Onstep Versus Lichtenstein, the Onli Trial.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with chronic pain that impairs daily function [6 month]
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.
- Proportion of patients with pain related impairment of sexual function [6 month + 12 month]
At 6 and 12 month followup participants will be asked to fill out a questionnaire assessing pain related impairment of sexual function.
- Proportion of patients with pain that impairs daily function [12 month]
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.
- Early postoperative pain [10 days]
During the first 10 days, level of pain will be assessed using a Visual Analog Scale.
Other Outcome Measures
- 30 day complications [30 days]
Complications, occuring within the first 30 postoperative days will be recorded by telephone interview on day 30.
- Cut to suture time [Peroperative]
The cut to suture time will be recorded by the staff in the operating room.
- Lenght of hospital stay [Days]
- Time to return to normal daily activities [Days or weeks]
- Patients comfort [6 and 12 month]
Patients comfort with the operated hernia be assessed using questionnaires.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinical diagnose of a primary groin hernia that requires surgical intervention.
-
Eligible for procedure performed under general anesthesia
Exclusion Criteria:
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Not able to understand Danish, written and spoken.
-
Emergency procedures
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Previous inguinal hernia on ipsilateral side.
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ASA score more than 3.
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Incarcerated or irreducible hernia.
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Local (site of surgery) or systemic infection.
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Contralateral hernia being operated at the same time or planned operated during follow-up.
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Other abdominal hernias being operated at the same time or planned operated during follow-up.
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Previous surgery that has impaired the sensation in the groin area.
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BMI > 40 or < 20.
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Daily intake of alcohol >5 units, 1 unit = 12g pure alcohol.
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Known disease that impairs central or peripheral nerve function.
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Concurrent malignant disease.
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Impairment of cognitive function (e.g. dementia).
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Chronic pain that requires daily medication.
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Mental disorder that requires medication.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herlev Hospital | Herlev | Capital Region | Denmark | 2200 |
| 2 | Hospitalsenheden Horsens | Horsens | Region Midt | Denmark | 8700 |
| 3 | Hobro Sygehus | Hobro | Denmark | 9500 | |
| 4 | Kolding Sygehus | Kolding | Denmark | 6000 |
Sponsors and Collaborators
- Jacob Rosenberg
Investigators
- Study Chair: Jacob Rosenberg, Professor, University of Copenhagen, Herlev Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Onli