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| Name | Class |
|---|---|
| Muğla Sıtkı Koçman University | OTHER |
| Bahçeşehir University | OTHER |
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Although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.
A randomized prospective study was conducted. Four groups of patients were constituted: (1) TEP with mesh fixation (2) TEP without fixation, (3) TAPP with mesh fixation, (4) TAPP without fixation. 120 patients were randomized to each group. The principal outcomes assessed were postoperative chronic groin pain assessed by visual analogue pain scale (VAS), hernia recurrence, other morbidity rates and hospital costs. Patients were reviewed in outpatient unit at 1 week and at 1, 6, 12 and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEP without fixation | Experimental | Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair without mesh fixation |
|
| TEP with fixation | Active Comparator | Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair |
|
| TAPP without fixation | Experimental | Standard transabdominal preperitoneal (TAPP) hernia repair without mesh fixation |
|
| TAPP with fixation | Active Comparator | Standard transabdominal preperitoneal (TAPP) hernia repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEP without fixation | Procedure | Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS) | neuralgia, inguinal | preoperative and postoperative 2nd year |
| Change from preoperative pain levels at 1 year assessed by the VAS | neuralgia, inguinal | preoperative and postoperative 1st year |
| Change from preoperative pain levels at 6 months assessed by the VAS | neuralgia, inguinal | preoperative and postoperative 6th month |
| Change from preoperative pain levels at 3 months assessed by the VAS | neuralgia, inguinal | preoperative and postoperative 3th month |
| Change from preoperative pain levels at 1 month assessed by the VAS | neuralgia, inguinal | preoperative and postoperative 1 month |
| Change from preoperative pain levels at 1 week assessed by the VAS | neuralgia, inguinal | preoperative and postoperative 1th week |
| Measure | Description | Time Frame |
|---|---|---|
| Total hospital costs | consisted all costs of hospital stays and outpatient treatments | up to 24 months |
| conversion rate | conversion to open surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Kaplan, M.D. | Bahçeşehir Üniversitesi Tıp Fakültesi | Principal Investigator |
| Onder Ozcan, M.D. | Mugla University, School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Park Gaziantep Hospital | Gaziantep | 27090 | Turkey (Türkiye) |
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| TEP with fixation | Procedure | Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair |
|
|
| TAPP without fixation | Procedure | Standard transabdominal preperitoneal (TAPP) inguinal hernia repair without mesh fixation |
|
|
| TAPP with fixation | Procedure | Standard transabdominal preperitoneal (TAPP) inguinal hernia repair |
|
|
| through the first day |
| recurrence rate | clinical and radiological diagnosed | up to 24 months |
| rate of minor and major complications | it was assessed as; no complication, minor complications, major complications and complications needed reoperation | 2 year |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D006550 | Hernia, Femoral |
| D012008 | Recurrence |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C072829 | tetraethylpyrazine |
| C034807 | tetra-4-amidinophenoxypropane |
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