Selective Neurectomy and Mesh Removal for Chronic Postherniotomy Pain

This study is currently recruiting participants.

Verified by Rigshospitalet, Denmark, August 2008

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00627289

Purpose

Chronic postherniotomy pain affects every day activities in 5-8% of patients. However, no established treatment for this pain syndrome exists and previous reports on the effect of surgical intervention suffer from methodological problems. The neurophysiological characteristics suggest that pain arises from deeper neuronal structures injured during surgery or by ongoing inflammation from the mesh. This study investigates the effect of removing inserted mesh and compressed nerves on pain related daily impairment of activities assessed by the validated AAS questionnaire before and 6 months after surgery

Condition
Pain

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	The Effect of Selective Neurectomy and Mesh Removal on Chronic Postherniotomy Pain

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

changes in AAS scores before and six months after operation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

changes in sensory function assessed by quantitative sensory testing [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	February 2008

Groups/Cohorts
1 patients with chronic postherniotomy pain (>1 year), affecting everyday activities severely

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with chronic pain occuring after groin hernia repair. Patients must experience moderate/severe pain related impairment of everyday activities. Patients have to be able to localize a maximum point of pain.

Criteria

Inclusion Criteria:

Adult ( more than 18 years old) patients with chronic pain after groin hernia surgery, and pain related impairment of everyday function. The pain should have occurred after previous open surgery.
The patient should be able to locate to a specific area with maximum pain. Patients should be able to understand and use pain scales, and the AAS-scale.

Exclusion Criteria:

All that contradicts the above

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627289

Contacts

Contact: Eske K Aasvang, M.D.	004526232076	eskeaasvang@yahoo.dk
Contact: Henrik Kehlet, M.D., Ph. D.	004535454074	henrik.kehlet@rh.regionh.dk

Locations

Denmark
Ambulatory Surgical Clinic, Hørsholm Hospital	Recruiting
Hørsholm, Denmark, 2980
Contact: Jørgen Malmstrøm, M.D. 004548292929
Rigshospitalet	Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Henrik Kehlet, M.D., Ph.D. 004535454074 henrik.kehlet@rh.regionh.dk

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Study Director:	Eske K Aasvang, M.D.	Rigshospitalet, Copenhagen University, Denmark
Principal Investigator:	Henrik Kehlet, M.D., Ph. D.	Rigshospitalet, Copenhagen University, Denmark

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:	Rigshospitalet ( Henrik Kehlet, Professor, Ph D, M.D. )
Study ID Numbers:	(KF) 11 320499.
Study First Received:	February 12, 2008
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00627289
Health Authority:	Denmark: Ethics Committee; Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:

Chronic pain
groin hernia
neuropathic pain

chronic postoperative pain
Postherniotomy pain
Neuroplastic changes

Study placed in the following topic categories:

Hernia
Pain
Pain, Postoperative

ClinicalTrials.gov processed this record on January 16, 2009