Trial record 2 of 64 for:    Open Studies | "Hernia, Inguinal"

Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach (ONLAP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01960777
First received: October 9, 2013
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

The objective of this study is to evaluate chronic pain after inguinal hernia repair involving mesh placement with the Onstep-technique compared to mesh placement using a laparoscopic approach. The study hypothesis is that an even or smaller proportions of patients operated the Onstep technique will have chronic pain that impairs daily function.


Condition Intervention
Hernia, Inguinal
Chronic Pain
Procedure: Onstep
Procedure: Laparoscopic repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Proportion of patients with substantial pain related impairment of function [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    At the 6 month follow up, all participants will be asked to fill out questionnaires regarding pain. Questionnaire used will assess degree of pain and degree of impairment on daily function.

  • Early postoperative pain [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Early postoperative pain, measured on postoperative day 1, 2, 3 and 10 on the VAS for pain and compared between groups.

  • Pain related impairment of function at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    At the 12 months follow up, all participants will be asked to fill out questionnaires regarding pain. Questionnaire used will assess degree of pain and degree of impairment on daily function.


Estimated Enrollment: 188
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Onstep
Participants in this group will have an inguinal hernia repair ad modum Onstep.
Procedure: Onstep
Active Comparator: Laparoscopic repair
Participants in this group will receive an inguinal hernia repair by use of a laparoscopic approach.
Procedure: Laparoscopic repair

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnose of a primary groin hernia that requires surgical intervention.
  • Eligible for procedure performed under general anesthesia.
  • Eligible for both laparoscopic and Onstep procedure.

Exclusion Criteria:

  • Not able to understand Danish/Swedish, written and spoken.
  • Emergency procedures.
  • Previous inguinal hernia on ipsilateral side.
  • ASA score more than 3.
  • Irreducible inguinoscrotal hernia.
  • Local or systemic infection.
  • Contralateral hernia being operated at the same time or planned operated during follow-up.
  • Other abdominal hernias being operated at the same time or planned operated during follow-up.
  • Previous surgery that has impaired the sensation in the groin area.
  • BMI > 40 or < 20.
  • Daily intake of alcohol >5 units, 1 unit = 12g pure alcohol.
  • Known disease which impairs central or peripheral nerve function.
  • Concurrent malignant disease.
  • Impairment of cognitive function (e.g. dementia).
  • Chronic pain that requires medication.
  • Mental disorder that requires medication.
  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: NCT01960777

Contacts
Contact: Kristoffer Andresen +4525468424 kristoffer.andresen.01@regionh.dk

Locations
Denmark
Department of Surgery, Herlev Hospital Not yet recruiting
Herlev, Denmark
Sponsors and Collaborators
Jacob Rosenberg
Investigators
Study Chair: Jacob Rosenberg, Professor University of Copenhagen, Herlev Hospital
  More Information

No publications provided

Responsible Party: Jacob Rosenberg, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01960777     History of Changes
Other Study ID Numbers: ONLAP
Study First Received: October 9, 2013
Last Updated: October 10, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Health and Medicines Authority
Denmark: Ethics Committee
Denmark: National Board of Health
Denmark: The Ministry of the Interior and Health
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Herlev Hospital:
Hernia, Inguinal
Laparoscopy
Onstep

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Chronic Pain
Pathological Conditions, Anatomical
Hernia, Abdominal
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014