Post Operative Pain
Conditions
Brief summary
This randomized study compares open inguinal hernia repair (Lichtenstein hernioplasty) to endoscopic repair (TEP) in terms of chronic pain and recurrences in one and five years after operation.
Detailed description
The best operative technique in female inguinal hernia is not known. Some register studies recommend always laparoscopic hernia repair in females, but there are no randomized studies to show that laparoscopic repair is better than open hernioplasty. Our study compares operative complications, chronic pain and recurrences in Lichtenstein operation to totally endoscopic hernia repair (TEP) in 170 female patients with primary inguinal hernia. The patients are operated in six Finnish hospitals, randomized into 85 Lichtenstein vs 85 TEP and followed 1 week, 4 weeks, 12 months and 5 years. Main end-point in postoperative pain after one year, sencondary endpoints are sick leave, return to normal physical activity, complications of treatment, re-operations, chronic pain and costs of treatment.
Interventions
PROCEDUREOpen hernioplasty
Inguinal hernia is operated using open surgery
PROCEDURETEP hernioplasty
Inguinal hernia is operated using laparoendoscopic technique
Sponsors
Helsinki University Central Hospital
Päijänne Tavastia Central Hospital
North Karelia Central Hospital
Jyväskylä Central Hospital
Mikkeli Central Hospital
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized follow-up study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* primary inguinal hernia in females
Exclusion criteria
* emergency operation * recurrent hernia * groin pain without hernia * frail and sick patient ASA ≥ 4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic pain | from 1 week to one year | Postoperative inguinal pain (vas scores 0-10) after 1 week, 4 weeks and one year of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 1 month | Postoperative complications of surgery (wound infection, hemorrhage) |
| Recurrence | 5 years | Hernia recurrences after 5 years |
| Sick leave | 0-30 days | how many days the patient is not working after surgery |
| Treatment costs | 0-30 days | how much in euros the surgical treatment will cost |
Countries
Finland
Contacts
Primary ContactHannu EK Paajanen, MD
Outcome results
None listed