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Selective Neurectomy and Mesh Removal for Chronic Postherniotomy Pain

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ClinicalTrials.gov Identifier: NCT00627289
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease
Pain

Study Design

Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Selective Neurectomy and Mesh Removal on Chronic Postherniotomy Pain
Study Start Date : February 2008
Primary Completion Date : December 2008
Study Completion Date : December 2008
Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. changes in AAS scores before and six months after operation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. changes in sensory function assessed by quantitative sensory testing [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00627289


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Ambulatory Surgical Clinic, Hørsholm Hospital
Hørsholm, Denmark, 2980
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:
Responsible Party: Eske Kvanner Aasvang, M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00627289     History of Changes
Other Study ID Numbers: (KF) 11 320499.
First Posted: March 3, 2008    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: October 2012

Keywords provided by Eske Kvanner Aasvang, Rigshospitalet, Denmark:
Chronic pain
groin hernia
neuropathic pain
chronic postoperative pain
Postherniotomy pain
Neuroplastic changes