Selective Neurectomy and Mesh Removal for Chronic Postherniotomy Pain

NCT00627289 | Completed

• 1 other identifier: (KF) 11 320499.
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 2

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

Conditions

Pain

Keywords

Chronic pain; groin hernia; neuropathic pain; chronic postoperative pain; Postherniotomy pain; Neuroplastic changes

Outcome Measures

Primary Outcomes (1)

• changes in AAS scores before and six months after operation

  6 months

Secondary Outcomes (1)

• changes in sensory function assessed by quantitative sensory testing

  6 months

Study Arms (1)

1

patients with chronic postherniotomy pain (\>1 year), affecting everyday activities severely

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• All that contradicts the above

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Ambulatory Surgical Clinic, Hørsholm Hospital

Hørsholm, 2980, Denmark

Location

Related Publications (1)

• Aasvang E, Kehlet H. Surgical management of chronic pain after inguinal hernia repair. Br J Surg. 2005 Jul;92(7):795-801. doi: 10.1002/bjs.5103.

  PMID: 15962258 BACKGROUND

MeSH Terms

Conditions

Pain; Chronic Pain; Hernia, Inguinal; Neuralgia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes

Study Officials

• Eske K Aasvang, M.D.

  Rigshospitalet, Copenhagen University, Denmark

  STUDY DIRECTOR

• Henrik Kehlet, M.D., Ph. D.

  Rigshospitalet, Copenhagen University, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: March 3, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 7, 2014

Record last verified: 2012-10

Locations

DK (2)