Postoperative Pain and Recurrences After Totally Extraperitoneal Endoscopic (TEP) vs. Lichtenstein Hernioplasty in Female Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post Operative Pain
- Sponsor
- Kuopio University Hospital
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Chronic pain
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •primary inguinal hernia in females
Exclusion Criteria
- •emergency operation
- •recurrent hernia
- •groin pain without hernia
- •frail and sick patient ASA ≥ 4
Outcomes
Primary Outcomes
Chronic pain
Time Frame: from 1 week to one year
Postoperative inguinal pain (vas scores 0-10) after 1 week, 4 weeks and one year of surgery
Secondary Outcomes
- Sick leave(0-30 days)
- Recurrence(5 years)
- Treatment costs(0-30 days)
- Complications(1 month)