Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-01 @ 9:29 AM
Study NCT ID:
NCT03901404
Status:
COMPLETED
Last Update Posted:
2022-06-23
First Post:
2019-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myomectomy Operation and Fundus Incision, Energy Modalities and Methods of Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fundus Incision', 'timeFrame': '3 months', 'description': 'In patients undergoing myomectomy, the incision used by the surgeon will be recorded to remove myoma. to be recorded as transverse or vertical.'}, {'measure': 'Energy Modalities', 'timeFrame': '3 months', 'description': 'In patients undergoing myomectomy, the energy modality used by the surgeon will be recorded to remove the myoma.\n\nbipolari, monopolar or ultrasonic'}, {'measure': 'Methods of Extraction', 'timeFrame': '3 months', 'description': 'In patients undergoing myomectomy operation, the method used by the surgeon to remove myoma from the abdomen will be recorded.\n\nmorselator, vaginally with colpotomi'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myomectomy', 'Fundus Incision', 'Energy Modalities', 'Methods of Extraction'], 'conditions': ['Myoma;Uterus', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Myomectomy operation due to myoma uteri is an operation that can cause serious blood loss. For some anatomical reasons, fundal myomas were removed, while a group of investigators recommended the initiation of a longitudinal incision and some surgeons preferred a transverse incision. the authors aim to show some surgical differences, intraoperative blood loss, and difficulties and ease of removal of myoma in patients with these approaches without consensus. It is also noted that the incision made with the same energy modality is recorded; The effect of energy modality on blood loss and surgical comfort will be examined. Different approaches are used for laparoscopic surgical operations in order to remove myoma from the abdomen. It can be removed from the vagina by colpotomy and can also be minimized in the abdomen by a morselator. In particular, patients with vaginal myoma removed, such as complaints of postoperative dyspareunia will be followed. In this way, the investigators aim to evaluate the methods which have not yet gained clarity in the literature or have not proven superiority to each other.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients operated with the diagnosis of myoma uteri', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients operated with the diagnosis of myoma uteri\n\nExclusion Criteria:\n\n* Cardiopulmonary diseases such as cardiac insufficiency, myocardial infarction, unstable angina, acute or new vascular thrombosis, asthma or pulmonary obstructive disease;\n* Patients with long-term Trendelenburg contraindications;\n* Previous pelvic or abdominal radiation therapy; or those with inadequate bone marrow, kidney and hepatic function;\n* Gynecological malignancies.\n* Those who received preoperative medication due to myoma uteri'}, 'identificationModule': {'nctId': 'NCT03901404', 'briefTitle': 'Myomectomy Operation and Fundus Incision, Energy Modalities and Methods of Extraction', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Used During Myomectomy Operation; Comparison of Fundus Incision, Energy Modalities and Methods of Extraction', 'orgStudyIdInfo': {'id': '2018.12.67'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Myomectomy Operation', 'type': 'PROCEDURE', 'description': 'Patients undergoing myomectomy for myoma uteri'}]}, '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': 'principal investigator, M.D, Department of Obstetrics and GynecologyR', 'investigatorFullName': 'Pınar Kadirogulları', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}