Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05135520
Status:
UNKNOWN
Last Update Posted:
2021-11-26
First Post:
2021-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}], 'ancestors': [{'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-20', 'size': 90605, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-11-21T05:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Transvaginal specimen extraction vs Transabdominal specimen extraction'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-11-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-22', 'studyFirstSubmitDate': '2021-11-04', 'studyFirstSubmitQcDate': '2021-11-22', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient and Observer Scar Assessment Scale (POSAS)', 'timeFrame': 'post-op 1 week', 'description': '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.\n\nobserver scar assessment scale (OSAS): good (1) - bad (10)\n\n\\- vascularization/ pigmentation/ thickness/ relief/ pliability\n\npatient scar assessment scale (PSAS): No (1) - Yes (10)\n\n* Is the scar painful?\n* Is the scar itching?\n* Is the scar color different from the color of your normal skin?\n* Is the stiffness of the scar different from the color of your normal skin?\n* Is the thickness of the scar different from the color of your normal skin?\n* Is the scar more irregular than your normal skin?'}, {'measure': 'Patient and Observer Scar Assessment Scale (POSAS)', 'timeFrame': 'post-op 8 weeks', 'description': '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.\n\nobserver scar assessment scale (OSAS): good (1) - bad (10)\n\n\\- vascularization/ pigmentation/ thickness/ relief/ pliability\n\npatient scar assessment scale (PSAS): No (1) - Yes (10)\n\n* Is the scar painful?\n* Is the scar itching?\n* Is the scar color different from the color of your normal skin?\n* Is the stiffness of the scar different from the color of your normal skin?\n* Is the thickness of the scar different from the color of your normal skin?\n* Is the scar more irregular than your normal skin?'}], 'secondaryOutcomes': [{'measure': 'Vaginal wound assessment', 'timeFrame': 'post-op 1 week', 'description': 'assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain'}, {'measure': 'Vaginal wound assessment', 'timeFrame': 'post-op 8 weeks', 'description': 'assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain'}, {'measure': 'Post-op pain assessment', 'timeFrame': 'post-op 2hrs', 'description': 'Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)'}, {'measure': 'Post-op pain assessment', 'timeFrame': 'post-op 6hrs', 'description': 'Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)'}, {'measure': 'Post-op pain assessment', 'timeFrame': 'post-op 24hrs', 'description': 'Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)'}, {'measure': 'Post-op pain assessment', 'timeFrame': 'post-op 48hrs', 'description': 'Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)'}, {'measure': 'Female Sexual Function Index (FSFI) questionnaire', 'timeFrame': 'post-op 5 months', 'description': 'Assessment Domain: Desire/ Arousal/ Lubrication/ Orgasm/ Satisfaction/ Pain Full scale score range: min 2.0 - max 36'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['natural orifice specimen extraction', 'laparoscopic surgery', 'transvaginal', 'female'], 'conditions': ['Urologic Neoplasms']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Study design:\n\nThis is a prospective, randomized, single center trial. This clinical trial was approved by the Institutional Review Boards.\n\nStudy process:\n\nAll 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.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are accessible with vaginal approach\n* Patients scheduled for laparoscopic resection of kidney for benign or malignant diseases\n* Patients with normal cervical cancer screening tests within the last 3 years except inflammatory findings\n\nExclusion Criteria:\n\n* Patients without sexual intercourse\n* Patients who are considered unable to remove specimen through vagina due to narrow introitus in gynecological examination\n* Patients who are expected to have severe adhesion due to deep infiltrative endometriosis or previous pelvic surgery history\n* Patients with abnormal cervical cancer screening tests\n* Patients scheduled to perform concomitant hysterectomy'}, 'identificationModule': {'nctId': 'NCT05135520', 'briefTitle': 'Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'A Prospective Randomized Controlled Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen (STTELS)', 'orgStudyIdInfo': {'id': 'SNUBH B-2105-687-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transabdominal specimen extraction', 'description': 'The outcomes of transabdominal specimen extraction in a classic way in patients who underwent multiport laparoscopic surgery for resection of kidney', 'interventionNames': ['Procedure: Transabdominal specimen extraction']}, {'type': 'EXPERIMENTAL', 'label': 'Transvaginal natural orifice specimen extraction (NOSE)', 'description': 'The outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who underwent multiport laparoscopic surgery for resection of kidney', 'interventionNames': ['Procedure: Transvaginal natural orifice specimen extraction (NOSE)']}], 'interventions': [{'name': 'Transvaginal natural orifice specimen extraction (NOSE)', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['Transvaginal natural orifice specimen extraction (NOSE)']}, {'name': 'Transabdominal specimen extraction', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['Transabdominal specimen extraction']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}