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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult (>18 years)
- Male
- Primary unilateral groin hernia
- Ability to use pain scales
Exclusion Criteria:
- Neurological disease
- Diabetes with late stage complications

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