Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-01-17 @ 3:12 AM
Study NCT ID:
NCT02841059
Status:
UNKNOWN
Last Update Posted:
2017-02-23
First Post:
2016-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pelvic Floor Function and Sexual Life of the Women After Different Type of Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'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': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-07-19', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life change', 'timeFrame': 'up to 12 months after hysterectomy', 'description': 'Evaluate the change of quality of life by questionaire --WHOQOL-BREF Taiwan version, at preoperation,1,3,6 and 12 months after hysterectomy.'}], 'secondaryOutcomes': [{'measure': 'Pelvic organ prolapse change', 'timeFrame': 'up to 24 months after hysterectomy', 'description': 'evaluate by Pelvic Organ Prolapse Quantification System (POP-Q) at preoperation, 6,12 and 24 months after hysterectomy.'}, {'measure': 'Urinary disorders change', 'timeFrame': 'preoperation and 3,6 and 12 months after hysterectomy', 'description': 'evaluate by UDI-6 short form at preoperation,3,6 and 12 months after hysterectomy.'}, {'measure': 'Sexual life change', 'timeFrame': 'preoperation and 3,6 and 12 months after hysterectomy', 'description': 'short form of PISQ-9 approved by International Urogynecological Association, IUGA, at preoperation,3,6 and 12 months after hysterectomy.'}, {'measure': 'Urinary incontinence status change', 'timeFrame': 'preoperation and 3,6 and 12 months after hysterectomy', 'description': 'evaluate by IIQ-7 short form at preoperation,3,6 and 12 months after hysterectomy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['quality of life', 'urinary incontinence', 'POP'], 'conditions': ['Quality of Life', 'Urinary Incontinence', 'Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': 'In this prospective, comparative non-randomized multiple teaching hospitals study, the investigators try to determine the relationship of total hysterectomy and Taiwanese female pelvic floor and sexual function from the view of epidemiology and clinical survey. This is an important issue that related to female autonomy, health care resources and even national health policy. The study results will help to understand whether there is unnecessary part in the current hysterectomy procedures and its potential health hazard.', 'detailedDescription': 'Women with benign gynecology disease and indicated for laparoscopic hysterectomy (laparoscopic subtotal hysterectomy: LSH, laparoscopic cervical ligament sparing hysterectomy: CLSH, laparoscopic assisted vaginal hysterectomy: LAVH) are invited and explained the details of the protocol by the surgeon. The types of hysterectomy are determined by the patient and the surgeon together after discussion. All participant have to sign the informed consent. The participant will be followed up for two years after surgery. Preoperative evaluation on uterine condition, pelvic floor, questionaires were recorded. The perioperative parameters including surgical time, blood loss, and postoperative parameters such as pain score, hospitalization etc were recorded. The postoperative evaluation on pelvic floor condition, questionaires etc were also recorded at different time points.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patient who is indicated for hysterectomy due to benign gynecology disease. The participant's husband is also welcomed to join the survey of the sexual life questionnaire but this is not a necessary inclusion criteria.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient who is indicated for hysterectomy due to benign gynecology disease. The participant's husband is also welcomed to join the survey of the sexual life questionnaire but this is not a necessary inclusion criteria.\n\nExclusion Criteria:\n\n1. Suspect of or diagnosed as cancer patient\n2. Age \\< 30 or \\> 50 years old\n3. Menopausal woman or woman who is nulliparous\n4. Patient with advanced pelvic floor prolapse (stage 2, 3, 4) including uterine prolapse, cystocele, enterocele, rectocele.\n5. Patient with prominent urinary incontinence that affect social activity or suggested to have surgery by gynecologist or urologist.\n6. Patient with severe medical diseases such as liver cirrhosis, heart failure, poor control diabetes mellitus etc.\n7. Patient with severe pelvic inflammatory disease/tubo-ovarian abcess or pelvic endometriosis or history of severe pelvic adhesions.\n8. Psychiatric patients\n9. Patient with chronic lung disease such as bronchial asthma, bronchiectasis, chronic obstructive pulmonary disease and interstitial lung disease"}, 'identificationModule': {'nctId': 'NCT02841059', 'acronym': 'HYS-PF-QOL', 'briefTitle': 'The Pelvic Floor Function and Sexual Life of the Women After Different Type of Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Buddhist Tzu Chi General Hospital'}, 'officialTitle': 'The Association of Total Hysterectomy and Disorders of Female Pelvic Floor or Sexual Function: a Survey on Pelvic Floor Function and Sexual Life for Women After Different Type of Hysterectomy', 'orgStudyIdInfo': {'id': 'HYS-SEX-QOL-POP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laparoscopic subtotal hysterectomy', 'description': 'women with benign gynecology disease and decided to receive laparoscopic subtotal hysterectomy (LSH) after discussion with her surgeon.', 'interventionNames': ['Procedure: LSH']}, {'label': 'Laparoscopic CLSH', 'description': 'women with benign gynecology disease and decided to receive laparoscopic cervical ligament sparing hysterectomy (CLSH) after discussion with her surgeon.', 'interventionNames': ['Procedure: CLSH']}, {'label': 'Laparoscopic AVH', 'description': 'women with benign gynecology disease and decided to receive laparoscopic assisted vaginal hysterectomy (LAVH) after discussion with her surgeon.', 'interventionNames': ['Procedure: LAVH']}], 'interventions': [{'name': 'LSH', 'type': 'PROCEDURE', 'otherNames': ['laparoscopic subtotal hysterectomy: LSH'], 'description': 'laparoscopic subtotal hysterectomy: LSH', 'armGroupLabels': ['Laparoscopic subtotal hysterectomy']}, {'name': 'CLSH', 'type': 'PROCEDURE', 'description': 'laparoscopic cervical ligament sparing hysterectomy: CLSH', 'armGroupLabels': ['Laparoscopic CLSH']}, {'name': 'LAVH', 'type': 'PROCEDURE', 'description': 'laparoscopic assisted vaginal hysterectomy: LAVH', 'armGroupLabels': ['Laparoscopic AVH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62224', 'city': 'Chiayi City', 'state': 'Chiayi', 'country': 'Taiwan', 'facility': 'Dalin Tzu Chi Hospital', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}, {'zip': '970', 'city': 'Hualien City', 'state': 'Hualien', 'country': 'Taiwan', 'facility': 'Buddhist Tzu Chi General Hospital', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}, {'zip': '970', 'city': 'Hualien City', 'state': 'Hualien', 'country': 'Taiwan', 'facility': 'Mennonite Memorial Hospital', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}, {'zip': '23142', 'city': 'Taipei', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Tzu Chi Hospital'}], 'overallOfficials': [{'name': 'Mun-Kun Hong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics and Gynecology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Buddhist Tzu Chi General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}