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Completed

NCT Number: NCT06299046

Bleeding After Robot-assisted Radical Prostatectomy: a Respective Study

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Robot-Assisted Radical Prostatectomy

Procedure

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)

Primary outcomes

  1. Influence of hemoglobin value on haemorrhagic complications

    Time frame: 4 years

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

  2. Influence of hematocrit value on haemorrhagic complications

    Time frame: 4 years

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

  3. Influence of platelet count on haemorrhagic complications

    Time frame: 4 years

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

  4. Influence of blood group on haemorrhagic complications

    Time frame: 4 years

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

Secondary outcomes

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

    Time frame: 4 years

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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

Evaluation of Operative Bleeding After Robot-assisted Radical Prostatectomy

Acronym: UROBLOOD01

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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