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.
Aims of the study: 1. Prospective evaluation of the association between preoperative interleukin-6 levels and local tumor stage in patients undergoing radical cystectomy 2. Prospective assessment of interleukin-6, procalcitonin and wound drainage culture as early indicators for perioperative infectious complications after cystectomy 3. Prospective evaluation of physician-assessed vs. patient-reported grading of complications after cystectomy 4. Prospective comparison of infectious complications within the first 12 months after cystectomy: ileal neobladder vs. ileal conduit 5. Prospective evaluation of the association between in-hospital complications after cystectomy and quality of life after three months
Study Type
OBSERVATIONAL
Enrollment
200
Removal of the urinary bladder
Urology Department - LMU Klinikum
Munich, Outside U.S./Canada, Germany
RECRUITINGInfectious parameters on the first postoperative day after cystectomy
IL-6 level, procalcitonin level and wound drainage culture
Time frame: First postoperative day
Postoperative fever
Proportion of cystectomy patients that develops fever postoperatively (≥38.0°C)
Time frame: Surgery - discharge
Antibiotic use
Proportion of cystectomy patients that need additional oral or i.v. antibiotic therapy (on top of the hospital standard)
Time frame: Surgery - discharge
In-hospital complications
Clavien-Dindo Classification and Comprehensive Complication Index
Time frame: Surgery - discharge
Antibiotic therapy within the first year after discharge
Proportion of cystectomy patients that needs antibiotic therapy associated with urinary diversion in the first year after discharge
Time frame: 0-12 months after discharge
Fever within the first year after discharge
Proportion of cystectomy patients with urinary tract associated fever in the first year after discharge
Time frame: 0-12 months after discharge
Emergency consultation
Proportion of cystectomy patients with a cystectomy-associated emergency consultation in the first year after discharge
Time frame: 0-12 months after discharge
Inpatient admission
Proportion of cystectomy patients with a cystectomy-associated inpatient admission in the first year after discharge
Time frame: 0-12 months after discharge
Preoperative interleukin-6 level
IL-6 level before surgery
Time frame: 1 day before surgery
IMCU/ICU nights
Number of nights spent at a IMCU/ICU postoperatively
Time frame: Surgery - discharge
Duration of hospital stay
Total hospital stay (nights)
Time frame: Surgery - discharge
Subjective grading of in-hospital complications
Subjective assessment: no complications, minor complications or major complications
Time frame: Assessed time: Surgery - discharge. Assessed 3 months after discharge
Rating of the pre-operatively provided medical information
Subjective assessment: very good, good, satisfactory, sufficient, not sufficient
Time frame: Assessed 3 months after discharge
Health related quality of life
EORTC QLQ-C30, FACT-BL- and QLQ-BLM30-questionnaires after 3 months
Time frame: Assessed 3 months after discharge
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