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Predisposing Factors for Chronic Postherniotomy Pain

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ClinicalTrials.gov Identifier: NCT00649142
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : January 22, 2009
Sponsor:
Collaborators:
Aesculap AG
Baxter Healthcare Corporation
Information provided by:
Rigshospitalet, Denmark

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Chronic Postherniotomy Pain Procedure: Open sutured mesh repair Procedure: Laparoscopic mesh glue fixation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 455 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain
Study Start Date : January 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of chronic pain [ Time Frame: 6 months postoperatively ]

Secondary Outcome Measures :
  1. Changes in sensory function [ Time Frame: 6 months ]
  2. Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors [ Time Frame: 6 months ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: September 2008

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