Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-02-12 @ 2:20 PM
Study NCT ID:
NCT02011659
Status:
UNKNOWN
Last Update Posted:
2013-12-13
First Post:
2013-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D062788', 'term': 'Adenomyosis'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C071315', 'term': 'ramosetron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-12', 'studyFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2013-12-12', 'lastUpdatePostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence or intensity of PONV', 'timeFrame': 'during postoperative hospital stays (2 days)'}], 'secondaryOutcomes': [{'measure': 'Adverse reaction associated with Ramosetron injection', 'timeFrame': 'Postoperatvie 7 days (at OPD based)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ramosetron, postoperative nausea and vomiting, laparoscopy'], 'conditions': ['Uterine Myoma, Ovary Neoplasm, Adenomyosis']}, 'referencesModule': {'references': [{'pmid': '31538078', 'type': 'DERIVED', 'citation': 'Li SC, Wang Y, Choi SJ, Jung YS, Han KH, Chung IB, Lee SH. Scheduled injection of ramosetron for prevention of nausea and vomiting following single-port access total laparoscopic hysterectomy: a prospective randomized study. Obstet Gynecol Sci. 2019 Sep;62(5):344-351. doi: 10.5468/ogs.2019.62.5.344. Epub 2019 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic patients undergoing laparoscopic surgery after scheduled administration of intravenous Ramosetron during hospital stays.\n\n* Randomized controlled arm : Placebo versus Ramosetron injection\n* Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs after surgery', 'detailedDescription': 'Surgical outcomes including operative time, blood loss, Hb change, postoperative pain, nausea/vomiting scale, times of rescue therapy, and complications'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18\\< or =, = or \\<70 with benign gynecologic disease\n* ASA-Class I-II\n* No-definite malignancy by US, CT/MRI, CA 125 \\< 500IU/ml\n* Non-smoker\n\nExclusion Criteria:\n\n* Conversion to laparotomy\n* Hx of malignancy\n* Smoker\n* Suspicious malignancy'}, 'identificationModule': {'nctId': 'NCT02011659', 'acronym': 'PONV', 'briefTitle': 'Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': 'National Health Insurance Service Ilsan Hospital'}, 'officialTitle': 'A Randomized Prospective Study of Scheduled Intravenous Ramosetron for the Prevention of Nausea and Vomiting in Hospitalized Patients After Gynecologic Laparoscopy', 'orgStudyIdInfo': {'id': 'PONV-NHIS-GYN-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ramosetron', 'interventionNames': ['Drug: Ramosetron']}], 'interventions': [{'name': 'Ramosetron', 'type': 'DRUG', 'armGroupLabels': ['Ramosetron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-719', 'city': 'Goyang-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'San-Hui Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Health Insurance Service Ilsan Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'centralContacts': [{'name': 'San-Hui Lee, M.D.', 'role': 'CONTACT', 'email': 'sanaram@naver.com', 'phone': '+82-900-0218'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Health Insurance Service Ilsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical assistant professor', 'investigatorFullName': 'San-Hui Lee', 'investigatorAffiliation': 'National Health Insurance Service Ilsan Hospital'}}}}