Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Open hernioplasty, TEP hernioplasty.
- Who it may be relevant to
- Registry conditions: Post Operative Pain. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Postoperative Pain and Recurrences After Totally Extraperitoneal Endoscopic (TEP) vs. Lichtenstein Hernioplasty in Female Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
Overview
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
- Procedure Open hernioplasty
Inguinal hernia is operated using open surgery - Procedure TEP hernioplasty
Inguinal hernia is operated using laparoendoscopic technique
Primary outcome measures
- Chronic pain [Time frame: from 1 week to one year]
Secondary outcome measures (4)
- Complications [Time frame: 1 month]
- Recurrence [Time frame: 5 years]
- Sick leave [Time frame: 0-30 days]
- Treatment costs [Time frame: 0-30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- Mikkeli Central Hospital — Mikkeli
Identifiers
NCT: NCT05863624 · KUH5200667