Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-02-28 @ 11:51 PM
Study NCT ID:
NCT06421857
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2024-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemostatic Measures During Laparoscopic Cystectomy for Endometrioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2024-05-15', 'studyFirstSubmitQcDate': '2024-05-15', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ovarian reserve', 'timeFrame': '6 weeks after procedure', 'description': 'measuring AMH level'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrioma']}, 'descriptionModule': {'briefSummary': 'laparoscopic excision of ovarian endometriotic cysts is generally recommended because it has been associated with a higher spontaneous conception rate, residual ovarian function after the procedure may be affected'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 35 years\n* unilateral endometriotic cyst\n\nExclusion Criteria:\n\nanovulatory women women with decreased ovarian reserve women receiving hormonal treatment three months prior to surgery women with any contraindication to laparoscopy women with previous ovarian surgery possible ovarian malignancy.'}, 'identificationModule': {'nctId': 'NCT06421857', 'briefTitle': 'Hemostatic Measures During Laparoscopic Cystectomy for Endometrioma', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Bipolar Coagulation Versus Suturing During Laparoscopic Endometriotic Cystectomy', 'orgStudyIdInfo': {'id': 'ASU Hemostasis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'suturing', 'description': 'after ovarian cystectomy for endometrioma, separate sutures were applied if there was significant bleeding', 'interventionNames': ['Procedure: suturing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bipolar electrocoagulation', 'description': 'after ovarian cystectomy for endometrioma, the inner wall was coagulated using bipolar electrocoagulation if there was significant bleeding', 'interventionNames': ['Procedure: bipolar electrocoagulation']}], 'interventions': [{'name': 'suturing', 'type': 'PROCEDURE', 'description': 'laparoscopic cystectomy for endometrioma and hemostasis was done using suturing', 'armGroupLabels': ['suturing']}, {'name': 'bipolar electrocoagulation', 'type': 'PROCEDURE', 'description': 'laparoscopic cystectomy for endometrioma and hemostasis was done bipolar electrocoagulation', 'armGroupLabels': ['bipolar electrocoagulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Osama Kamel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'postgraduate student', 'investigatorFullName': 'Nagat Hesham Abdelhai Mohammed', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}