Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 12
- 主要终点
- Quality of life outcome
研究概览
简要总结
Sphincter preservation surgery in low rectal cancer has been increased due to better understanding of tumor biology and advances in surgical technology. Furthermore, a majority of patients prefer sphincter preservation rather than living with permanent colostomy. But it is not clear whether sphincter preservation is directly related with better quality of life. There have been many studies comparing sphincter preservation surgery and abdominoperineal resection in many aspects including oncologic and functional outcomes, and the quality of life. However, the conclusion remains controversial because of the different results between studies.
详细描述
This prospective study was designed to compare the quality of life after sphincter saving surgery and abdominoperineal resection. Because of ethical issues, it is difficult to conduct as a randomized trial. On the basis of tumor location, extent, and preoperative anal function, patient will be attributed to two different operative method groups. On the assumption that 10% of the patients are lost to follow-up at 1 year, at least 74 patients undergoing APR and 220 patients undergoing SPS will be recruited. The study will be continued until the target sample size will be achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low rectal cancer (5cm from anal verge by surgeon's digital rectal exam / rigid rectoscopy)
- •Patient who understands and accepts to sign the informed consent form
- •Confirmed preoperative colonoscopic biopsy (adenocarcinoma)
- •Proper bone marrow function
- •Proper renal function
- •Proper liver function
- •No severe comorbidity
排除标准
- •Metastatic lesion detected in preoperative assessment
- •Previous history of cancer disease. (except patients with skin cancer)
- •Severe heart disease, congestive heart disease.
- •Severe lung disease, respiratory failure.
- •Mental illness.
- •Invasion to prostate, bladder and combined resection needed (partial or radical.• Legally prohibited for clinical trial.
- •Pregnancy or breast feeding.
- •Previous disease or disability expected to influence the assessment of postoperative quality of life.
结局指标
主要结局
Quality of life outcome
时间窗: 3 years
Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
次要结局
- Oncologic outcomes(5 years)
- Bladder function(3 years)
- Sexual function(3 years)
- Anal function(3 years)
研究者
Sung-Bum Kang
Director of Colorectal Cancer Center, Principal Investigator, Professor
Seoul National University Bundang Hospital