Hernia, Inguinal, Chronic Pain
Conditions
Keywords
Hernia, Inguinal, Laparoscopy, Onstep
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.
Interventions
PROCEDUREOnstep
PROCEDURELaparoscopic repair
Sponsors
Jacob Rosenberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Mental disorder that requires medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with substantial pain related impairment of 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. |
| Early postoperative pain | 10 days | Early postoperative pain, measured on postoperative day 1, 2, 3 and 10 on the VAS for pain and compared between groups. |
| Pain related impairment of function at 12 months | 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. |
Countries
Denmark
Outcome results
None listed