The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy
- Conditions
- Prostatic Neoplasm
- Interventions
- Procedure: Combined (Epidural and Spinal) AnaesthesiaProcedure: General AnaesthesiaProcedure: Open Retropubic Radical Prostatectomy
- Registration Number
- NCT05566405
- Lead Sponsor
- Sismanoglio General Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
- Diagnosed with localised prostate cancer
- Eligible for open retropubic radical prostatectomy
- Metastatic prostate cancer
- History of severe heart disease
- History of haemostasis disorders
- History of previous pelvic surgery
- History of lung disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description General Anaesthesia Open Retropubic Radical Prostatectomy Patients undergoing open retropubic radical prostatectomy under general anaesthesia Combined (Epidural and Spinal) Anaesthesia Combined (Epidural and Spinal) Anaesthesia Patients undergoing open retropubic radical prostatectomy under combined (epidural and spinal) anaesthesia General Anaesthesia General Anaesthesia Patients undergoing open retropubic radical prostatectomy under general anaesthesia Combined (Epidural and Spinal) Anaesthesia Open Retropubic Radical Prostatectomy Patients undergoing open retropubic radical prostatectomy under combined (epidural and spinal) anaesthesia
- Primary Outcome Measures
Name Time Method Blood Pressure Change Peri-operatively Measurement of patients systolic and diastolic blood pressure during the operation and post-operatively for 72 hours.
Heart Rate Change Peri-operatively Measurement of patients Heart Rate during the operation and post-operatively for 72 hours.
Operation Time Peri-operatively Time required for:
* Induction of anaesthesia
* Completion of the operation
* Post-operative time until the patient is successfully transferred to the recovery roomSurgical APGAR Score Peri-operatively Calculation of the Surgical APGAR score for each patient during surgery. The lower the score, on a scale of 1-10, the worst the prognosis of the patient.
SAS is calculated using three variables:
* Estimated blood loss (on a 0-3 scale, 0 points \>1000 ml, 1 point 601-1000ml, 2 points 101-600 ml, 3 points \<100ml)
* Lowest mean arterial pressure (on a 0-3 scale, 0 points \<40 mmHg, 1 point 40-54 mmHg, 2 points 55-69 mmHg, 3 points \>70 mmHg)
* Lowest heart rate (on a 0-4 scale, 0 points \>85 bpm, 1 points 76-85 bpm, 2 points 66-75 bmp, 3 points 56-65 bmp, 4 points \<55 bmp) during surgery.Blood Loss During Surgery Peri-operatively Measured from suction contents intra-operatively in ml
Change from 6-month PSA Levels at 12-months 12 months post-operative Measurement of Prostatic Specific Antigen (PSA) levels at 12 post-operation to detect any biochemical recurrence
Haemoglobin Change Peri-operatively Haemoglobin measurement before the operation and at 12-, 24- and 48-hours post-operatively, in g/dL
Change From Baseline PSA Levels at 6-months 6 months post-operative Measurement of Prostatic Specific Antigen (PSA) levels at 6 to establish a PSA nadir value
Complication Rate Peri-operatively and up to 1 year after the operation Complications related to the procedure:
* Intraoperative bleeding
* Post-operative bleeding
* Bowel perforation
* Cardiovascular
* Respiratory
Complications related to the anaesthesia technique performed:
* Post-operative headache
* Nausea and vomiting
* Any signs of potential nerve damage (manifested as inability to gain leg motility)Pain Assessed by the VAS Scale Peri-operatively Measured using a pain Visual Analogue Scale (VAS) at 6-, 24- and 48-hours after the operation.
VAS is a self-reporting pain scale based on a 0 to 10-point system, with each point measuring 10mm on a linear line. Every patient was asked to indicate his pain levels from "No Pain" (equals 0) to "Worst Pain Imaginable" (equals 10).
- Secondary Outcome Measures
Name Time Method Post-operative Urinary Incontinence 1 year after the operation Measured using the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form at 12 months post-surgery.
The Questionnaire is consisted of 4 questions:
* Frequency "How often do you leak urine?" on a scale of 0 (never) to 5 (all the time)
* Amount of leakage "How much urine do you leak?" on a scale to 0 (none) to 3 (a large amount)
* Overall impact on quality of life "How much does it interfere with your life?" on a scale of 0 (not at all) to 10 (a great deal)
* Timing of leakage "When does urine leak?"Patient Satisfaction Assessed by the Short Assessment of Patient Satisfaction (SAPS) Questionnaire Peri-operative Satisfaction, using the Short Assessment of Patient Satisfaction (SAPS) Questionnaire, is measured in a scale of 0 to 28, with 0 to 10 equals to "Very Dissatisfied", 11-18 equals to "Dissatisfied", 19-26 equals to "Satisfied" and 27-28 equals to "Very Satisfied"
Change from Baseline Erectile Function after Radical Prostatectomy Up to 1 year after the operation Measured using the International Index of Erectile Function (IIEF-5) questionnaires pre-operatively and at 3-, 6- and 12-months post-surgery.
The test is composed of 5 questions with 5 points for each question. Patients are evaluated accordingly:
* Score 22 or more = No Erectile Disfunction
* Score 17-21 = Mild Erectile Disfunction
* Score 12-16 = Mild to moderate Erectile Disfunction
* Score 8-11 = Moderate Erectile Disfunction
* Score 7 or less = Severe Erectile Disfunction
Results will be:
* Analysed and compared to evaluate any potential difference of the two methods of anaesthesia, on post-operational erectile function
* Analysed comparing pre-operation with post-operation questioners overall, to evaluate erectile disfunction after radical prostatectomy regardless of method of anaesthesia.Total Hospital Stay Peri-operative Days until patient discharge from the hospital.
Trial Locations
- Locations (1)
Sismanoglio General Hospital
🇬🇷Maroúsi, Attiki, Greece