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Recent reports have suggested that transvaginal NOTES nephrectomy is feasible, yet comparative studies are lacking. The aim of this study was to compare the surgical outcomes of transvaginal NOTES nephrectomy to conventional laparoscopic nephrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transvaginal NOTES nephrectomy | Experimental | A 5- and 10-mm trocar were placed at the right and left medial margin of umbilicus. A lengthened 10-mm trocar was placed through the vagina into the abdominal cavity |
|
| conventional laparoscopic nephrectomy | Active Comparator | One 10-mm trocar was inserted at the midclavicular line 2 cm below the umbilicus, another 10-mm periumbilical trocar was placed for the camera, and a 5- or 10-mm trocar was placed 3 cm below the costal margin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transvaginal NOTES nephrectomy | Procedure | A 5- and 10-mm trocar were placed at the right and left medial margin of umbilicus. A lengthened 10-mm trocar was placed through the vagina into the abdominal cavity |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of pain in motion (Pain Scores on the Visual Analog Scale (0-10) | Pain Scores on the Visual Analog Scale (0-10) | at postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic assessment (Patient Scar Assessment Questionnaire) | The cosmetic result was assessed using a Patient Scar Assessment Questionnaire and Scoring System (PSAQ) | > 3 months after surgery |
| Sexual function (Female Sexual Function Index) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofeng Zou, MD | Contact | +86-797-8269588 | gyfyurology@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Gannan Medical University | Recruiting | Ganzhou | Jiangxi | 341000 | China |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| conventional laparoscopic nephrectomy | Procedure | One 10-mm trocar was inserted at the midclavicular line 2 cm below the umbilicus, another 10-mm periumbilical trocar was placed for the camera, and a 5- or 10-mm trocar was placed 3 cm below the costal margin |
|
Sexual function was evaluated according to the Female Sexual Function Index
| Preoperatively, and 4, 8 and 12 months postoperatively |
| Intraoperative complications (e.g. bleeding, organ-injury) | e.g. bleeding, organ-injury | Evaluated at the operation day |
| Duration of the operation | in minutes | at the operation day |
| Quality of life (SF-36) | measured with the | on postoperative month 1 |
| Postoperative complication (classified using the Clavien-Dindo system) | Early (≤ 1 month) and late (> 1 month) complications were classified using the Clavien-Dindo system | early (≤ 1 month), or late (>1 month) |
| D052801 | Male Urogenital Diseases |