Selective Neurectomy and Mesh Removal for Chronic Postherniotomy Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eske Kvanner Aasvang, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00627289
First received: February 12, 2008
Last updated: April 4, 2014
Last verified: October 2012
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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 ]

Enrollment: 21
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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
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: 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.
Study First Received: February 12, 2008
Last Updated: April 4, 2014
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

ClinicalTrials.gov processed this record on October 20, 2014