Clinical trial NCT05153694: Infectious Complications After Cystectomy: A Prospective Observational Study
Official title: Infectious Complications After Cystectomy: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Infections
Infection, Bacterial
Infection, Hospital
Infection Wound
Urinary Tract Infections
Urinary Bladder Diseases
Urinary Tract Disease
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo cystectomy

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Disease which requires removal of the urinary bladder

Exclusion Criteria:

* Patient does not want to participate

Primary outcomes:
measure: Infectious parameters on the first postoperative day after cystectomy
timeFrame: First postoperative day
measure: Postoperative fever
timeFrame: Surgery - discharge
measure: Antibiotic use
timeFrame: Surgery - discharge
measure: In-hospital complications
timeFrame: Surgery - discharge
measure: Antibiotic therapy within the first year after discharge
timeFrame: 0-12 months after discharge
measure: Fever within the first year after discharge
timeFrame: 0-12 months after discharge
measure: Emergency consultation
timeFrame: 0-12 months after discharge
measure: Inpatient admission
timeFrame: 0-12 months after discharge
measure: Preoperative interleukin-6 level
timeFrame: 1 day before surgery
Secondary outcomes:
measure: IMCU/ICU nights
timeFrame: Surgery - discharge
measure: Duration of hospital stay
timeFrame: Surgery - discharge
measure: Subjective grading of in-hospital complications
timeFrame: Assessed time: Surgery - discharge. Assessed 3 months after discharge
measure: Rating of the pre-operatively provided medical information
timeFrame: Assessed 3 months after discharge
measure: Health related quality of life
timeFrame: Assessed 3 months after discharge
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Urology Department - LMU Klinikum
state: Outside U.S./Canada
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Gerald Schulz, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: