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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| Päijänne Tavastia Central Hospital | OTHER |
| North Karelia Central Hospital | OTHER |
| Jyväskylä Central Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open hernioplasty | Experimental | Open Lichtenstein hernia repair |
|
| TEP hernioplasty | Active Comparator | totally endoscopic hernia repair (TEP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open hernioplasty | Procedure | Inguinal hernia is operated using open surgery |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Postoperative complications of surgery (wound infection, hemorrhage) | 1 month |
| Recurrence | Hernia recurrences after 5 years |
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Inclusion Criteria:
Exclusion Criteria:
This study includes only females
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannu EK Paajanen, MD | Contact | 0405263101 | +358 | paajanen@surffi.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mikkeli Central Hospital | Mikkeli | 50100 | Finland |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| OTHER |
| Mikkeli Central Hospital | OTHER |
Randomized follow-up study
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| TEP hernioplasty | Procedure | Inguinal hernia is operated using laparoendoscopic technique |
|
|
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |