Bleeding After Robot-assisted Radical Prostatectomy: a Respective Study

Prostate Cancer Clinical Trial

— UROBLOOD01  

Official title:

Evaluation of Operative Bleeding After Robot-assisted Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06299046
• Other study ID #: 3235
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2024
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Prostate Adenocarcinoma
• Prostate Cancer

Intervention

Procedure:
• robot-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)

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of hemoglobin value on haemorrhagic complications	prevalence of post-operative haemorrhagic complications stratifying by presence/absence of anaemia (evaluated in g/dl)	4 years
Primary	Influence of hematocrit value on haemorrhagic complications	prevalence of post-operative haemorrhagic complications stratifying by pre-operative hematocrit value expressed in %	4 years
Primary	Influence of platelet count on haemorrhagic complications	prevalence of post-operative haemorrhagic complications stratifying by presence/absence of thrombocytopenia (evaluated in10^9/L)	4 years
Primary	Influence of blood group on haemorrhagic complications	prevalence of post-operative haemorrhagic complications stratifying patients by blood group	4 years
Secondary	Identification of possibile demographic and surgical predictive factors of haemorrhagic complications	Evaluation of demographic and surgical predictive factors of post-operative haemorrhagic complications	4 years