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 Intervention Model: Parallel Assignment Masking: 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


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

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:

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
Study First Received:	March 28, 2008
Last Updated:	January 20, 2009

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 June 22, 2017

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