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The aim of this study is to evaluate the outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who are planning multiport laparoscopic surgery for resection of kidney.
Study design:
This is a prospective, randomized, single center trial. This clinical trial was approved by the Institutional Review Boards.
Study process:
All patients gave informed written consent after being informed of the details of the study. Subjects were randomized into either the experimental group (specimen removal through posterior vagina fornix incision) or control groups (specimen removal through extended abdominal incision). All participants underwent demographic and history taking, laboratory tests, a gynecologic examination to determine whether specimen removal through vagina is possible.
To evaluate cosmesis, patient satisfaction and quality of life VAS (Visual Analogue Scale), SF-12 (Short Form-12) health survey, BIQ (Body Image Questionnaire) and POSAS (the Patient and Observer Scar Assessment Scale) will be sent to the patients 6 months after the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transabdominal specimen extraction | Active Comparator | The outcomes of transabdominal specimen extraction in a classic way in patients who underwent multiport laparoscopic surgery for resection of kidney |
|
| Transvaginal natural orifice specimen extraction (NOSE) | Experimental | The outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who underwent multiport laparoscopic surgery for resection of kidney |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvaginal natural orifice specimen extraction (NOSE) | Procedure | Under general anesthesia, patients who are planned to perform multiport laparoscopic surgery for resection of solid organs including kidney or bladder will undergo Transvaginal NOSE |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) | Cosmetic outcomes of scar assessed by Patient and Observer Scar Assessment Scale (POSAS) 1 week and 8 weeks after surgery. The POSAS is the international validated scar assessment questionnaire that measures quality of the scar from the perspective of both patient and observer. observer scar assessment scale (OSAS): good (1) - bad (10) - vascularization/ pigmentation/ thickness/ relief/ pliability patient scar assessment scale (PSAS): No (1) - Yes (10)
| post-op 1 week |
| Patient and Observer Scar Assessment Scale (POSAS) | Cosmetic outcomes of scar assessed by Patient and Observer Scar Assessment Scale (POSAS) 1 week and 8 weeks after surgery. The POSAS is the international validated scar assessment questionnaire that measures quality of the scar from the perspective of both patient and observer. observer scar assessment scale (OSAS): good (1) - bad (10) - vascularization/ pigmentation/ thickness/ relief/ pliability patient scar assessment scale (PSAS): No (1) - Yes (10)
| post-op 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal wound assessment | assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain | post-op 1 week |
| Vaginal wound assessment | assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2021 | Nov 21, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
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Transvaginal specimen extraction vs Transabdominal specimen extraction
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| Transabdominal specimen extraction | Procedure | Under general anesthesia, patients who are planned to perform multiport laparoscopic surgery for resection of solid organs including kidney or bladder will undergo transabdominal specimen extraction with incision elongation |
|
| post-op 8 weeks |
| Post-op pain assessment | Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10) | post-op 2hrs |
| Post-op pain assessment | Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10) | post-op 6hrs |
| Post-op pain assessment | Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10) | post-op 24hrs |
| Post-op pain assessment | Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10) | post-op 48hrs |
| Female Sexual Function Index (FSFI) questionnaire | Assessment Domain: Desire/ Arousal/ Lubrication/ Orgasm/ Satisfaction/ Pain Full scale score range: min 2.0 - max 36 | post-op 5 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |