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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Herlev Hospital
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital Identifier:
First received: October 9, 2013
Last updated: February 22, 2016
Last verified: February 2016
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: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 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


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

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 identifier: NCT01960777

Contact: Kristoffer Andresen +4525468424

Department of Surgery, Herlev Hospital Recruiting
Herlev, Denmark
Contact: Kristoffer Andresen, MD    +4525468424   
Sponsors and Collaborators
Jacob Rosenberg
Study Chair: Jacob Rosenberg, Professor University of Copenhagen, Herlev Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jacob Rosenberg, Professor, Herlev Hospital Identifier: NCT01960777     History of Changes
Other Study ID Numbers: ONLAP 
Study First Received: October 9, 2013
Last Updated: February 22, 2016
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Health and Medicines Authority
Denmark: Ethics Committee
Denmark: National Board of Health
Denmark: Ministry of Health
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Herlev Hospital:
Hernia, Inguinal

Additional relevant MeSH terms:
Chronic Pain
Hernia, Inguinal
Hernia, Abdominal
Nervous System Diseases
Neurologic Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms processed this record on April 27, 2016