Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-02 @ 1:58 AM
Study NCT ID:
NCT02524756
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
2015-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-02', 'studyFirstSubmitDate': '2015-08-12', 'studyFirstSubmitQcDate': '2015-08-13', 'lastUpdatePostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1', 'timeFrame': '1 month', 'description': 'Duration of postoperative catheterization untill PVR urine volume is less than 100 ml'}], 'secondaryOutcomes': [{'measure': 'Intraoperative complications', 'timeFrame': 'During Surgery', 'description': 'intraoperative complications'}, {'measure': 'Blood loss', 'timeFrame': 'Day of surgery', 'description': 'Amount of blood intraoperative blood loss in ml. units'}, {'measure': 'Operative time', 'timeFrame': 'Day of surgery', 'description': 'Minutes for the surgical intervention'}, {'measure': 'Early postoperative complication', 'timeFrame': '30 days', 'description': 'Occurence of early postoperative complication within 30 days of operation'}, {'measure': 'Late postoperative complication', 'timeFrame': 'more than 30 days postoperative', 'description': 'complications related to surgery more than 30 days postoperative'}, {'measure': 'Bladder training exercise', 'timeFrame': '1 month', 'description': 'Removal of urinary catheter on the 3rd day postoperative without prior bladder training exercise and measurement of PVR urine volume'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nerve sparing radical hysterectomy'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': "The aim of this study is to assess:\n\n1. Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type III/C1 as regard surgical technique, blood loss and operative time.\n2. Evaluate patients' outcome as regard bladder function.\n\nin order to preserve the function of the bladder and the rectum, it is necessary to modify the traditional procedures, so as to identify the precise anatomical information directing the technique for optimal preservation of bladder function at the time of radical hysterectomy.\n\nThe laparoscopic technique offers several well-known advantages. Under the magnified view of the laparoscope, the anatomy can be clearly visualized to allow for the meticulous and precise dissection of the para-cervical structures and areolar tissue, including the blood vessels and the nerves.\n\nLaparoscopic identification (neurolysis) of the inferior hypogastric nerve and inferior hypogastric plexus is a feasible procedure for trained laparoscopic surgeons who have a good knowledge not only of the retroperitoneal anatomy but also of the pelvic neuro-anatomy as this qualification could prohibit long-term bladder and voiding dysfunction during nerve-sparing radical hysterectomy"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. Karnofsky \\> 80, or American Society of anaethesiology (ASA) I-II\n3. Stage IA2-IB1-IB2-IIA1-IIA2-IIB cervical cancer according to FIGO (International Federation of Gynecology and Obstetrics) staging.\n4. Stage II, III endometrial cancer\n\nExclusion Criteria:\n\n1. Non Invasive Cancer\n2. Pregnancy\n3. Bladder dysfunction detected prior to surgery.\n4. Previous pelvic lymphadenectomy.\n5. Tumour recurrence\n6. Incomplete surgery, unresectable lesion.'}, 'identificationModule': {'nctId': 'NCT02524756', 'briefTitle': 'Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy', 'orgStudyIdInfo': {'id': 'LNS-RH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group (A)', 'description': 'laparoscopic nerve sparing radical hysterectomy type III/C1', 'interventionNames': ['Procedure: laparoscopic nerve-sparing radical hysterectomy-type III/C1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group (B)', 'description': 'laparoscopic radical hysterectomy type III/C2', 'interventionNames': ['Procedure: laparoscopic radical hysterectomy (type III/C2).']}], 'interventions': [{'name': 'laparoscopic nerve-sparing radical hysterectomy-type III/C1', 'type': 'PROCEDURE', 'armGroupLabels': ['Group (A)']}, {'name': 'laparoscopic radical hysterectomy (type III/C2).', 'type': 'PROCEDURE', 'armGroupLabels': ['Group (B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'zip': '00168', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Largo Agostino Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Khaled Gaballa, MS.c.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Lecturer of surgical oncology, Mansoura universitry'}, {'name': 'Adel Taha Denewar, M.D., Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of surgical oncology department, Mansoura oncology centre, Mansoura university'}, {'name': 'Giovanni Scambia, M.D.,Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the Department for Woman and Unborn Life Health Care- Catholic University of the Sacred Heart- Rome, Italy'}, {'name': 'Valerio Gallotta, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Gynecologic Oncology,Catholic University of the Sacred Heart,Rome,Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osama Mohammad Ali ElDamshety', 'class': 'OTHER'}, 'collaborators': [{'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'surgical oncology', 'investigatorFullName': 'Osama Mohammad Ali ElDamshety', 'investigatorAffiliation': 'Mansoura University'}}}}