Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-01-01 @ 10:10 PM
Study NCT ID:
NCT05823935
Status:
UNKNOWN
Last Update Posted:
2023-04-21
First Post:
2023-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014591', 'term': 'Uterine Diseases'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-09', 'studyFirstSubmitDate': '2023-04-09', 'studyFirstSubmitQcDate': '2023-04-09', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total operative time', 'timeFrame': 'From start to end of operation', 'description': 'The time between placement of the operative ports and successful closure of the vaginal cuff'}, {'measure': 'Operative time for colpotomy and vaginal cuff closure', 'timeFrame': 'From start colpotomy to end of vaginal cuff closure', 'description': 'The time between first anchor suture placement and successful closure of the vaginal cuff'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TLH', 'Bakay purse string'], 'conditions': ['Uterine Diseases']}, 'descriptionModule': {'briefSummary': 'To compare vaginal cuff closure via Bakay purse string with vaginal cuff closure via vaginal route with continuous locked suturing after total laparoscopic hysterectomy for benign lesions.', 'detailedDescription': 'The objective of the present study is to compare 2 different methods for vaginal cuff closure after total laparoscopic hysterectomy for benign lesions regarding operative time, vaginal length, vaginal cuff dehiscene, hematoma formation. The first method is the Bakay purse string and the second is the closure of the vault via vaginal route with continuous locked suturing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Benign uterine lesions e.g fibroid, adenomyosis,…etc.\n* Patient acceptance to undergo laparoscopic hysterectomy.\n\nExclusion Criteria:\n\n* Gynecological malignancy.\n* Low corporeal myoma obsecuring cervicovaginal junction.\n* History of extensive abdominal surgery other than cesarean section.'}, 'identificationModule': {'nctId': 'NCT05823935', 'briefTitle': 'Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Laparoscopic Versus Vaginal Cuff Closure During Laparoscopic Hysterectomy in Benign Gynecological Lesions', 'orgStudyIdInfo': {'id': 'MD.22.10.703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bakay purse string group', 'description': 'Bakay purse string will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions.', 'interventionNames': ['Procedure: Bakay purse string']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cuff closure via vaginal route group', 'description': 'Vaginal cuff closure via vaginal route with continuous locked suturing will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions.', 'interventionNames': ['Procedure: Cuff closure via vaginal route group']}], 'interventions': [{'name': 'Bakay purse string', 'type': 'PROCEDURE', 'description': "After developing the bladder flap, Vicryl polyglactin 910 sutures (Ethicon, Inc, Somerville, NJ) will be placed on the line between the cervicovaginal junction and the bladder starting at either 4 to 3 o'clock or 8 to 9 o'clock, as anchor sutures. Paying attention not to get closer than 1 cm to the bladder, the first suture will be passed from 4 o'clock to 3 o'clock and continued circumferentially in a full-thickness purse string fashion through 3, 1, 10, 8, 7, 5 o'clock completing a circle while including both uterosacral ligaments.", 'armGroupLabels': ['Bakay purse string group']}, {'name': 'Cuff closure via vaginal route group', 'type': 'PROCEDURE', 'description': 'After the uterus will be removed via vaginal route, vaginal cuff ends will be grasped via vaginal approach and sutured continuous locked sutures using Vicryl polyglactin 910 sutures in one layer.', 'armGroupLabels': ['Cuff closure via vaginal route group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Obstetrics and Gynecology Department in Mansoura University Hospital', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Ahmed M Elashry, MSc', 'role': 'CONTACT', 'email': 'elashry11090@gmail.com', 'phone': '+201066556370'}, {'name': 'Mohamed S Abdelhafez, MD', 'role': 'CONTACT', 'email': 'msabdelhafez@gmail.com'}], 'overallOfficials': [{'name': 'Ahmed M Elashry, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}, {'name': 'Hamed M Youssef, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University'}, {'name': 'Maged R Elshamy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}, {'name': 'Mahmoud M Awad, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}, {'name': 'Mohamed S Abdelhafez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}