NCT07008261

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Aug 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Aug 2025Dec 2027

First Submitted

Initial submission to the registry

May 27, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 2, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

May 27, 2025

Last Update Submit

August 25, 2025

Conditions

TransfusionsCystectomyBlood Loss Requiring TransfusionAnaemiaAnaemia PostoperativePain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • perioperative blood loss

    perioperative blood loss

    6 hours

Secondary Outcomes (2)

  • Preoperative iron deficiency

    up to 4 weeks prior surgery

  • RBC transfusion

    perioperative up to hospital discharge or death (up to 4 weeks)

Study Arms (2)

Robot assistet

Robot assistet laparoscopic cystectomy

Conventional

Conventional laparotomy for cystektomie

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a mostly oncological indication for radical cystectomy

You may qualify if:

  • planned radical cystectomy

You may not qualify if:

  • ASA classification V
  • Previously known coagulation disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniklinikum

Frankfurt am Main, 60598, Germany

RECRUITING

MeSH Terms

Conditions

AnemiaPain, Postoperative

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

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

CONTACT

+49 69 6301 84136armin.flinspach@unimedizin-ffm.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior physician

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 6, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 2, 2025

Record last verified: 2025-06

Locations

DE(1)