Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT04900558
Status:
RECRUITING
Last Update Posted:
2021-05-25
First Post:
2021-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Robotic Radical Cystectomy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015653', 'term': 'Cystectomy'}], 'ancestors': [{'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '7 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2038-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-19', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-19', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who will die from bladder cancer', 'timeFrame': 'From enrollment to late follow-up, up to 7 years', 'description': 'Bladder Cancer Specific Mortality after surgery'}, {'measure': 'Number of participants who will experience bladder cancer recurrence', 'timeFrame': 'From enrollment to late follow-up, up to 7 years', 'description': 'Bladder Cancer Recurrence'}, {'measure': 'Number of participants who will die from all causes', 'timeFrame': 'From enrollment to late follow-up, up to 7 years', 'description': 'All cause mortality after surgery'}], 'secondaryOutcomes': [{'measure': 'Number of participants who will die from bladder cancer after Robotic Surgery', 'timeFrame': 'From enrollment to late follow-up, up to 7 years', 'description': 'Robotic surgery specific impact on survival'}, {'measure': 'Number of participants who will experience bladder cancer recurrence after Robotic Surgery', 'timeFrame': 'From enrollment to late follow-up, up to 7 years', 'description': 'Robotic surgery specific impact on recurrence'}, {'measure': 'Number of participants who will experience surgical complications after Robotic Surgery', 'timeFrame': 'From enrollment to late follow-up, up to 7 years', 'description': 'Robotic surgery specific impact on surgical complications'}, {'measure': 'Variation in Quality of Life questionnaire after Robotic Surgery', 'timeFrame': 'From enrollment to late follow-up, up to 7 years', 'description': 'Robotic surgery specific impact on quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)'}, {'measure': 'Variation in Quality of Life questionnaire according to Urinary diversions', 'timeFrame': 'From enrollment to late follow-up, up to 7 years', 'description': 'Urinary diversion specific impact on quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)'}, {'measure': 'Number of participants who will experience surgical complications according to Urinary diversions', 'timeFrame': 'From enrollment to late follow-up, up to 7 years', 'description': 'Urinary diversion specific impact on surgical complications'}, {'measure': 'Number of participants who will experience bladder cancer recurrence according to Urinary diversions', 'timeFrame': 'From enrollment to late follow-up, up to 7 years', 'description': 'Urinary diversion specific impact on bladder cancer recurrence'}, {'measure': 'Number of participants who will die from bladder cancer according to Urinary diversions', 'timeFrame': 'From enrollment to late follow-up, up to 7 years', 'description': 'Urinary diversion specific impact on bladder cancer rmortality'}, {'measure': 'Number of participants who will die from all causes according to Urinary diversions', 'timeFrame': 'From enrollment to late follow-up, up to 7 years', 'description': 'Urinary diversion specific impact on all cause mortality after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystectomy', 'Radical Cystectomy', 'Ileal Conduit', 'Neobladder', 'Bladder Cancer', 'Muscle Invasive Bladder Cancer'], 'conditions': ['Bladder Cancer', 'Muscle-Invasive Bladder Carcinoma', 'Oncology', 'Recurrence', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Currently, in the treatment of bladder cancer the use of robotics has entered in clinical practice, therefor robotic radical cystectomy with or without reconstruction is offered to patients during counseling procedures, if deemed appropriate and possible. The aim of the study is therefore the long-term evaluation of the peri-post-operative, oncological and functional results of patients undergoing radical cystectomy, both with an open and robotic approach. This study will thus help to clarify the actual impact of robotic surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is made up of patients who underwent radical cystectomy at AOU Careggi, SOD Robotic Urological Surgery, Minimally Invasive and Renal Transplantation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age major or equal 18 years\n* Patients who will undergo radical cystectomy\n* Consent to participate\n\nExclusion Criteria:\n\n* Absence of willingness to participate\n* Further refusal to participate to the study'}, 'identificationModule': {'nctId': 'NCT04900558', 'briefTitle': 'Robotic Radical Cystectomy Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Florence'}, 'officialTitle': 'Impact of Robotic Surgery on Post-operative Outcomes of Patients Who Underwent Radical Cystectomy', 'orgStudyIdInfo': {'id': '19303_oss'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radical Cystectomy', 'description': 'Patients who underwent radical cystectomy for bladder cancer in our centre', 'interventionNames': ['Procedure: Radical Cystectomy']}], 'interventions': [{'name': 'Radical Cystectomy', 'type': 'PROCEDURE', 'description': 'All the patients enrolled have undergone or will undergo radical cystectomy, with or without lymphadenectomy or urethrectomy All possibles urinary diversion are included, like ileal conduit, neobladder etc...', 'armGroupLabels': ['Radical Cystectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50134', 'city': 'Florence', 'state': 'Tuscany', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simone Morselli, MD', 'role': 'CONTACT', 'email': 'simone.morselli@unifi.it', 'phone': '3473050852'}, {'name': 'Arcangelo Sebastianelli, MD', 'role': 'CONTACT', 'email': 'arcangelo.sebastianelli@gmail.com'}, {'name': 'Sergio Serni, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mauro Gacci, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Simone Morselli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maria Rosaria Raspollini, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Arcangelo Sebastianelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Riccardo Campi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Donata Villari, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Graziano Vignolini, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Saverio Giancane, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pietro Spatafora, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrea Liaci, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Luca Gemma, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Careggi University Hospital', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'centralContacts': [{'name': 'Simone Morselli, MD', 'role': 'CONTACT', 'email': 'simone.morselli.89@gmail.com', 'phone': '3473050852'}, {'name': 'Silvia Benemei, PhD', 'role': 'CONTACT', 'email': 'silvia.benemei@unifi.it'}], 'overallOfficials': [{'name': 'Arcangelo Sebastianelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Careggi Hospital, University of Florence'}, {'name': 'Sergio Serni, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florence'}, {'name': 'Simone Morselli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florence'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florence', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Simone Morselli', 'investigatorAffiliation': 'University of Florence'}}}}