Persistent Pain After Laparoscopic Inguinal Hernia Repair

This study has been completed.

Sponsor:

Collaborator:

IMI Europain (Innovative Medicines Initiative)

Information provided by (Responsible Party):

Gitte Linderoth, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT01085110

First received: March 10, 2010

Last updated: May 29, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 10, 2010

Last Updated Date

May 29, 2012

Start Date ^ICMJE

January 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01085110 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Persistent Pain After Laparoscopic Inguinal Hernia Repair

Official Title ^ICMJE

Neurophysiological Characterization of Persistent Pain After Laparoscopic Inguinal Hernia Repair

Brief Summary

Describe and characterizes laparoscopic postherniotomy patients with persistent moderate/severe pain affecting every day activities - including detailed quantitative sensory assessment

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with persistent pain after laparoscpic inguinal hernia repair

Condition ^ICMJE

Pain, Postoperative
Neuropathic Pain
Postherniotomy Pain

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Persistent Pain patients

Patients with persistent postherniotomy pain after laparoscopic operation and pain related impaired daily function

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male patients > 18 yrs
No sign of hernia recurrence
Chronic groin pain lasting more than 3 months
Moderate/severe pain related impairment of everyday activities

Exclusion Criteria:

Other causes of persistent pain in groin region (hip, other surgical procedures)
Drug or alcohol abuse
Conflicting neurological disorders

Gender

Male

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01085110

Other Study ID Numbers ^ICMJE

H-2-2009-126-A

Has Data Monitoring Committee

Responsible Party

Gitte Linderoth, Rigshospitalet, Denmark

Study Sponsor ^ICMJE

Rigshospitalet, Denmark

Collaborators ^ICMJE

IMI Europain (Innovative Medicines Initiative)

Investigators ^ICMJE

Principal Investigator:	Gitte Linderoth, MD	Section of Surgical Pathophysiology, Rigshospitalet
Study Director:	Henrik Kehlet, MD, Proff	Section of Surgical Pathophysiology, Rigshospitalet

Information Provided By

Rigshospitalet, Denmark

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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