Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusions.

August 25, 2025 updated by: Armin N. Flinspach, Goethe University

Prospective Evaluation of Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusion Requirements.

What influence does robot-assisted surgical treatment in the sense of a radical cystectomy and possibly bladder reconstruction have on blood loss, pain and transfusion requirements? We intend to conduct a corresponding prospective observational study at a tertiary centre.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a mostly oncological indication for radical cystectomy

Description

Inclusion Criteria:

  • planned radical cystectomy

Exclusion Criteria:

  • ASA classification V
  • Previously known coagulation disorder

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

Cohorts and Interventions

Group / Cohort
Robot assistet
Robot assistet laparoscopic cystectomy
Conventional
Conventional laparotomy for cystektomie

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perioperative blood loss
Time Frame: 6 hours
perioperative blood loss
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative iron deficiency
Time Frame: up to 4 weeks prior surgery
Preoperative messured iron deficiency
up to 4 weeks prior surgery
RBC transfusion
Time Frame: perioperative up to hospital discharge or death (up to 4 weeks)
Number of RBC transfusions
perioperative up to hospital discharge or death (up to 4 weeks)

Collaborators and Investigators

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

Sponsor

Goethe University

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 (Actual)

August 1, 2025

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 27, 2025

First Submitted That Met QC Criteria

June 4, 2025

First Posted (Actual)

June 6, 2025

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBM in robot cystectomies

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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