Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
Study NCT ID:
NCT07008261
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2025-05-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'perioperative blood loss', 'timeFrame': '6 hours', 'description': 'perioperative blood loss'}], 'secondaryOutcomes': [{'measure': 'Preoperative iron deficiency', 'timeFrame': 'up to 4 weeks prior surgery', 'description': 'Preoperative messured iron deficiency'}, {'measure': 'RBC transfusion', 'timeFrame': 'perioperative up to hospital discharge or death (up to 4 weeks)', 'description': 'Number of RBC transfusions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transfusions', 'Cystectomy', 'Blood Loss Requiring Transfusion', 'Anaemia', 'Anaemia Postoperative', 'Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'What influence does robot-assisted surgical treatment in the sense of a radical cystectomy and possibly bladder reconstruction have on blood loss, pain and transfusion requirements? We intend to conduct a corresponding prospective observational study at a tertiary centre.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a mostly oncological indication for radical cystectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* planned radical cystectomy\n\nExclusion Criteria:\n\n* ASA classification V\n* Previously known coagulation disorder'}, 'identificationModule': {'nctId': 'NCT07008261', 'briefTitle': 'Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusions.', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Prospective Evaluation of Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusion Requirements.', 'orgStudyIdInfo': {'id': 'PBM in robot cystectomies'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Robot assistet', 'description': 'Robot assistet laparoscopic cystectomy'}, {'label': 'Conventional', 'description': 'Conventional laparotomy for cystektomie'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60598', 'city': 'Frankfurt am Main', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'PI, MD', 'role': 'CONTACT', 'email': 'Flinspach@mned.uni-frankfurt.de', 'phone': '+4963015868'}], 'facility': 'Uniklinikum', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'centralContacts': [{'name': 'Armin Flinspach N PD. Dr. med. habil., M.D.', 'role': 'CONTACT', 'email': 'armin.flinspach@unimedizin-ffm.de', 'phone': '+49 69 6301 84136'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior physician', 'investigatorFullName': 'Armin N. Flinspach', 'investigatorAffiliation': 'Goethe University'}}}}