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NCT00627289 Clinical Trial

Selective Neurectomy and Mesh Removal for Chronic Postherniotomy Pain

Pain Clinical Trial

Official title:
The Effect of Selective Neurectomy and Mesh Removal on Chronic Postherniotomy Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00627289
Other study ID # (KF) 11 320499.
Secondary ID
Status Completed
Phase N/A
First received February 12, 2008
Last updated April 4, 2014
Start date February 2008
Est. completion date December 2008

Study information
Verified date October 2012
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen
Denmark Ambulatory Surgical Clinic, Hørsholm Hospital Hørsholm

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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

Outcome
Type Measure Description Time frame Safety issue
Primary changes in AAS scores before and six months after operation 6 months Yes
Secondary changes in sensory function assessed by quantitative sensory testing 6 months Yes
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