Actively Recruiting

Age: 18Years +
All Genders
ID07008261

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

Led by Goethe University · Updated on 2025-09-02

60

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective observational study to understand how robot-assisted surgical treatment for radical cystectomy and possible bladder reconstruction affects blood loss, pain, and the need for blood transfusions. This study takes place at a tertiary center and aims to compare robot-assisted laparoscopic cystectomy with conventional laparotomy. It focuses on patients who are planned for radical cystectomy and evaluates important surgical outcomes. Participants will undergo one of two surgical approaches: robot-assisted laparoscopic cystectomy or conventional open surgery through laparotomy. The study will measure blood loss during the perioperative period, specifically within six hours of surgery. It will also assess preoperative iron deficiency up to four weeks before surgery and monitor red blood cell transfusions from the perioperative period up to hospital discharge or death, which may occur up to four weeks after surgery. During the study, participants will be closely observed for blood loss, pain levels, and transfusion requirements. Researchers will collect data on surgical outcomes and patient conditions before and after surgery. The study starts in August 2025 and will continue through December 2027. Participants will be monitored throughout their hospital stay and up to four weeks after surgery to gather comprehensive information on these key measures.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Planned radical cystectomy
Not Eligible

You will not qualify if you...

  • ASA classification V (severe systemic disease with constant threat to life)
  • Previously known coagulation disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 4 weeks prior to surgery

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Perioperative period up to hospital discharge or death (up to 4 weeks)

Participants undergo robot-assisted or conventional laparoscopic cystectomy and are monitored for blood loss, pain, and transfusion requirements during and immediately after surgery.

1 hospital stay including surgery and monitoring

Trial Site Locations

Total: 1 location

1

Uniklinikum

Frankfurt am Main, Germany, 60598

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Research Team

A

Armin Flinspach N PD. Dr. med. habil., M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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