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

Primary Purpose

Hernia, Inguinal, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Onstep
Laparoscopic repair
Sponsored by
Jacob Rosenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring Hernia, Inguinal, Laparoscopy, Onstep

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Surgery, Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Onstep

Laparoscopic repair

Arm Description

Participants in this group will have an inguinal hernia repair ad modum Onstep.

Participants in this group will receive an inguinal hernia repair by use of a laparoscopic approach.

Outcomes

Primary Outcome Measures

Proportion of patients with substantial pain related impairment of function
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
October 9, 2013
Last Updated
February 22, 2018
Sponsor
Jacob Rosenberg
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1. Study Identification

Unique Protocol Identification Number
NCT01960777
Brief Title
Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach
Acronym
ONLAP
Official Title
Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacob Rosenberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal, Chronic Pain
Keywords
Hernia, Inguinal, Laparoscopy, Onstep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Onstep
Arm Type
Experimental
Arm Description
Participants in this group will have an inguinal hernia repair ad modum Onstep.
Arm Title
Laparoscopic repair
Arm Type
Active Comparator
Arm Description
Participants in this group will receive an inguinal hernia repair by use of a laparoscopic approach.
Intervention Type
Procedure
Intervention Name(s)
Onstep
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic repair
Primary Outcome Measure Information:
Title
Proportion of patients with substantial pain related impairment of function
Description
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.
Time Frame
6 month
Title
Early postoperative pain
Description
Early postoperative pain, measured on postoperative day 1, 2, 3 and 10 on the VAS for pain and compared between groups.
Time Frame
10 days
Title
Pain related impairment of function at 12 months
Description
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.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Rosenberg, Professor
Organizational Affiliation
University of Copenhagen, Herlev Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Surgery, Herlev Hospital
City
Herlev
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26621399
Citation
Andresen K, Burcharth J, Rosenberg J. ONSTEP versus laparoscopy for inguinal hernia repair: protocol for a randomised clinical trial. Dan Med J. 2015 Dec;62(12):A5169.
Results Reference
derived

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

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