Open Versus Laparoscopic Radical Cystectomy for Invasive Bladder Cancer in the Elderly Patient. A Multicenter Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Complication rate
研究概览
简要总结
To date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in the elderly patients, both in terms of functional and clinical outcome measures. A more meaningful comparison of the two modalities is that of a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with a histologically proven diagnosis of transitional cell carcinoma of the bladder
- •Patients with an indication to ureterocutaneostomy or ileal conduit
- •ECOG Performance Status ≤ 2
- •WBC count ≥4,000/μL; platelet count ≥150,000/μL
- •4.Recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC
排除标准
- •Patients who have previously undergone lower abdominal and/or pelvic surgery for invasive cancer (i.e. radical prostatectomy, large bowel surgeries with or without ileal/colonic conduit)
- •Patients who have previously received any pelvic irradiation
- •Patients with a synchronous upper urinary tract malignancy requiring a nephroureterectomy concomitant to cystectomy
- •Patients candidates for a palliative cystectomy (i.e. recurrent haematuria which cannot be treated by endoscopy)
- •Patients with a histologically proven diagnosis of bladder adenocarcinoma, squamous cell carcinoma, and small cell carcinoma
研究组 & 干预措施
Laparoscopic radical cystectomy
Surgery: Laparoscopic radical cystectomy with open urinary diversion
干预措施: Laparoscopic radical cystectomy with open urinary diversion (Procedure)
Open radical cystectomy
Surgery: Open radical cystectomy with open urinary diversion
干预措施: Open radical cystectomy with open urinary diversion (Procedure)
结局指标
主要结局
Complication rate
时间窗: 24 months
Comparison of the complication rate among the two cohorts of patients under investigation according to the Clavien classification.
次要结局
- Health related quality of life(24 months)
研究者
Pagliarulo Vincenzo
Medical Doctor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari