NCT05863624

Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

Postoperative Pain and Recurrences After Totally Extraperitoneal Endoscopic (TEP) vs. Lichtenstein Hernioplasty in Female Inguinal Hernia Repair: a Prospective Randomized Multi-center Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Kuopio University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
PROCEDURE	Open hernioplasty	Inguinal hernia is operated using open surgery
PROCEDURE	TEP hernioplasty	Inguinal hernia is operated using laparoendoscopic technique

Timeline

• Start date: 2024-09-01
• Primary completion: 2024-12-31
• Completion: 2029-12-31
• First posted: 2023-05-18
• Last updated: 2024-03-06

Locations

1 site across 1 country: Finland