Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT03280459
Status:
UNKNOWN
Last Update Posted:
2017-09-12
First Post:
2017-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-11', 'studyFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2017-09-11', 'lastUpdatePostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative complications', 'timeFrame': '1 year', 'description': 'deviations from normal postoperative course \\["Clavien-Dindo" Grade\\]'}], 'secondaryOutcomes': [{'measure': 'Treatment of tumor recurrence', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Treatment of tumor recurrence (radiotherapy, chemotherapy, operation)'}, {'measure': 'Quality of Life urology specific', 'timeFrame': '1 year', 'description': 'EORTC-BLM 30 (European Organisation for Research and Treatment of Cancer Questionaire for muscle invasive bladder cancer) questionaire for evaluation of quality of life for patients with muscle invasive bladder cancer'}, {'measure': 'Quality of Life overall', 'timeFrame': '1 year', 'description': 'EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire) questionaire for evaluation of quality of life for oncologic patients'}, {'measure': 'Operation Time', 'timeFrame': 'expected 4-8 hours', 'description': 'duration of operation \\[min\\]'}, {'measure': 'Postoperative Death by any cause', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Death by any cause \\[n/months\\]'}, {'measure': 'Pouch capacity', 'timeFrame': '1 year', 'description': 'interventional measurement of pouch capacity with pressure recording catheter \\[ml\\]'}, {'measure': 'Type of tumor-recurrence', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Location of tumor recurrence (local, metastasis)'}, {'measure': 'Blood loss', 'timeFrame': 'expected 4-8 hours', 'description': 'blood loss during operation \\[ml\\]'}, {'measure': 'Time to recurrence', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'time until recurrence of tumor \\[months\\]'}, {'measure': 'Tumor specific death', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Time to tumor specific death \\[months\\]'}, {'measure': 'Preoperative Tumor staging', 'timeFrame': '90 days', 'description': 'Preoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)'}, {'measure': 'Postoperative Tumor staging', 'timeFrame': '90 days', 'description': 'Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)'}, {'measure': 'Pouch-pressure', 'timeFrame': '1 year', 'description': 'interventional measurement of pouch-pressure \\[cmH2O\\]with pressure recording catheter'}, {'measure': 'Postvoid residual urine', 'timeFrame': '1 year', 'description': 'Residual urin after voiding \\[ml\\]'}, {'measure': 'Functional length of urethral sphincter', 'timeFrame': '1 year', 'description': 'interventional measurement of Functional length of urethral sphincter \\[mm\\] with pressure recording catheter'}, {'measure': 'Functional pressure of urethral sphincter', 'timeFrame': '1 year', 'description': 'interventional measurement of functional pressure of urethral sphincter \\[cmH2O\\] with pressure recording catheter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urothelial Carcinoma', 'Cystectomy', 'Urinary Diversion', 'Complication of Surgical Procedure', 'Complication, Postoperative', 'Neobladder', 'Ileal Conduit', 'Robotic Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'Continous evaluation of clinical and oncologic outcome of robot-assisted cystectomy with intracorporeal reconstruction of urinary diversion. Patient Data is entered in an anonymized registry for analyzation.', 'detailedDescription': 'The registry includes patients after robot-assisted cystectomy, mainly as therapy for muscle invasive urothelial carcinoma. The urinary diversion will be completed intracorporeal either as ileal conduit or ileal neobladder. Outcome parameters include perioperative complications, oncologic data and oncologic follow-up data (tumor classification, recurrence, survival) as well as data on functional follow up (continence, quality of life).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Onkologic patients that qualify for radical cystectomy according to institutional tumor-board decision or patients with functional indications after failure of all other therapy modalities and receive a cystectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years\n* informed consent for operation and data use\n* Oncologic patients that qualify for radical cystectomy according to institutional tumor-board decision or patients with functional indications after failure of all other therapy modalities and receive a cystectomy\n\nExclusion Criteria:\n\n* age \\<18 years\n* declined informed consent / data use\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03280459', 'acronym': 'iRARC-KSW', 'briefTitle': 'Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Winterthur KSW'}, 'officialTitle': 'Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion', 'orgStudyIdInfo': {'id': '2017-01260'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ileal Conduit', 'description': 'Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy', 'interventionNames': ['Procedure: robot-assisted cystectomy']}, {'label': 'Neobladder', 'description': 'Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy', 'interventionNames': ['Procedure: robot-assisted cystectomy']}], 'interventions': [{'name': 'robot-assisted cystectomy', 'type': 'PROCEDURE', 'description': 'Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy', 'armGroupLabels': ['Ileal Conduit', 'Neobladder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8401', 'city': 'Winterthur', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Christoph Schregel, M.D.', 'role': 'CONTACT', 'email': 'christophschregel@gmx.de', 'phone': '+4152264331', 'phoneExt': '+14766737873'}, {'name': 'Hubert John, M.D.', 'role': 'CONTACT', 'email': 'hubert.john@ksw.ch', 'phone': '+41522662982'}], 'facility': 'Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}], 'centralContacts': [{'name': 'Christoph Schregel, MD', 'role': 'CONTACT', 'email': 'christophschregel@gmx.de'}, {'name': 'Orlando Burkhardt, MD', 'role': 'CONTACT', 'phone': '+41792912821'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'depersonalized Data may be shared with other academic centers if data security and ethical considerations equal to swiss standards are followed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Winterthur KSW', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistenzarzt Urologie / resident Departement of Urology', 'investigatorFullName': 'Christoph Schregel', 'investigatorAffiliation': 'Kantonsspital Winterthur KSW'}}}}