NCT01960777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

3.3 years

First QC Date

October 9, 2013

Last Update Submit

February 22, 2018

Conditions

Hernia, InguinalChronic Pain

Keywords

Hernia, InguinalLaparoscopyOnstep

Outcome Measures

Primary Outcomes (3)

  • 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.

    6 month

  • Early postoperative pain

    Early postoperative pain, measured on postoperative day 1, 2, 3 and 10 on the VAS for pain and compared between groups.

    10 days

  • 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.

    12 months

Study Arms (2)

Onstep

EXPERIMENTAL

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

Procedure: Onstep

Laparoscopic repair

ACTIVE COMPARATOR

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

Procedure: Laparoscopic repair

Interventions

OnstepPROCEDURE
Onstep
Laparoscopic repairPROCEDURE
Laparoscopic repair

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Herlev Hospital

Herlev, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 26621399DERIVED

MeSH Terms

Conditions

Hernia, InguinalChronic Pain

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Jacob Rosenberg, Professor

    University of Copenhagen, Herlev Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 11, 2013

Study Start

March 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

DK(1)