Onstep Versus Lichtenstein, the Onli Trial.
This study is currently recruiting participants.
Verified March 2013 by Herlev Hospital
Sponsor:
Jacob Rosenberg
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01753219
First received: December 17, 2012
Last updated: March 27, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hernia, Inguinal Chronic Pain |
Procedure: Onstep Procedure: Lichtenstein |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Herlev Hospital:
Primary Outcome Measures:
- Proportion of patients with chronic pain that impairs daily 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.
Secondary Outcome Measures:
- Proportion of patients with pain related impairment of sexual function [ Time Frame: 6 month ] [ Designated as safety issue: No ]At 6 month follow up participants will be asked to fill out a questionnaire assessing pain related impairment of sexual function.
- Early postoperative pain [ Time Frame: 10 days ] [ Designated as safety issue: No ]During the first ten days patient level of pain will be assessed daily with the use of Visual Analog Scale.
- Proportion of patients with pain that impairs daily function [ Time Frame: 12 month ] [ Designated as safety issue: No ]Participants will be asked to fill out questionnaires regarding chronic pain at the 12 month follow up.
| Estimated Enrollment: | 282 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Onstep
Participants in this group will have a inguinal hernia repair ad modum Onstep.
|
Procedure: Onstep |
|
Active Comparator: Lichtenstein
Participants in this group will receive a inguinal hernia repair ad modum Lichtenstein.
|
Procedure: Lichtenstein |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753219
Contacts
| Contact: Kristoffer Andresen | + 45 25 46 84 24 | kristofferandresen@gmail.com |
| Contact: Jakob Burcharth | +45 26 23 73 23 | jakobburcharth@gmail.com |
Locations
| Denmark | |
| Herlev Hospital | Recruiting |
| Herlev, Capital Region, Denmark, 2200 | |
| Contact: Kristoffer Andresen +45 25 46 84 24 kristofferandresen@gmail.com | |
| Contact: Jakob Burcharth + 45 26 27 62 26 jakobburcharth@gmail.com | |
| Hospitalsenheden Horsens | Recruiting |
| Horsens, Region Midt, Denmark, 8700 | |
| Contact: Maj-Britt Errebo, MD +4578426339 Maj.Britt.Errebo@aarhus.rm.dk | |
| Sub-Investigator: Maj-Britt Errebo, MD | |
Sponsors and Collaborators
Jacob Rosenberg
Investigators
| Study Chair: | Jacob Rosenberg, Professor | University of Copenhagen, Herlev Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jacob Rosenberg, Professor, Herlev Hospital |
| ClinicalTrials.gov Identifier: | NCT01753219 History of Changes |
| Other Study ID Numbers: | Onli |
| Study First Received: | December 17, 2012 |
| Last Updated: | March 27, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: Danish Health and Medicines Authority Denmark: Ethics Committee Denmark: National Board of Health Denmark: The Ministry of the Interior and Health Denmark: The Regional Committee on Biomedical Research Ethics |
Additional relevant MeSH terms:
|
Hernia Hernia, Inguinal Pathological Conditions, Anatomical Hernia, Abdominal |
ClinicalTrials.gov processed this record on June 17, 2013