Randomised Controlled Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Sepsis
研究概览
简要总结
This study is a prospective randomised controlled study of urinary bladder cancer patients presented to urology unit at National Cancer Institute; Cairo University.
详细描述
The study will randomise 60 patients to one of two arms; laparoscopic-assisted radical cystectomy and open radical cystectomy. The focus of the study will be a comparison of both approaches on the patients' peri-operative outcome.
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
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with transitional cell carcinoma, squamous cell carcinoma and urinary bladder adenocarcinoma.
- •Patients fit for surgery (ECOG Performance Status 0,1).
排除标准
- •Patients with medical comorbidities that preclude surgical management or minimally invasive techniques.
- •Patients with advanced hydronephrosis or renal failure.
- •Patients refusing surgery.
- •Patients with urinary bladder cancer invading bladder neck or prostatic urethra.
- •Patients with metastatic urinary bladder cancer.
- •Patients who received prior pelvic radiotherapy.
- •Patients refusing randomization and/or participation in the trial.
结局指标
主要结局
Sepsis
时间窗: Up to 4 weeks
Infection triggering a systematic immune response
Operative time
时间窗: During surgery
OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion.
Visceral injury
时间窗: During surgery
Any organ injury encountered during the operation.
Urine leak
时间窗: Up to 4 weeks
Leakage of urine from urinary enteric anastomosis
Wound dehiscence, infection.
时间窗: Up to 4 weeks
Wound gaping, evisceration or infection.
Venous thromboembolism
时间窗: Up to 2 months
DVT or pulmonary embolism
Blood loss
时间窗: During surgery
EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs.
Time to oral intake
时间窗: Immediate post-operative period
Measured in days
Conversion rate
时间窗: During surgery
Rate of conversion from laparoscopy to open surgery
Re-admission rate.
时间窗: Intra-operative to sixth months.
Re-hospitalization requirement.
Opioid requirements.
时间窗: During surgery through first post-operative week.
Requirement, dose and duration of narcotic analgesia.
Length of hospital stay
时间窗: Immediate post-operative period.
LOS as measured in days
Enteric fistula
时间窗: Up to 4 weeks
Leakage of intestinal contents due to failure of entero-enteric anastomosis
次要结局
- Lymph node retrieval(Within 10 days post surgery.)
- pN stage(Within 10 days post surgery.)
- pT stage(Within 10 days post surgery.)
- Surgical margins(Within 10 days post surgery)
- Histological grade(Within 10 days post surgery)
研究者
Ahmed Abdelbary Ali
Lecturer of Surgical Oncology
Cairo University