Chronic Pain After Inguinal Hernia Repair (GRIP-ME)

• ClinicalTrials.gov Identifier: NCT00820131
• Recruitment Status: Completed
• First Posted: January 9, 2009
• Last Update Posted: December 9, 2014
• Sponsor: Medical University of Vienna
• Information provided by: Medical University of Vienna

Tracking Information

• First Submitted Date: January 8, 2009
• First Posted Date: January 9, 2009
• Last Update Posted Date: December 9, 2014
• Study Start Date: January 2008
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 8, 2009): chronic pain [ Time Frame: 3 months, 15 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 24, 2011)

• morbidity [ Time Frame: 3 months, 15 months ]
• recurrence rate [ Time Frame: 3 months and 15 months ]
• quality of life [ Time Frame: 3 months and 15 months ]

• Original Secondary Outcome Measures (submitted: January 8, 2009): morbidity, recurrence rate, quality of life, duration [ Time Frame: 3 months, 15 months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Chronic Pain After Inguinal Hernia Repair
• Official Title: A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh

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:

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Inguinal Hernia
• Chronic Pain

Intervention

• Procedure: selfgrip mesh
  inguinal hernia repair using a selfgrip mesh
• Procedure: lightweight mesh with suture fixation
  inguinal hernia repair using a lightweight mesh with suture fixation

Study Arms

• Experimental: 1
  Intervention: Procedure: selfgrip mesh
• Active Comparator: 2
  Intervention: Procedure: lightweight mesh with suture fixation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: January 8, 2009): 250
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT00820131
• Other Study ID Numbers: EK MUW 613/2007
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gerhard Prager, MD, Medical University of Vienna
• Study Sponsor: Medical University of Vienna
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gerhard Prager, MD; Medical University of Vienna

• PRS Account: Medical University of Vienna
• Verification Date: January 2009