Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

Not Applicable

Not yet recruiting

• Conditions: Post Operative Pain
• Interventions: Procedure: Open hernioplasty; Procedure: TEP hernioplasty

• Registration Number: NCT05863624
• Lead Sponsor: Kuopio University Hospital

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.

Study Timeline

• Study First Submitted: 2023-04-17
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-18
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Study Start: 2024-09-01
• Primary Completion: 2024-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 170

Inclusion Criteria

• primary inguinal hernia in females

Exclusion Criteria

• emergency operation
• recurrent hernia
• groin pain without hernia
• frail and sick patient ASA ≥ 4

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open hernioplasty	Open hernioplasty	Open Lichtenstein hernia repair
TEP hernioplasty	TEP hernioplasty	totally endoscopic hernia repair (TEP)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Sick leave	0-30 days	how many days the patient is not working after surgery
Recurrence	5 years	Hernia recurrences after 5 years
Treatment costs	0-30 days	how much in euros the surgical treatment will cost
Complications	1 month	Postoperative complications of surgery (wound infection, hemorrhage)

Trial Locations

Locations (1)

Mikkeli Central Hospital; 🇫🇮 Mikkeli, Finland