The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy

Sismanoglio General Hospital

Status: Completed

Conditions: Prostatic Neoplasm

Treatments: Procedure: Open Retropubic Radical Prostatectomy; Procedure: Combined (Epidural and Spinal) Anaesthesia; Procedure: General Anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05566405

PN 20511/14.10.2020

Details and patient eligibility

About

Prostate cancer is one of the most commonly diagnosed neoplasm in men worldwide. The gold standard of therapy is radical prostatectomy, a wide surgical excision of the neoplasm and can be performed either open, laparoscopic or robotic. The open retropubic approach, still performed today, can be completed under either general anaesthesia or combined (spinal/epidural) anaesthesia without any clear guideline on which one should be preferred.

In this study the investigators aim to evaluate general anaesthesia and combined (spinal/ epidural) anaesthesia in patients undergoing open retropubic radical prostatectomy and define whether these may have an impact on the oncological outcome and safety of the procedure.

Enrollment: 60 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with localised prostate cancer
• Eligible for open retropubic radical prostatectomy

Exclusion criteria

• Metastatic prostate cancer
• History of severe heart disease
• History of haemostasis disorders
• History of previous pelvic surgery
• History of lung disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

General Anaesthesia

Active Comparator group

Description:

Patients undergoing open retropubic radical prostatectomy under general anaesthesia

Treatment:

Procedure: General Anaesthesia

Procedure: Open Retropubic Radical Prostatectomy

Combined (Epidural and Spinal) Anaesthesia

Active Comparator group

Description:

Patients undergoing open retropubic radical prostatectomy under combined (epidural and spinal) anaesthesia

Treatment:

Procedure: Open Retropubic Radical Prostatectomy

Procedure: Combined (Epidural and Spinal) Anaesthesia