Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Lichtenstein hernioplasty Lichtenstein hernia repair |
Procedure: Lichtenstein hernioplasty vs TEP hernioplasty
surgical procedures in inguinal hernia
Other Names:
|
Active Comparator: TEP hernioplasty totally endoscopic hernia repair (TEP) |
Procedure: Lichtenstein hernioplasty vs TEP hernioplasty
surgical procedures in inguinal hernia
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Complications [1 month]
Postoperative complications of surgery (wound infection, hemorrhage)
- Recurrence [5 years]
Hernia recurrences after 5 years
- Sick leave [0-30 days]
how many days the patient is not working after surgery
- Treatment costs [0-30 days]
how much in euros the surgical treatment will cost
Eligibility Criteria
Criteria
Inclusion Criteria:
- primary inguinal hernia in females
Exclusion Criteria:
-
emergency operation
-
recurrent hernia
-
groin pain without hernia
-
frail and sick patient ASA ≥ 4
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mikkeli Central Hospital | Mikkeli | Finland | 50100 |
Sponsors and Collaborators
- Kuopio University Hospital
- Helsinki University Central Hospital
- Päijänne Tavastia Central Hospital
- North Karelia Central Hospital
- Jyväskylä Central Hospital
- Mikkeli Central Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KUH5200667