Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT05113134
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2021-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D014565', 'term': 'Urogenital 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient and Observer Scar Assessment Scale (POSAS)', 'timeFrame': '8 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.'}], 'secondaryOutcomes': [{'measure': 'Female Sexual Function Index (FSFI) questionnaire', 'timeFrame': '6 months', 'description': 'Sexual function assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['natural orifice specimen extraction', 'laparoscopic surgery', 'transvaginal', 'Female'], 'conditions': ['Colorectal Neoplasms', 'Urologic Neoplasms', 'Gastrointestinal Neoplasms', 'Neoplasms by Site']}, 'referencesModule': {'references': [{'pmid': '31580003', 'type': 'RESULT', 'citation': 'Soyman Z, Kelekci S, Aydogmus S, Demirel E, Ekmekci E. Transabdominal versus transvaginal specimen extraction in mini-laparoscopic surgery. J Obstet Gynaecol Res. 2019 Dec;45(12):2400-2406. doi: 10.1111/jog.14134. Epub 2019 Oct 3.'}, {'pmid': '29333423', 'type': 'RESULT', 'citation': 'Park JS, Kang H, Park SY, Kim HJ, Lee IT, Choi GS. Long-term outcomes after Natural Orifice Specimen Extraction versus conventional laparoscopy-assisted surgery for rectal cancer: a matched case-control study. Ann Surg Treat Res. 2018 Jan;94(1):26-35. doi: 10.4174/astr.2018.94.1.26. Epub 2017 Dec 28.'}, {'pmid': '30792863', 'type': 'RESULT', 'citation': 'Guan X, Liu Z, Longo A, Cai JC, Tzu-Liang Chen W, Chen LC, Chun HK, Manuel da Costa Pereira J, Efetov S, Escalante R, He QS, Hu JH, Kayaalp C, Kim SH, Khan JS, Kuo LJ, Nishimura A, Nogueira F, Okuda J, Saklani A, Shafik AA, Shen MY, Son JT, Song JM, Sun DH, Uehara K, Wang GY, Wei Y, Xiong ZG, Yao HL, Yu G, Yu SJ, Zhou HT, Lee SH, Tsarkov PV, Fu CG, Wang XS; International Alliance of NOSES. International consensus on natural orifice specimen extraction surgery (NOSES) for colorectal cancer. Gastroenterol Rep (Oxf). 2019 Feb;7(1):24-31. doi: 10.1093/gastro/goy055. Epub 2019 Jan 23.'}, {'pmid': '36309743', 'type': 'DERIVED', 'citation': 'Hwang WY, Suh DH, Lee S. Cosmesis and feasibility of transvaginal natural orifice Specimen extraction (NOSE) for large organ specimen: a prospective pilot study. BMC Urol. 2022 Oct 29;22(1):165. doi: 10.1186/s12894-022-01114-4.'}]}, '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 solid organs including kidney, liver, stomach, adrenal gland and bladder.', 'detailedDescription': "Study design:\n\nThis was a prospective, single center, single arm study. 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. All participants underwent demographic and history taking, laboratory tests and a gynecological examination to determine whether specimen removal through vagina is possible. The patients who was adequate for this study were planned to perform multiport laparoscopic surgery and patients were subjected to transvaginal NOSE.\n\nTo perform transvaginal NOSE procedure, the patients were placed in the lithotomy position with Trendelenburg position. After about 1-2cm incision at the posterior vaginal fornix, endopouch was introduced into the abdominal cavity through vaginal incision site. The specimen was placed inside a endopouch and removed through vagina. Closure of vaginal incision site was achieved by transvaginally with 2/0 absorbable suture.\n\nDuring the second and third visit at 1 week and 8 week, Patient and Observer Scar Assessment Scale (POSAS) was performed to assess cosmetic outcomes of scar. Subjects with sexual activity carried out Female Sexual Function Index (FSFI) questionnaire to assess sexual function at final visit which occurred at 6 months after surgery.\n\nStatistical analysis:\n\nAll data are summarized as means ± standard deviation or as numbers with proportions. A p \\< 0.05 was considered to indicate significance. Student's t-test and Mann-Whitney U test were conducted to compare continuous parametric variables and non-parametric variables, respectively."}, '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 stomach, colon, kidney and spleen 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': 'NCT05113134', 'acronym': 'STTELS', 'briefTitle': 'Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'A Prospective Clinical Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen (STTELS)', 'orgStudyIdInfo': {'id': 'SNUBH B-1411-276-005'}}, 'armsInterventionsModule': {'armGroups': [{'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 solid organs including kidney, liver, stomach, adrenal gland and bladder', '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, liver, stomach, adrenal gland and bladder will undergo Transvaginal NOSE', 'armGroupLabels': ['Transvaginal natural orifice specimen extraction (NOSE)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}