NCT01753219

Brief Summary

The objective of this study is to evaluate chronic pain and sexual dysfunction after inguinal hernia repair involving mesh fixation with sutures (Lichtenstein) compared with no mesh fixation (Onstep). The study hypothesis is that a smaller proportions of patients operated without mesh fixation (Onstep) 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
290

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

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

December 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

1.5 years

First QC Date

December 17, 2012

Last Update Submit

August 17, 2015

Conditions

Hernia, InguinalChronic Pain

Outcome Measures

Primary Outcomes (4)

  • Proportion of patients with chronic pain that impairs daily 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

  • Proportion of patients with pain related impairment of sexual function

    At 6 and 12 month followup participants will be asked to fill out a questionnaire assessing pain related impairment of sexual function.

    6 month + 12 month

  • Proportion of patients with pain that impairs daily function

    At the 12 month follow up, all pariticipants will be asked to fill out qestionnares regarding pain. Questionnaire used will assess degree of pain and degree of impairment of daily function.

    12 month

  • Early postoperative pain

    During the first 10 days, level of pain will be assessed using a Visual Analog Scale.

    10 days

Other Outcomes (5)

  • 30 day complications

    30 days

  • Cut to suture time

    Peroperative

  • Lenght of hospital stay

    Days

  • +2 more other outcomes

Study Arms (2)

Onstep

EXPERIMENTAL

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

Procedure: Onstep

Lichtenstein

ACTIVE COMPARATOR

Participants in this group will receive a inguinal hernia repair ad modum Lichtenstein.

Procedure: Lichtenstein

Interventions

OnstepPROCEDURE
Onstep
LichtensteinPROCEDURE
Lichtenstein

Eligibility Criteria

Age18 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

You may not qualify if:

  • Not able to understand Danish, written and spoken.
  • Emergency procedures
  • Previous inguinal hernia on ipsilateral side.
  • ASA score more than 3.
  • Incarcerated or irreducible hernia.
  • Local (site of surgery) 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 that impairs central or peripheral nerve function.
  • Concurrent malignant disease.
  • Impairment of cognitive function (e.g. dementia).
  • Chronic pain that requires daily medication.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Herlev Hospital

Herlev, Capital Region, 2200, Denmark

Location

Hospitalsenheden Horsens

Horsens, Region Midt, 8700, Denmark

Location

Hobro Sygehus

Hobro, 9500, Denmark

Location

Kolding Sygehus

Kolding, 6000, Denmark

Location

Related Publications (4)

  • Andresen K, Burcharth J, Rosenberg J. Lichtenstein versus Onstep for inguinal hernia repair: protocol for a double-blinded randomised trial. Dan Med J. 2013 Nov;60(11):A4729.

    PMID: 24192245BACKGROUND

  • Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D, Sorensen FS, Bjerg J, Rosenberg J. Sexual dysfunction after inguinal hernia repair with the Onstep versus Lichtenstein technique: A randomized clinical trial. Surgery. 2017 Jun;161(6):1690-1695. doi: 10.1016/j.surg.2016.12.030. Epub 2017 Mar 2.

    PMID: 28262253DERIVED

  • Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D, Sorensen FS, Bjerg J, Rosenberg J. Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial. Langenbecks Arch Surg. 2017 Mar;402(2):213-218. doi: 10.1007/s00423-016-1532-y. Epub 2016 Nov 11.

    PMID: 27837273DERIVED

  • Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D, Sorensen FS, Bjerg J, Rosenberg J. Short-term outcome after Onstep versus Lichtenstein technique for inguinal hernia repair: results from a randomized clinical trial. Hernia. 2015 Dec;19(6):871-7. doi: 10.1007/s10029-015-1428-8. Epub 2015 Oct 7.

    PMID: 26445862DERIVED

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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 20, 2012

Study Start

March 1, 2013

Primary Completion

September 1, 2014

Study Completion

August 1, 2015

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

DK(4)