Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hernia, Inguinal
- Sponsor
- Jacob Rosenberg
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- Proportion of patients with substantial pain related impairment of function
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Jacob Rosenberg
Professor
Herlev Hospital
Eligibility Criteria
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
- •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 \<
Outcomes
Primary Outcomes
Proportion of patients with substantial pain related impairment of function
Time Frame: 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
Time Frame: 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
Time Frame: 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.