Robot-assisted Cystectomies With Regard to Blood Loss, Pa... | NCT07008261

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

NCT07008261

Sponsor

Goethe University

Status

Recruiting

Last Update Posted

Sep 2, 2025Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Transfusions
Cystectomy
Blood Loss Requiring Transfusion
Anaemia
Anaemia Postoperative
Pain, Postoperative

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Actual

Primary Completion Date

May 30, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

May 27, 2025

First Submission Date that Met QC Criteria

Jun 4, 2025

First Posted Date

Jun 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2025

Last Update Posted Date

Sep 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robot assistet		Robot assistet laparoscopic cystectomy
Conventional		Conventional laparotomy for cystektomie

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Preoperative iron deficiency	Preoperative messured iron deficiency	up to 4 weeks prior surgery
RBC transfusion	Number of RBC transfusions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

planned radical cystectomy

Exclusion Criteria:

ASA classification V
Previously known coagulation disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a mostly oncological indication for radical cystectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Armin Flinspach N PD. Dr. med. habil., M.D.	Contact	+49 69 6301 84136		armin.flinspach@unimedizin-ffm.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uniklinikum	Recruiting	Frankfurt am Main		60598	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided