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Predisposing Factors for Chronic Postherniotomy Pain

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00649142

First Posted: April 1, 2008

Last Update Posted: January 22, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Aesculap AG

Baxter Healthcare Corporation

Information provided by:

Rigshospitalet, Denmark

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 Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention
Official Title:	Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Frequency of chronic pain [ Time Frame: 6 months postoperatively ]

Secondary Outcome Measures:

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


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

Publications:

Aasvang E, Kehlet H. Surgical management of chronic pain after inguinal hernia repair. Br J Surg. 2005 Jul;92(7):795-801. Review.


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 Submitted:	March 28, 2008
First Posted:	April 1, 2008
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

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