Bleeding After Robot-assisted Radical Prostatectomy: a Respective Study

NCT ID: NCT06299046

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 194 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-01-01

Brief 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.

Conditions

Prostate Cancer; Bleeding; Prostate Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

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)

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Elisa De Lorenzis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Countries

Italy

Other Identifiers

3235

Identifier Type: -

Identifier Source: org_study_id