Clinical trial NCT01753219: Onstep Versus Lichtenstein, the Onli Trial.
Official title: Effect of Suture for Mesh Fixation on Pain and Other Complications in Patients Undergoing Inguinal Hernia Repair: a Double-blind, Randomized Study Comparing the Lichtenstein With the Onstep Technique - the ONLI Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Chronic Pain
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 290
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnose of a primary groin hernia that requires surgical intervention.
* Eligible for procedure performed under general anesthesia

Exclusion Criteria:

* 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.
* Mental disorder that requires medication.

Primary outcomes:
measure: Proportion of patients with chronic pain that impairs daily function
timeFrame: 6 month
measure: Proportion of patients with pain related impairment of sexual function
timeFrame: 6 month + 12 month
measure: Proportion of patients with pain that impairs daily function
timeFrame: 12 month
measure: Early postoperative pain
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
measure: 30 day complications
timeFrame: 30 days
measure: Cut to suture time
timeFrame: Peroperative
measure: Lenght of hospital stay
timeFrame: Days
measure: Time to return to normal daily activities
timeFrame: Days or weeks
measure: Patients comfort
timeFrame: 6 and 12 month
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Capital Region
city: Horsens
country: Denmark
facility: Hospitalsenheden Horsens
state: Region Midt
city: Hobro
country: Denmark
facility: Hobro Sygehus
city: Kolding
country: Denmark
facility: Kolding Sygehus
Study officials:
affiliation: University of Copenhagen, Herlev Hospital
name: Jacob Rosenberg, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.