Infectious Complications After Cystectomy: A Prospective Observational Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLudwig-Maximilians - University of Munich

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Disease which requires removal of the urinary bladder

Disqualifiers

Patient does not want to participate

Trial population

Patients who undergo cystectomy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cystectomy

    Procedure/Surgery

    Removal of the urinary bladder

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Infectious parameters on the first postoperative day after cystectomy

IL-6 level, procalcitonin level and wound drainage culture

Time frame
First postoperative day
2

Postoperative fever

Proportion of cystectomy patients that develops fever postoperatively (≥38.0°C)

Time frame
Surgery - discharge
3

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
4

In-hospital complications

Clavien-Dindo Classification and Comprehensive Complication Index

Time frame
Surgery - discharge

Secondary outcomes

1

IMCU/ICU nights

Number of nights spent at a IMCU/ICU postoperatively

Time frame
Surgery - discharge
2

Duration of hospital stay

Total hospital stay (nights)

Time frame
Surgery - discharge
3

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
4

Rating of the pre-operatively provided medical information

Subjective assessment: very good, good, satisfactory, sufficient, not sufficient

Time frame
Assessed 3 months after discharge

Other outcomes

Sponsors and contacts

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