiting
Vienna, Austria
Contact: Josef Karner, MD       josef.karner@wienkav.at   
Principal Investigator: Sabine Thalhammer, MD         
Principal Investigator: Josef Karner, MD         
KH Wiener Neustadt, Surgical Department Recruiting
Wiener Neustadt, Austria
Contact: Friedrich Längle, MD    +43 2622 321-0    friedrich.laengle@wienerneustadt.lknoe.at   
Principal Investigator: Herwig Pokorny, MD         
Principal Investigator: Friedrich Längle, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Prager, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Prager, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00820131     History of Changes
Other Study ID Numbers: EK MUW 613/2007
Study First Received: January 8, 2009
Last Updated: February 24, 2011
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on July 24, 2014