Selective Neurectomy and Mesh Removal for Chronic Postherniotomy Pain
This study is currently recruiting participants.
Verified October 2012 by Rigshospitalet, Denmark
Sponsor:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Eske Kvanner Aasvang, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00627289
First received: February 12, 2008
Last updated: October 3, 2012
Last verified: October 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 12, 2008 | ||||||||
| Last Updated Date | October 3, 2012 | ||||||||
| Start Date ICMJE | February 2008 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
changes in AAS scores before and six months after operation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00627289 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
changes in sensory function assessed by quantitative sensory testing [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Selective Neurectomy and Mesh Removal for Chronic Postherniotomy Pain | ||||||||
| Official Title ICMJE | The Effect of Selective Neurectomy and Mesh Removal on Chronic Postherniotomy Pain | ||||||||
| 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 |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
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| Condition ICMJE | Pain | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | 1
patients with chronic postherniotomy pain (>1 year), affecting everyday activities severely |
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| Publications * | Aasvang E, Kehlet H. Surgical management of chronic pain after inguinal hernia repair. Br J Surg. 2005 Jul;92(7):795-801. Review. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00627289 | ||||||||
| Other Study ID Numbers ICMJE | (KF) 11 320499. | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Eske Kvanner Aasvang, Rigshospitalet, Denmark | ||||||||
| Study Sponsor ICMJE | Rigshospitalet, Denmark | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Rigshospitalet, Denmark | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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