Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT06817460
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2024-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study Comparing the Effectiveness and Safety of Three Surgical Pathways for Laparoscopic Total Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2024-04-21', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of ERAS composite indexes within 24 hours after surgery', 'timeFrame': '(1) 6 hours after surgery; (2) 24 hours after surgery; (3) 48 hours after surgery', 'description': 'Including: (1) postoperative liquid diet, (2) anal exhaust, (3) self-urination after catheter removal, (4) getting out of bed, (5) visual analogue scale (VAS) score ≤3'}], 'secondaryOutcomes': [{'measure': 'Operation time', 'timeFrame': 'The operation time is measured in minutes from the beginning of the skin (or vaginal) incision to the completion of the skin (or vaginal) suture', 'description': 'duration of surgery'}, {'measure': 'intraoperative blood loss', 'timeFrame': 'The operation time is measured in minutes from the beginning of the skin (or vaginal) incision to the completion of the skin (or vaginal) suture', 'description': 'intraoperative blood loss'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hysterectomy', 'single-port', 'multi-port', 'enhanced recovery after surgery'], 'conditions': ['Benign Tumor of Uterus', 'Surgical Approaches', 'Enhanced Recovery After Surgery']}, 'descriptionModule': {'briefSummary': 'To explore the achievement of ERAS composite indexes within 24 hours after the operation of transumbilical single-hole laparoscopic total hysterectomy, transvaginal laparoscopic total hysterectomy and porous laparoscopic total hysterectomy.', 'detailedDescription': 'To explore the achievement of ERAS composite indexes within 24 hours after the operation of transumbilical single-hole laparoscopic total hysterectomy, transvaginal laparoscopic total hysterectomy and porous laparoscopic total hysterectomy.To explore the differences of operation time, intraoperative blood loss, intraoperative conversion mode and postoperative complication rate of three surgical paths: transumbilical single-hole laparoscopic total hysterectomy, transcolposcopic total hysterectomy and porous laparoscopic total hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-60 females\n* Total hysterectomy indications (uterine fibroids, adenomyosis, cervical precancerous lesions, endometrial dysplasia, cervical carcinoma in situ), total hysterectomy is planned\n* The patients who participated in the study recognized three surgical paths and were willing to accept any of the three at random\n* Be able to understand the research program and voluntarily participate in the research, and sign the informed consent\n* Good compliance, able to cooperate with and provide corresponding clinical information\n* Complete imaging and pathological clinical data;\n* General condition: ECOG≤1; 0 The activity capacity is completely normal, and there is no difference between the activity capacity and that before the onset of the disease; 1 Can move about freely and engage in light physical activity, including general household or office work, but cannot engage in heavy physical activity.\n\nExclusion Criteria:\n\n* asexual life history\n* The cyst needs to be removed at the same time or there are other vulvar, vaginal, appendix and other lesions, and surgical intervention is required at the same time\n* Malignant tumors or highly suspected malignant tumors\n* History of two or more pelvic surgeries, severe pelvic adhesions(triad examination suspected rectal endometriosis, or poor intrauterine mobility)\n* History of peritoneal dialysis, pelvic radiotherapy, and previous history of pelvic laparoscopic tuberculosis\n* the uterus is greater than 3 months of pregnancy or the maximum meridian of the uterus is greater than 12cm according to ultrasound (either of the two conditions can be excluded)\n* Diabetic patients with unsatisfactory blood sugar control\n* BMI\\>30Kg/m2\n* History of severe mental illness and brain dysfunction\n* A history of drug abuse or use\n* Patients with poor compliance or who are too far away for adequate follow-up'}, 'identificationModule': {'nctId': 'NCT06817460', 'briefTitle': 'A Clinical Study Comparing the Effectiveness and Safety of Three Surgical Pathways for Laparoscopic Total Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'A Single Center, Randomized, Single Blind, Parallel Controlled Clinical Study Comparing the Effectiveness and Safety of Three Surgical Pathways for Laparoscopic Total Hysterectomy', 'orgStudyIdInfo': {'id': '2024105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Observation group1', 'description': 'tran-sumbilical laparoendoscopic single-site surgery', 'interventionNames': ['Procedure: tran-sumbilical laparoendoscopic single-site surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Observation group2', 'description': 'transvaginal natural orifice transluminal endoscopic surgery', 'interventionNames': ['Procedure: transvaginal natural orifice transluminal endoscopic surgery']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'conventional three-port totaI laparoscopic hysterectomy'}], 'interventions': [{'name': 'tran-sumbilical laparoendoscopic single-site surgery', 'type': 'PROCEDURE', 'description': 'Different types of surgery', 'armGroupLabels': ['Observation group1']}, {'name': 'transvaginal natural orifice transluminal endoscopic surgery', 'type': 'PROCEDURE', 'description': 'Different types of surgery', 'armGroupLabels': ['Observation group2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}