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.

Study Overview

• Status: Recruiting
• Conditions: Infections; Urinary Bladder Diseases; Urinary Tract Infections; Bladder Cancer; Infection, Bacterial; Urinary Tract Disease; Infection, Hospital; Infection Wound
• Intervention / Treatment: Procedure: Cystectomy

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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Benedikt Ebner, Dr.; Phone Number: 004917655197898; Email: Benedikt.Ebner@med.uni-muenchen.de

Study Locations

• Germany
  • Outside U.S./Canada
    • Munich, Outside U.S./Canada, Germany, 81377
      • Recruiting
      • Urology Department - LMU Klinikum
      • Contact: Benedikt Ebner; Phone Number: 017655197898; Email: Benedikt.Ebner@gmx.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo cystectomy

Description

Inclusion Criteria:

• Disease which requires removal of the urinary bladder

Exclusion Criteria:

• Patient does not want to participate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infectious parameters on the first postoperative day after cystectomy	IL-6 level, procalcitonin level and wound drainage culture	First postoperative day
Postoperative fever	Proportion of cystectomy patients that develops fever postoperatively (≥38.0°C)	Surgery - discharge
Antibiotic use	Proportion of cystectomy patients that need additional oral or i.v. antibiotic therapy (on top of the hospital standard)	Surgery - discharge
In-hospital complications	Clavien-Dindo Classification and Comprehensive Complication Index	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	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	0-12 months after discharge
Emergency consultation	Proportion of cystectomy patients with a cystectomy-associated emergency consultation in the first year after discharge	0-12 months after discharge
Inpatient admission	Proportion of cystectomy patients with a cystectomy-associated inpatient admission in the first year after discharge	0-12 months after discharge
Preoperative interleukin-6 level	IL-6 level before surgery	1 day before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IMCU/ICU nights	Number of nights spent at a IMCU/ICU postoperatively	Surgery - discharge
Duration of hospital stay	Total hospital stay (nights)	Surgery - discharge
Subjective grading of in-hospital complications	Subjective assessment: no complications, minor complications or major complications	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	Assessed 3 months after discharge
Health related quality of life	EORTC QLQ-C30, FACT-BL- and QLQ-BLM30-questionnaires after 3 months	Assessed 3 months after discharge

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Gerald Schulz, PD Dr., Ludwig-Maximilians - University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Iatrogenic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Urinary Tract Infections; Bacterial Infections; Urologic Diseases; Urinary Bladder Diseases; Cross Infection
• Other Study ID Numbers: RCXINFLMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No