Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-02 @ 1:24 AM
Study NCT ID:
NCT03989856
Status:
UNKNOWN
Last Update Posted:
2019-06-18
First Post:
2019-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Laparoscopic Suturing Versus Bipolar Coagulation on Ovarian Reserve in Patients Undergoing Endometriotic Ovarian Cystectomy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Allocation and concealment will be done by sequentially sealed opaque envelopes. 60 envelopes will be numbered serially from 1 to 60, 30 envelopes will contain the letter c and the other 30 will contain the letter S.\n\nIn each envelope, the corresponding letter which donates the allocated group will be put according to the randomization table and them all envelopes will be closed and put in one box. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study population comprises females in childbearing period underwent laparoscopic ovarian cystectomy at Ain Shams University Maternity Hospital, Obstetric and Gynecology Department, Faculty of medicine.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-17', 'studyFirstSubmitDate': '2019-06-15', 'studyFirstSubmitQcDate': '2019-06-17', 'lastUpdatePostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ovarian reserve', 'timeFrame': '3 months', 'description': 'By measuring Anti-mullerian hormone'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovary Injury']}, 'descriptionModule': {'briefSummary': 'In women undergoing laparoscopic ovarian cystectomy which is less harmfull on the ovarian reserve (electrocoagulation or suturing).', 'detailedDescription': 'The aim of the present study was to determine which hemostatic procedure (hemostatic suture or electrocautery) may be less harmful after laparoscopic cystectomy, based on the longterm status of the ovarian reserve.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18- 45.\n2. Regular menstrual cycle.\n3. Unilateral ovarian cyst clinical \\& us finding as endometriotic cyst.\n4. C/O of pelvic pain.\n5. No medications (oral pills \\& hormonal drugs) in the past 3 monthes before enrollement.\n6. No evidence of endocrine disorders (DM, Thyroid dysfunction,hyper prolactenemia, congenital adrenal hyperplesia, cushing's syndrome or adrenal insufficiency)\n7. No previous adnexial surgery.\n8. Pathology diagnosis of excised ovarian tissue (endometriotic cyst)\n9. Appropriate medical condition for laparoscopic surgery.\n10. Completely understand the process of the study with written consent.\n\nExclusion Criteria:\n\n1. PCO according to Rotterdam criteria.\n2. Pathological diagnosis of excised ovarian tissue as non endometriotic cyst.\n3. Previous ovarian surgery.\n4. Suspected ovarian malignancy.\n5. Patient whose histopathology showed benign cyst apart from endometrioma.\n6. Irregular menstrual cycles.\n7. Post menopausal status.\n8. Bilateral ovarian cyst.\n9. AMH \\< 0.5 ng/ml.\n10. Premature ovarian failure in family."}, 'identificationModule': {'nctId': 'NCT03989856', 'acronym': 'Eolsb', 'briefTitle': 'Effect of Laparoscopic Suturing Versus Bipolar Coagulation on Ovarian Reserve in Patients Undergoing Endometriotic Ovarian Cystectomy.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of Laparoscopic Suturing Versus Bipolar Coagulation on Ovarian Reserve in Patients Undergoing Endometriotic Ovarian Cystectomy.', 'orgStudyIdInfo': {'id': '123456789'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suturing group', 'description': 'The sutures will be performed with intracorporeal knots using 2-0 polyglican absorbable sutures (Vicryl; Ethicon Inc., New Jersey, USA). Suture is performed using needle holders for the closure of ovarian parenchyma and controlling bleeding. Bleeding from ovarian hilus will only resolve by suturing.\n\nThe running suture starting from central area, around the ovarian hilus to peripheral tissue, will be performed with intraovarian knots to re-approximate the edges to achieve satisfying hemostasis. Knots will not be detectable on the ovarian surface for prevention of adhesion. Mean time for hemostasis of ovary was recorded in a form. The cyst wall will be removed from the abdomen by means of an endobag. All resected cyst walls will be sent to the pathology laboratory, to confirm the histopathology of endometriosis.', 'interventionNames': ['Device: 2-0 polyglican absorbable sutures']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bipolar group', 'description': 'In bipolar coagulation group, after stripping the ovarian cyst wall, bipolar coagulation technique will be used to control significant bleeding (40 W current; Richard Wolf, Germany). In laparoscopic suturing group, no bipolar coagulation will be performed during or after stripping the ovarian cyst wall.', 'interventionNames': ['Device: Diathermy']}], 'interventions': [{'name': '2-0 polyglican absorbable sutures', 'type': 'DEVICE', 'description': 'The sutures will be performed with intracorporeal knots using 2-0 polyglican absorbable sutures (Vicryl; Ethicon Inc., New Jersey, USA). Suture is performed using needle holders for the closure of ovarian parenchyma and controlling bleeding. Bleeding from ovarian hilus will only resolve by suturing.', 'armGroupLabels': ['Suturing group']}, {'name': 'Diathermy', 'type': 'DEVICE', 'description': 'bipolar coagulation technique will be used to control significant bleeding (40 W current; Richard Wolf, Germany). I', 'armGroupLabels': ['Bipolar group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'state': 'Abbasia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed abd elfatah elsenity, lecturer', 'role': 'CONTACT', 'email': 'm.elsenity@yahoo.com', 'phone': '00201226573332'}, {'name': 'Ahmed Yousef riad, M.B.B.CH', 'role': 'CONTACT', 'email': 'Ahmedriadaboelnaga90@gmail.com', 'phone': '002010'}], 'facility': 'Ain shams maternity teaching hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Abd elfatah el senity, Lecturer', 'role': 'CONTACT', 'email': 'M.elsenity@yahoo.com', 'phone': '+201226573332'}, {'name': 'Ahmad Yousef riad, M.B.B.C.H', 'role': 'CONTACT', 'email': 'ahmedriadaboelnaga90@gmail.com', 'phone': '+201093151434'}], 'overallOfficials': [{'name': 'Mohamed Abd elfattah elsenitt, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of obstetrics and gynecology', 'investigatorFullName': 'Mohamed abd elfatah elsenity', 'investigatorAffiliation': 'Ain Shams University'}}}}