Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-28 @ 5:55 AM
Study NCT ID:
NCT06325592
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2024-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Surgical Timing and Route of Total Hysterectomy After LEEP and Perioperative Risk in Patients With Cervical HSIL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}], 'ancestors': [{'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 826}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-03-15', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative fever', 'timeFrame': 'Within 7 days of surgery', 'description': 'Use a thermometer to measure your temperature'}, {'measure': 'Postoperative therapeutic use of antibiotics', 'timeFrame': 'Within 7 days of surgery', 'description': 'Postoperative therapeutic use of antibiotics'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'Within 7 days of surgery', 'description': 'Postoperative complications'}, {'measure': 'Postoperative hospitalization days', 'timeFrame': 'Date of surgery to date of discharge', 'description': 'Postoperative hospitalization days'}, {'measure': 'Postoperative hemoglobin', 'timeFrame': 'Within 7 days of surgery', 'description': 'Postoperative hemoglobin'}, {'measure': 'Postoperative white blood cell count', 'timeFrame': 'Within 7 days of surgery', 'description': 'Postoperative white blood cell count'}, {'measure': 'Postoperative erythrocyte count', 'timeFrame': 'Within 7 days of surgery', 'description': 'Postoperative erythrocyte count'}, {'measure': 'Postoperative albumin number', 'timeFrame': 'Within 7 days of surgery', 'description': 'Postoperative albumin number'}, {'measure': 'Postoperative CRP value', 'timeFrame': 'Within 7 days of surgery', 'description': 'Postoperative CRP value'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High-Grade Squamous Intraepithelial Lesions']}, 'descriptionModule': {'briefSummary': 'This study aimed to analyze perioperative information in patients with high-grade squamous intraepithelial lesion (HSIL) undergoing total hysterectomy (TH), offering insights into optimal surgery timing, selecting the operation path, and enhancing surgical operation details.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Data were collected from patients with HSIL who underwent TH at the Gynecological Oncology Center of Sichuan Cancer Hospital between January 1, 2016, and October 31, 2023. Patients who underwent laparoscopic hysterectomy (LH) +/- bilateral fallopian tubes or bilateral adnexectomy for benign gynecological diseases (such as uterine fibroids and adenomyosis) were included in the control group (excluding patients with recent invasive operations of the cervix and vagina).', 'genderDescription': 'Gynecological patient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients were confirmed with HSIL through pathology at our hospital or another tertiary facility, with additional confirmation via pathological consultation at our facility;\n* LH or abdominal hysterectomy (AH) +/- bilateral fallopian tube or bilateral adnexectomy was performed after LEEP;\n* the patient had no history of systemic malignancies.\n\nExclusion Criteria:\n\n* severe medical and surgical complications;\n* an extensive or subextensive hysterectomy was performed;\n* surgical removal scope involving tissues (such as lymph nodes) or organs (such as the appendix) other than the uterus, ovaries, and fallopian tubes;\n* fever symptoms within the last month;\n* incidence of pelvic and abdominal infections, vaginitis, or similar conditions within the past month.'}, 'identificationModule': {'nctId': 'NCT06325592', 'briefTitle': 'Association Between Surgical Timing and Route of Total Hysterectomy After LEEP and Perioperative Risk in Patients With Cervical HSIL', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan Cancer Hospital and Research Institute'}, 'officialTitle': 'Association Between Surgical Timing and Route of Total Hysterectomy After Loop Electrosurgical Excision Procedure and Perioperative Risk in Patients With Cervical High-grade Squamous Intraepithelial Lesion', 'orgStudyIdInfo': {'id': 'REHSIL2023V1.1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1', 'description': 'patients underwent laparoscopic hysterectomy within 3 days after LEEP', 'interventionNames': ['Procedure: surgical timing and operation path']}, {'label': 'group 2', 'description': 'patients underwent abdominal hysterectomy within 3 days after LEEP', 'interventionNames': ['Procedure: surgical timing and operation path']}, {'label': 'group 3', 'description': 'patients underwent laparoscopic hysterectomy 4 weeks after LEEP', 'interventionNames': ['Procedure: surgical timing and operation path']}, {'label': 'group 4', 'description': 'underwent abdominal hysterectomy 4 weeks after LEEP', 'interventionNames': ['Procedure: surgical timing and operation path']}, {'label': 'control group', 'description': 'Patients who underwent laparoscopic hysterectomy (LH) due to benign gynecological diseases were included in the control group.'}], 'interventions': [{'name': 'surgical timing and operation path', 'type': 'PROCEDURE', 'description': 'surgical timing; laparoscopic hysterectomy or abdominal hysterectomy', 'armGroupLabels': ['group 1', 'group 2', 'group 3', 'group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Sichuan Cancer Hospital and Research Institute', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Dengfeng Wang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sichuan Cancer Hospital and Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Cancer Hospital and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the first ward of Gynecology Oncology Department', 'investigatorFullName': 'Dengfeng Wang', 'investigatorAffiliation': 'Sichuan Cancer Hospital and Research Institute'}}}}