Persistent Pain After Laparoscopic Inguinal Hernia Repair

This study has been completed.
Sponsor:
Collaborator:
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
  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 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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Gitte Linderoth, M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01085110     History of Changes
Other Study ID Numbers: H-2-2009-126-A
Study First Received: March 10, 2010
Last Updated: May 29, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by 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
Hernia, Inguinal
Neuralgia
Pain, Postoperative
Pathological Conditions, Anatomical
Hernia, Abdominal
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014