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Persistent Pain After Laparoscopic Inguinal Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01085110
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : May 30, 2012
Sponsor:
Collaborator:
Innovative Medicines Initiative
Information provided by (Responsible Party):
Gitte Linderoth, Rigshospitalet, Denmark

Tracking Information
First Submitted Date March 10, 2010
First Posted Date March 11, 2010
Last Update Posted Date May 30, 2012
Study Start Date January 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01085110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Persistent Pain After Laparoscopic Inguinal Hernia Repair
Official Title 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 Observational
Study Design 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
  • Pain, Postoperative
  • Neuropathic Pain
  • Postherniotomy Pain
Intervention Not Provided
Study Groups/Cohorts 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 Completed
Actual Enrollment
 (submitted: March¬†10,¬†2010)
11
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01085110
Other Study ID Numbers H-2-2009-126-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gitte Linderoth, Rigshospitalet, Denmark
Study Sponsor Rigshospitalet, Denmark
Collaborators Innovative Medicines Initiative
Investigators
Principal Investigator: Gitte Linderoth, MD Section of Surgical Pathophysiology, Rigshospitalet
Study Director: Henrik Kehlet, MD, Proff Section of Surgical Pathophysiology, Rigshospitalet
PRS Account Rigshospitalet, Denmark
Verification Date May 2012