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NCT Number: NCT05153694

Infectious Complications After Cystectomy: A Prospective Observational Study

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.

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Key information

Conditions

Bladder Cancer Bacterial Infections Bacterial Infections and Mycoses Cross Infection Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Iatrogenic Disease Infection Wound Infection, Bacterial Infection, Hospital Infections Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Bladder Diseases Urinary Bladder Neoplasms Urinary Tract Disease Urinary Tract Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Wound Infection

Sex eligibility

All sexes

Study type

Observational

Primary location

Urology Department - LMU Klinikum

Munich, Outside U.S./Canada, 81377, Germany

Location status: Recruiting

Location contact

Benedikt Ebner

CONTACT

[email protected]

017655197898

About this study

Aims of the study:

  • Prospective evaluation of the association between preoperative interleukin-6 levels and local tumor stage in patients undergoing radical cystectomy
  • Prospective assessment of interleukin-6, procalcitonin and wound drainage culture as early indicators for perioperative infectious complications after cystectomy
  • Prospective evaluation of physician-assessed vs. patient-reported grading of complications after cystectomy
  • Prospective comparison of infectious complications within the first 12 months after cystectomy: ileal neobladder vs. ileal conduit
  • Prospective evaluation of the association between in-hospital complications after cystectomy and quality of life after three months

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Disease which requires removal of the urinary bladder

Exclusion criteria

  • Patient does not want to participate

Treatment and study plan

Cystectomy

Procedure

Removal of the urinary bladder

Primary outcomes

  1. Infectious parameters on the first postoperative day after cystectomy

    Time frame: First postoperative day

    IL-6 level, procalcitonin level and wound drainage culture

  2. Postoperative fever

    Time frame: Surgery - discharge

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

  3. Antibiotic use

    Time frame: Surgery - discharge

    Proportion of cystectomy patients that need additional oral or i.v. antibiotic therapy (on top of the hospital standard)

  4. In-hospital complications

    Time frame: Surgery - discharge

    Clavien-Dindo Classification and Comprehensive Complication Index

  5. Antibiotic therapy within the first year after discharge

    Time frame: 0-12 months after discharge

    Proportion of cystectomy patients that needs antibiotic therapy associated with urinary diversion in the first year after discharge

  6. Fever within the first year after discharge

    Time frame: 0-12 months after discharge

    Proportion of cystectomy patients with urinary tract associated fever in the first year after discharge

  7. Emergency consultation

    Time frame: 0-12 months after discharge

    Proportion of cystectomy patients with a cystectomy-associated emergency consultation in the first year after discharge

  8. Inpatient admission

    Time frame: 0-12 months after discharge

    Proportion of cystectomy patients with a cystectomy-associated inpatient admission in the first year after discharge

  9. Preoperative interleukin-6 level

    Time frame: 1 day before surgery

    IL-6 level before surgery

Secondary outcomes

  1. IMCU/ICU nights

    Time frame: Surgery - discharge

    Number of nights spent at a IMCU/ICU postoperatively

  2. Duration of hospital stay

    Time frame: Surgery - discharge

    Total hospital stay (nights)

  3. Subjective grading of in-hospital complications

    Time frame: Assessed time: Surgery - discharge. Assessed 3 months after discharge

    Subjective assessment: no complications, minor complications or major complications

  4. Rating of the pre-operatively provided medical information

    Time frame: Assessed 3 months after discharge

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

  5. Health related quality of life

    Time frame: Assessed 3 months after discharge

    EORTC QLQ-C30, FACT-BL- and QLQ-BLM30-questionnaires after 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Benedikt Ebner, Dr.

CONTACT

[email protected]

004917655197898

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Dec 10, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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