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Predisposing Factors for Chronic Postherniotomy Pain

This study has been completed.
Sponsor:
Collaborators:
Aesculap AG
Baxter Healthcare Corporation
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00649142
First received: March 28, 2008
Last updated: January 20, 2009
Last verified: September 2008
History of Changes
  Purpose

Chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair. However no prospective study has investigated potential predisposing factors for development of pain, including genetic, psychosocial and detailed neurophysiological assessment of surgical method.

The current study will assess the above factors in a prospective study.


Condition Intervention
Chronic Postherniotomy Pain
 Procedure: Open sutured mesh repair
Procedure: Laparoscopic mesh glue fixation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Frequency of chronic pain [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in sensory function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Enrollment: 455
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Open sutured mesh repair
 Procedure: Open sutured mesh repair
Open sutured mesh repair
Active Comparator: B
Laparoscopic mesh glue fixation
 Procedure: Laparoscopic mesh glue fixation
Laparoscopic mesh glue fixation

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (>18 years)
  • Male
  • Primary unilateral groin hernia
  • Ability to use pain scales

Exclusion Criteria:

  • Neurological disease
  • Diabetes with late stage complications
  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: NCT00649142

Locations
Denmark
Ambulatory Surgical Clinic, Hørshom Sygehus
Hørsholm, Denmark
Germany
Marienhospital, Viszeralchirurgie
Stuttgart, Germany
Sponsors and Collaborators
Rigshospitalet, Denmark
Aesculap AG
Baxter Healthcare Corporation
Investigators
Study Chair: Henrik Kehlet, Professor, Ph D, M.D Rigshospitalet, Copenhagen, section for surgical pathophysiology
Principal Investigator: Reinhard Bittner, Prof. Ph D, M.D. Marienhospital Stuttgart, Viszeralchirurgie
  More Information

Publications:

Responsible Party: Henrik Kehlet, Professor, Ph D, M.D., Rigshospitalet, Section For Surgical Pathophysiology
ClinicalTrials.gov Identifier: NCT00649142     History of Changes
Other Study ID Numbers: (KF) 01 294867
Study First Received: March 28, 2008
Last Updated: January 20, 2009
Health Authority: Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
Groin hernia
Chronic postsurgical pain
open mesh repair
laparoscopic mesh glue fixation
Sensory changes after groin hernia repair

ClinicalTrials.gov processed this record on March 03, 2015