Infectious Complications After Cystectomy: A Prospective Observational Study

Recruiting

• Conditions: Infection, Hospital; Infections; Urinary Tract Infections; Infection, Bacterial; Infection Wound; Urinary Bladder Diseases; Urinary Tract Disease; Bladder Cancer

• Registration Number: NCT05153694
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

In this study, we evaluate peri- and postoperative parameters of patients undergoing a cystectomy and try to find risk factors for infectious complications. In detail, we analyze their medical history, demographic data, lab values, microbiological tests as well as histological and radiological findings. Furthermore, after discharging our patients, we send them several follow-up questionnaires at regular intervals and offer them free follow-up examinations.

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 Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Last Update Submitted: 2021-11-29
• Study Start: 2021-12-01
• Study First Posted: 2021-12-10
• Last Update Posted: 2021-12-10
• Primary Completion: 2023-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Disease which requires removal of the urinary bladder

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
IMCU/ICU nights	Surgery - discharge	Number of nights spent at a IMCU/ICU postoperatively
Duration of hospital stay	Surgery - discharge	Total hospital stay (nights)
Subjective grading of in-hospital complications	Assessed time: Surgery - discharge. Assessed 3 months after discharge	Subjective assessment: no complications, minor complications or major complications
Rating of the pre-operatively provided medical information	Assessed 3 months after discharge	Subjective assessment: very good, good, satisfactory, sufficient, not sufficient
Health related quality of life	Assessed 3 months after discharge	EORTC QLQ-C30, FACT-BL- and QLQ-BLM30-questionnaires after 3 months

Trial Locations

Locations (1)

Urology Department - LMU Klinikum; 🇩🇪 Munich, Outside U.S./Canada, Germany