Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 1:07 AM
Study NCT ID:
NCT07330102
Status:
COMPLETED
Last Update Posted:
2026-01-09
First Post:
2025-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systematic Approach for Cold Knife Morcellation of Large Uterus in Total Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069577', 'term': 'Morcellation'}], 'ancestors': [{'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-29', 'studyFirstSubmitDate': '2025-12-29', 'studyFirstSubmitQcDate': '2025-12-29', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of operation', 'timeFrame': 'At time of surgery', 'description': 'Total time of the operation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hysterectomy', 'Morcellation', 'Large uterus'], 'conditions': ['Hysterectomy, Benign Uterine Diseases']}, 'descriptionModule': {'briefSummary': 'Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri. The cervix is guided through the colpotomy and is grasped vaginally with a tenaculum and pulled exteriorly. The vault is then closed with a continuous suture.', 'detailedDescription': 'Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri. The cervix is guided through the colpotomy and is grasped vaginally with a tenaculum and pulled exteriorly. The vault is then closed with a continuous suture.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women candidates for total laparoscopic hysterectomy\n* Uterus size \\>/= 20 weeks gravid uterus\n* Benign uterine disease\n\nExclusion Criteria:\n\n* • Malignant or premalignant uterine disease\n* Bleeding disorders\n* Unfit for surgery\n* Contraindications for laparoscopy'}, 'identificationModule': {'nctId': 'NCT07330102', 'briefTitle': 'Systematic Approach for Cold Knife Morcellation of Large Uterus in Total Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Systematic Approach for Cold Knife Morcellation of Large Uterus in Total Laparoscopic Hysterectomy', 'orgStudyIdInfo': {'id': '368'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Morecellation group', 'description': 'Morcellation of the large uterus', 'interventionNames': ['Procedure: Morcellation']}], 'interventions': [{'name': 'Morcellation', 'type': 'PROCEDURE', 'description': 'Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri.', 'armGroupLabels': ['Morecellation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12111', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Maged', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ahmed M Maged, MD', 'investigatorAffiliation': 'Cairo University'}}}}