Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post Operative Pain

Intervention / Treatment
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* Procedure: Open hernioplasty
* Procedure: TEP hernioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary inguinal hernia in females Exclusion Criteria: emergency operation recurrent hernia groin pain without hernia frail and sick patient ASA ≥ 4

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized follow-up study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open hernioplasty<br>Open Lichtenstein hernia repair | Procedure: Open hernioplasty<br>* Inguinal hernia is operated using open surgery<br>* Other names: Open Lichtenstein hernia repair;|
| Active Comparator: TEP hernioplasty<br>totally endoscopic hernia repair (TEP) | Procedure: TEP hernioplasty<br>* Inguinal hernia is operated using laparoendoscopic technique<br>* Other names: totally endoscopic hernia repair (TEP);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain | Postoperative inguinal pain (vas scores 0-10) after 1 week, 4 weeks and one year of surgery | from 1 week to one year | 

Secondary Outcome Measures

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