TransfusionsNCT07008261
Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusions.
An observational study of Transfusions and Cystectomy, run by Goethe University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfusions, Cystectomy, Blood Loss Requiring Transfusion
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a mostly oncological indication for radical cystectomy
Who may be able to join
- planned radical cystectomy
Who cannot join
- ASA classification V
- Previously known coagulation disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Armin Flinspach N PD. Dr. med. habil., M.D. contact
Germany1 site, 1 recruiting
- Recruiting
Uniklinikum
Frankfurt am Main, 60598
PI, MD, +4963015868, Flinspach@mned.uni-frankfurt.de
About this study
Official title: 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.
- Conditions
- Transfusions, Cystectomy, Blood Loss Requiring Transfusion, Anaemia, Anaemia Postoperative, Pain, Postoperative
- Medical subject headings
- Anemia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Robot assistet | Robot assistet laparoscopic cystectomy | |
| Conventional | Conventional laparotomy for cystektomie |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative blood loss
perioperative blood loss
Measured: 6 hours
Secondary outcomes (2)
Preoperative iron deficiency
Preoperative messured iron deficiency
Measured: up to 4 weeks prior surgery
RBC transfusion
Number of RBC transfusions
Measured: perioperative up to hospital discharge or death (up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Aug 2025
- Primary completion30 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransfusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin N. Flinspach, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008261
- Sponsor's protocol ID
- PBM in robot cystectomies
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusion Requirements.
- ClinicalTrials.gov ID
- NCT07008261
- Acronym / sponsor ID
- PBM in robot cystectomies
- Conditions
- Transfusions, Cystectomy, Blood Loss Requiring Transfusion, Anaemia, Anaemia Postoperative, Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot assistet | – | –Robot assistet laparoscopic cystectomy |
| Conventional | – | –Conventional laparotomy for cystektomie |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a mostly oncological indication for radical cystectomy
Key inclusion criteria (1 listed)
- planned radical cystectomy
Key exclusion criteria (2 listed)
- ASA classification V
- Previously known coagulation disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
perioperative blood loss
Time frame: 6 hours
perioperative blood loss
2 secondary outcomes
Preoperative iron deficiency
Time frame: up to 4 weeks prior surgery
RBC transfusion
Time frame: perioperative up to hospital discharge or death (up to 4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Armin Flinspach N PD. Dr. med. habil., M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transfusions and Cystectomy, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armin Flinspach N PD. Dr. med. habil., M.D. (+49 69 6301 84136, armin.flinspach@unimedizin-ffm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perioperative blood loss (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.