Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05153694
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2021-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infectious Complications After Cystectomy: A Prospective Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-13', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infectious parameters on the first postoperative day after cystectomy', 'timeFrame': 'First postoperative day', 'description': 'IL-6 level, procalcitonin level and wound drainage culture'}, {'measure': 'Postoperative fever', 'timeFrame': 'Surgery - discharge', 'description': 'Proportion of cystectomy patients that develops fever postoperatively (≥38.0°C)'}, {'measure': 'Antibiotic use', 'timeFrame': 'Surgery - discharge', 'description': 'Proportion of cystectomy patients that need additional oral or i.v. antibiotic therapy (on top of the hospital standard)'}, {'measure': 'In-hospital complications', 'timeFrame': 'Surgery - discharge', 'description': 'Clavien-Dindo Classification and Comprehensive Complication Index'}, {'measure': 'Antibiotic therapy within the first year after discharge', 'timeFrame': '0-12 months after discharge', 'description': 'Proportion of cystectomy patients that needs antibiotic therapy associated with urinary diversion in the first year after discharge'}, {'measure': 'Fever within the first year after discharge', 'timeFrame': '0-12 months after discharge', 'description': 'Proportion of cystectomy patients with urinary tract associated fever in the first year after discharge'}, {'measure': 'Emergency consultation', 'timeFrame': '0-12 months after discharge', 'description': 'Proportion of cystectomy patients with a cystectomy-associated emergency consultation in the first year after discharge'}, {'measure': 'Inpatient admission', 'timeFrame': '0-12 months after discharge', 'description': 'Proportion of cystectomy patients with a cystectomy-associated inpatient admission in the first year after discharge'}, {'measure': 'Preoperative interleukin-6 level', 'timeFrame': '1 day before surgery', 'description': 'IL-6 level before surgery'}], 'secondaryOutcomes': [{'measure': 'IMCU/ICU nights', 'timeFrame': 'Surgery - discharge', 'description': 'Number of nights spent at a IMCU/ICU postoperatively'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'Surgery - discharge', 'description': 'Total hospital stay (nights)'}, {'measure': 'Subjective grading of in-hospital complications', 'timeFrame': 'Assessed time: Surgery - discharge. Assessed 3 months after discharge', 'description': 'Subjective assessment: no complications, minor complications or major complications'}, {'measure': 'Rating of the pre-operatively provided medical information', 'timeFrame': 'Assessed 3 months after discharge', 'description': 'Subjective assessment: very good, good, satisfactory, sufficient, not sufficient'}, {'measure': 'Health related quality of life', 'timeFrame': 'Assessed 3 months after discharge', 'description': 'EORTC QLQ-C30, FACT-BL- and QLQ-BLM30-questionnaires after 3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer', 'Infections', 'Infection, Bacterial', 'Infection, Hospital', 'Infection Wound', 'Urinary Tract Infections', 'Urinary Bladder Diseases', 'Urinary Tract Disease']}, 'referencesModule': {'references': [{'pmid': '41334533', 'type': 'DERIVED', 'citation': 'Ebner B, Hirsch J, Holz A, Eismann L, Hermans J, Pyrgidis N, Kidess M, Semmler M, Brinkmann I, Aydogdu C, Chaloupka M, Apfelbeck M, Lindner AK, Weinhold P, Stief CG, Volz Y, Schulz GB. Prospective Evaluation of Blood-based and Microbiological Early Indicators of In-hospital Infectious Complications After Open Cystectomy. Eur Urol Open Sci. 2025 Nov 18;83:1-8. doi: 10.1016/j.euros.2025.10.019. eCollection 2026 Jan.'}, {'pmid': '41006129', 'type': 'DERIVED', 'citation': 'Ebner B, Hirsch J, Holz A, Volz Y, Eismann L, Hermans J, Pyrgidis N, Kidess M, Semmler M, Fouladgar ST, Papadopoulos I, Chaloupka M, Apfelbeck M, Marcon J, Weinhold P, Ewert A, Kazmierczak P, Stief CG, Schulz GB. Association of interleukin-6 serum levels with local tumor stage and lymph node metastasis of urothelial carcinoma. Urol Oncol. 2025 Dec;43(12):693.e1-693.e8. doi: 10.1016/j.urolonc.2025.08.026. Epub 2025 Sep 25.'}, {'pmid': '39928165', 'type': 'DERIVED', 'citation': 'Ebner B, Hirsch J, Holz A, Volz Y, Eismann L, Hermans J, Pyrgidis N, Kidess M, Semmler M, Brinkmann I, Aydogdu C, Chaloupka M, Lindner AK, Weinhold P, Stief CG, Schulz GB. Discrepancies between physician-assessed and patient-reported complications after cystectomy - a prospective analysis. World J Urol. 2025 Feb 10;43(1):115. doi: 10.1007/s00345-025-05487-7.'}]}, 'descriptionModule': {'briefSummary': "Patients undergoing cystectomy for either oncological or non-oncological indications are prospectively enrolled following informed consent. This study design incorporates a comprehensive medical history, detailed prospective documentation of clinicopathological parameters, and serial measurements of infectious markers pre- and post-operatively. In-hospital complications are meticulously recorded, and long-term outcomes assessed through structured follow-up interviews at 3, 6, and 12 months. These follow-ups utilize standardized questionnaires to evaluate post-discharge infectious complications and gather patients' perspectives on their in-hospital experiences, providing a robust understanding of both clinical outcomes and patient-reported experiences.", 'detailedDescription': 'Aims of the study:\n\n1. Prospective evaluation of the association between preoperative interleukin-6 levels and local tumor stage in patients undergoing radical cystectomy\n2. Prospective assessment of interleukin-6, procalcitonin and wound drainage culture as early indicators for perioperative infectious complications after cystectomy\n3. Prospective evaluation of physician-assessed vs. patient-reported grading of complications after cystectomy\n4. Prospective comparison of infectious complications within the first 12 months after cystectomy: ileal neobladder vs. ileal conduit\n5. Prospective evaluation of the association between in-hospital complications after cystectomy and quality of life after three months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who undergo cystectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Disease which requires removal of the urinary bladder\n\nExclusion Criteria:\n\n* Patient does not want to participate'}, 'identificationModule': {'nctId': 'NCT05153694', 'briefTitle': 'Infectious Complications After Cystectomy: A Prospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Infectious Complications After Cystectomy: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'RCXINFLMU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cystectomy', 'type': 'PROCEDURE', 'description': 'Removal of the urinary bladder'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'state': 'Outside U.S./Canada', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Benedikt Ebner', 'role': 'CONTACT', 'email': 'Benedikt.Ebner@gmx.at', 'phone': '017655197898'}], 'facility': 'Urology Department - LMU Klinikum', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Benedikt Ebner, Dr.', 'role': 'CONTACT', 'email': 'Benedikt.Ebner@med.uni-muenchen.de', 'phone': '004917655197898'}], 'overallOfficials': [{'name': 'Gerald Schulz, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ludwig-Maximilians - University of Munich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident in Urology', 'investigatorFullName': 'Benedikt Ebner', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}