Infectious Complications After Cystectomy: A Prospective Observational Study

November 29, 2021 updated by: Benedikt Ebner, Ludwig-Maximilians - University of Munich
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Outside U.S./Canada
      • Munich, Outside U.S./Canada, Germany, 81377
        • Recruiting
        • Urology Department - LMU Klinikum
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who undergo cystectomy

Description

Inclusion Criteria:

  • Disease which requires removal of the urinary bladder

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infectious Complications
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

November 30, 2024

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)

December 10, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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