Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-01-09 @ 12:57 PM
Study NCT ID:
NCT01564602
Status:
UNKNOWN
Last Update Posted:
2012-04-02
First Post:
2012-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009214', 'term': 'Myoma'}, {'id': 'D062788', 'term': 'Adenomyosis'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine 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': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-28', 'studyFirstSubmitDate': '2012-02-20', 'studyFirstSubmitQcDate': '2012-03-27', 'lastUpdatePostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The operative time', 'timeFrame': 'We will follow the patients until one month after the surgery.', 'description': 'We will follow the patients until one month after the surgery. The primary outcome measure of this trial is the effect and safety of single port-access laparoscopic-assisted vaginal hysterectomy.'}], 'secondaryOutcomes': [{'measure': 'weight of the uterus', 'timeFrame': 'one month'}, {'measure': 'blood loss', 'timeFrame': 'one month'}, {'measure': 'hospital length of stay', 'timeFrame': 'one month'}, {'measure': 'morbidity', 'timeFrame': 'one month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['2-channel single port laparoscopy', 'multiple-channel port laparoscopy'], 'conditions': ['Myoma', 'Adenomyosis']}, 'descriptionModule': {'briefSummary': 'The main objective of this trial is to assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The operative time, weight of the uterus, blood loss and hospital stay will be record, respectively. The pain score is based on the visual analogue scale in which patients record the intensity of their pain 12, 24, and 48 hours after surgery.', 'detailedDescription': 'Single port laparoscopy is an attempt to further enhance the cosmetic benefits of minimally invasive surgery while minimizing the potential morbidity associated with multiple incisions. Preliminary advances in LESS as applied to urologic and gastrointestinal surgery demonstrate that the techniques are feasible provided that both optimal surgical technical expertise with advanced skills and optimal instrumentation are available. Recently, Lee et al. performed the multiple channel single port-access laparoscopic-assisted vaginal hysterectomy (SPA-LAVH) in 24 patient. All cases but 3 were performed exclusively through a single port. The median operative time, weight of the uterus, and estimated blood loss were 119 minutes (range 90 to 255 minutes), 347 g (range 225 to 732 g), and 400 mL (range 100 to 1000 mL), respectively. The median hospital stay (postoperative day) was 3 days (range 3 to 7). Although there are a limited number of studies demonstrating the feasibility of single-port access laparoscopic-assisted vaginal hysterectomy (LAVH), single-port surgery is "new-old" (i.e., a revisited and unstandardized technique) because the major disadvantage of limited movement caused by collisions of the laparoscopic instruments has been mitigated by the development of multi-channel approaches. Therefore, the investigators used a 2-channel single-port system, which was different from the previously published 3-channel single-port technique11,12 to reduce collisions and aid the assistant in controlling the scope without interfering with the surgeon\'s instruments. To our knowledge, there are no randomize control trial to evaluate of 2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders. The purpose of this study was to assess the feasibility of 2-channel and multiple-channel single port laparoscopy in the treatment of benign uterine disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receive laparoscopic-assisted vaginal hysterectomy (LAVH)\n* American Society of Anesthesiologists (ASA) physical status of patient: classification I-II\n\nExclusion Criteria:\n\n* The procedure will be required to conversion to laparotomy.\n* Any cardio-vascular diseases.\n* Malignant disease'}, 'identificationModule': {'nctId': 'NCT01564602', 'briefTitle': 'To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Prospective Cohort Study to Compare to 2-channel and Multiple Channel Single Port Laparoscopic-assisted Vaginal Hysterectomy', 'orgStudyIdInfo': {'id': 'VGH2011-03-011IA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single port laparoscopic surgery', 'description': '2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders', 'interventionNames': ['Device: comparison multiple channel port laparoscopic surgery']}], 'interventions': [{'name': 'comparison multiple channel port laparoscopic surgery', 'type': 'DEVICE', 'otherNames': ['multiple channel port laparoscopic surgery'], 'description': 'to compare 2-channel single port and multiple channel port laparoscopic surgery', 'armGroupLabels': ['single port laparoscopic surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1121', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yi-Jen Chen, PHD', 'role': 'CONTACT', 'email': 'chenyj@vghtpe.gov.tw', 'phone': '886-2-28757566'}], 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yi-Jen Chen, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'vghtpe user', 'investigatorAffiliation': 'Taipei Veterans General Hospital, Taiwan'}}}}