Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-05 @ 6:03 PM
Study NCT ID:
NCT04410393
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-18
First Post:
2020-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sacrocolpopexy and Lateral Suspension Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011391', 'term': 'Prolapse'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence', 'timeFrame': '1 years', 'description': 'Patients will be followed up for 1 year after surgery and will be evaluated for recurrence at 1, 6 and 12 months.\n\ndegree of uterine desensus cystocele and rectocele degree to be examined Recurrence rate will be defined by pelvic examination according to POP-Q scoring.'}, {'measure': 'complications', 'timeFrame': '1 years', 'description': 'Patients will be followed up for 1 year after the operation and will be evaluated for complications at 1, 6 and 12 months.\n\nbleeding ( bleeding rate will be specified in milliliters ) the risk of infection (According to the findings, there is an infection with / without infection.)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sacrocolpopexy', 'Lateral Suspension'], 'conditions': ['Prolapse', 'Cuff']}, 'descriptionModule': {'briefSummary': 'Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign reasons. One of these is sacrocolpopexy and the other is lateral suspension. the investigators want to compare the results of patients undergoing these two operations. Thus, the difference between surgical methods will be investigated.', 'detailedDescription': 'Patients with symptomatic vaginal cuff prolapse will be operated; There will be two kinds of operation. After the operations, the patients will be followed up, a questionnaire will be applied to the postoperative patients and some questions will be asked. Pelvic examinations will also be performed and they will be evaluated for recurrence and complication. At the end of the study, the data of both groups will be compared and their superiority to each other will be shown.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign reasons. One of these is sacrocolpopexy and the other is lateral suspension. The investigators will form study groups of patients who underwent these two operations.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had previously undergone hysterectomy for benign causes\n* Patients with symptomatic vaginal cuff prolapse during hysterectomy follow-up\n* And for this, patients scheduled for operation\n\nExclusion Criteria:\n\n* Patients with chronic diseases or medications that interfere with the operation\n* Patients with oncology operated for malignant cause\n* Non-localized patients with vaginal cuff prolapse'}, 'identificationModule': {'nctId': 'NCT04410393', 'briefTitle': 'Sacrocolpopexy and Lateral Suspension Operations', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Comparison of the Sacrocolpopexy Operation and Lateral Suspension Operations Performed in the Treatment of Vaginal Cuff Prolapse in Patients With Hysterectomized Patients', 'orgStudyIdInfo': {'id': 'ATADEK- 2020/06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sacrocolpopexy patients', 'description': 'Patients who underwent sacrocolpopexy for the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign causes', 'interventionNames': ['Procedure: vaginal cuff prolapse surgery']}, {'label': 'lateral suspension surgery patients', 'description': 'Patients who underwent lateral suspension surgery for vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign causes', 'interventionNames': ['Procedure: vaginal cuff prolapse surgery']}], 'interventions': [{'name': 'vaginal cuff prolapse surgery', 'type': 'PROCEDURE', 'description': 'Different surgical methods for the treatment of vaginal cuff prolapse in patients who have previously undergone hysterectomy for benign causes', 'armGroupLabels': ['lateral suspension surgery patients', 'sacrocolpopexy patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33404', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Süleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator', 'investigatorFullName': 'Pınar Kadirogulları', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}