Comparative Study of the Effects of Combined Spinal Anaesthesia and General Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy in Patients With Localised Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Blood Pressure Change
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with localised prostate cancer
- •Eligible for open retropubic radical prostatectomy
排除标准
- •Metastatic prostate cancer
- •History of severe heart disease
- •History of haemostasis disorders
- •History of previous pelvic surgery
- •History of lung disease
结局指标
主要结局
Blood Pressure Change
时间窗: Peri-operatively
Measurement of patients systolic and diastolic blood pressure during the operation and post-operatively for 72 hours.
Heart Rate Change
时间窗: Peri-operatively
Measurement of patients Heart Rate during the operation and post-operatively for 72 hours.
Operation Time
时间窗: Peri-operatively
Time required for: * Induction of anaesthesia * Completion of the operation * Post-operative time until the patient is successfully transferred to the recovery room
Surgical APGAR Score
时间窗: 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
时间窗: Peri-operatively
Measured from suction contents intra-operatively in ml
Change from 6-month PSA Levels at 12-months
时间窗: 12 months post-operative
Measurement of Prostatic Specific Antigen (PSA) levels at 12 post-operation to detect any biochemical recurrence
Haemoglobin Change
时间窗: 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
时间窗: 6 months post-operative
Measurement of Prostatic Specific Antigen (PSA) levels at 6 to establish a PSA nadir value
Complication Rate
时间窗: 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
时间窗: 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).
次要结局
- Post-operative Urinary Incontinence(1 year after the operation)
- Patient Satisfaction Assessed by the Short Assessment of Patient Satisfaction (SAPS) Questionnaire(Peri-operative)
- Total Hospital Stay(Peri-operative)
- Change from Baseline Erectile Function after Radical Prostatectomy(Up to 1 year after the operation)
研究者
Konstantinos Pikramenos
Principal Investigator, Urology Resident, MD
Sismanoglio General Hospital