Selective Neurectomy and Mesh Removal for Chronic Postherniotomy Pain

NCT ID: NCT00627289

Last Updated: 2014-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eske Kvanner Aasvang

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eske K Aasvang, M.D.

Role: STUDY_DIRECTOR

Rigshospitalet, Copenhagen University, Denmark

Henrik Kehlet, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Copenhagen University, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rigshospitalet

Copenhagen, , Denmark

Site Status

Ambulatory Surgical Clinic, Hørsholm Hospital

Hørsholm, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15962258 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

(KF) 11 320499.

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Chronic Pain After Inguinal Hernia Repair
NCT00820131 COMPLETED PHASE4