Predisposing Factors for Chronic Postherniotomy Pain

January 20, 2009 updated by: Rigshospitalet, Denmark

Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

455

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hørsholm, Denmark
        • Ambulatory Surgical Clinic, Hørshom Sygehus
  • Germany
      • Stuttgart, Germany
        • Marienhospital, Viszeralchirurgie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Neurological disease
  • Diabetes with late stage complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of chronic pain
Time Frame: 6 months postoperatively
6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in sensory function
Time Frame: 6 months
6 months
Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Baxter Healthcare Corporation
Aesculap AG

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

January 22, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • (KF) 01 294867

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.

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