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CompletedNCT06299046UROBLOOD01Updated Mar 8, 2024

Bleeding After Robot-assisted Radical Prostatectomy: a Respective Study

An observational study in Prostate Cancer, Bleeding and Prostate Adenocarcinoma, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Completed at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-08.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
194
Ages
18 Years and older
Sex
Male
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Study summary

Nowadays robot-assisted radical prostatectomy (RARP) has become the standard surgical treatment for localised prostate cancer. The robotic approach has been proven superior to open retropubic prostatectomy (ORP) in terms of surgical-related morbidity: RARP has in fact been associated with significantly lower estimated blood loos (EBL), lower transfusion rate, less length of stay, shorter catheterization time, lower risk of Clavien-Dindo grade II and III complications, lower risk of vesicourethral anastomotic stricture and less post-operative pain. The optimal anatomical visualisation and the extraordinary maneuverability, along with the tamponade effect of the pneumoperitoneum, are surely to be deemed responsible of this statistically significant differences.

However, to this day no study has ever investigated the prognostic significance of haematological parameters in terms of predicting perioperative bleeding risk in patients undergoing RARP.

Therefore, the investigators conducted a retrospective non-interventional cohort study to gather evidence concerning the impact of anemia and thrombocytopenia on bleeding risk following this surgical procedure. Furthermore, the investigators evaluated associations between demographical, pathological and surgical factors and hemorrhagic complications.

The investigators retrospectively evaluated all the patients that underwent robot-assisted radical prostatectomy in our Urology Unit from the 1st of January 2017 to the 31th of December 2020. The investigators collected demographic, clinical and pathological data from the medical records of these patients, with particular attention to other known risk-factors for RARP-associated bleeding (e.g.: volume of the prostate, body mass index, smoking status, nerve sparing technique).

Complications were analyzed according to the Clavien- Dindo classification. Bleeding was assessed by considering both the hemoglobin (Hb) drop after surgery and the fluid intraoperatively collected in the suction canister, with all the due adjustments. Moreover, post-operative haemorrhagic complications were evaluated.

The investigators included patients not younger than 18 years old, of which records of a pre-operative full blood count in the 30 days prior to the surgery along with a full blood count the day after were available.

Criteria for exclusion were a history of congenital coagulopathies and/or congenital thrombocytopenia and patients that underwent salvage radical prostatectomy after radiation therapy.

Statistics: EBL and operative time learning curve is studied. Clinical, pathological, intraoperative risk factors analysis for higher EBL is performed by linear regression modelling. Factors are evaluated independently and jointly. Association between each factor above and post-operative outcomes (i.e. post-op bleeding, need of transfusion and hematuria) is also assessed.

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Conditions studied

  • Prostate Cancer
  • Bleeding
  • Prostate Adenocarcinoma

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03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 194 is above the median of 150 across 893 observational studies indexed under Hemorrhage.

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Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  • Consecutive patients aged 18 years or older undergoing RARP at the Urology Unit between 1 January 2017 and 31 December 2020.

Inclusion criteria

  • Consecutive patients aged 18 years or older undergoing RARP at the Urology Unit between 1 January 2017 and 31 December 2020.
  • All patients with a pre-operative complete blood count (CBC) in the last 30 days before surgery and a postoperative first-day CBC will be included.

Exclusion criteria

Exclusion Criteria:

  • Patients with congenital coagulation defects or congenital thrombocytopenias
  • Patients undergoing salvage radical prostatectomy (post-radiotherapy)
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
194 participants (actual)
Patient registry
No

Interventions

  • Procedurerobot-assisted radical prostatectomy

    surgical removal of the entire prostate and the seminal vesicles, followed by the vescico-urethral anastomosis to restore the continuity of the lower urinary tract performed using Da Vinci Si and Xi Surgical System (Intuitive Surgical, Sunnyvale, California, USA)

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What researchers measure

Primary outcomes

  1. Influence of hemoglobin value on haemorrhagic complications

    prevalence of post-operative haemorrhagic complications stratifying by presence/absence of anaemia (evaluated in g/dl)

    Time frame: 4 years

  2. Influence of hematocrit value on haemorrhagic complications

    prevalence of post-operative haemorrhagic complications stratifying by pre-operative hematocrit value expressed in %

    Time frame: 4 years

  3. Influence of platelet count on haemorrhagic complications

    prevalence of post-operative haemorrhagic complications stratifying by presence/absence of thrombocytopenia (evaluated in10\^9/L)

    Time frame: 4 years

  4. Influence of blood group on haemorrhagic complications

    prevalence of post-operative haemorrhagic complications stratifying patients by blood group

    Time frame: 4 years

Secondary outcomes

  1. Identification of possibile demographic and surgical predictive factors of haemorrhagic complications

    Evaluation of demographic and surgical predictive factors of post-operative haemorrhagic complications

    Time frame: 4 years

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Study locations

1 site
  • IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico
    Milan, 20122, Italy
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06299046
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Responsible party
Elisa De Lorenzis (Principal Investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico) — Principal investigator
First posted
Mar 7, 2024
Start date
Dec 1, 2022
Primary completion
Jan 1, 2023
Completion
Jan 1, 2023
Last update
Mar 8, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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