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Persistent Pain After Laparoscopic Inguinal Hernia Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085110
First Posted: March 11, 2010
Last Update Posted: May 30, 2012
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.
Collaborator:
Innovative Medicines Initiative
Information provided by (Responsible Party):
Gitte Linderoth, Rigshospitalet, Denmark
  Purpose
Describe and characterizes laparoscopic postherniotomy patients with persistent moderate/severe pain affecting every day activities - including detailed quantitative sensory assessment

Condition
Pain, Postoperative Neuropathic Pain Postherniotomy Pain

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Neurophysiological Characterization of Persistent Pain After Laparoscopic Inguinal Hernia Repair

Resource links provided by NLM:


Further study details as provided by Gitte Linderoth, Rigshospitalet, Denmark:

Enrollment: 11
Study Start Date: January 2010
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Persistent Pain patients
Patients with persistent postherniotomy pain after laparoscopic operation and pain related impaired daily function

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with persistent pain after laparoscpic inguinal hernia repair
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085110


Locations
Denmark
Section of Surgical Pathophysiology, Rigshospitalet, Copenhagen University
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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
  More Information

Responsible Party: Gitte Linderoth, M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01085110     History of Changes
Other Study ID Numbers: H-2-2009-126-A
First Submitted: March 10, 2010
First Posted: March 11, 2010
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by Gitte Linderoth, Rigshospitalet, Denmark:
Groin hernia
Chronic pain
QST
Quantitative sensory testing
Persistent postoperative pain
Laparoscopic inguinal herniotomy
Postherniotomy Pain after laparoscopic inguinal herniotomy
laparoscopic inguinal hernia repair

Additional relevant MeSH terms:
Hernia
Neuralgia
Hernia, Inguinal
Pain, Postoperative
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Hernia, Abdominal
Postoperative Complications
Pathologic Processes