Laparoscopic Intersphincteric Resection for Ultra Low Rectal Cancer in Elderly Patients: Oncological and Functional Lon Term Outcome. A Prospective Case Control Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Quality of life of operated patients as assessed by Quality of Life Short Form Health Survey (QoL SF-36)
研究概览
简要总结
The aim of the present study is to assess if it is possible to offer intersphincteric rectal resection (IRR) to selected patients older than 70 years affected by ultra-low rectal cancer. The study, involving patients with rectal cancer at less than 5 cm from the anal verge, will compare elderly patients refusing standard sphincteric demolition and undergoing IRR, with some control groups (younger patients undergoing IRR, >70 years old patients undergoing abdominoperineal resection + colostomy in left iliac fossa, >70 years old patients undergoing abdominoperineal resection + perineal colostomy). The groups will be compared in terms of quality of life, quality of life associated to incontinence, overall survival, disease free survival and post-operative complications. This will be helpful to identify conditions for extending IRR to elderly patients. The study is run by Colo-rectal Surgery Unit at Policlinico San Matteo in Pavia (Italy) from 2009 to 2016, directly led by Dr. Sandro Zonta (principal investigator) and funded by the hospital itself.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 70 years old who were affected by rectal cancer sited lower than 5 cm from anal verge and refused abdomen-perineal treatment.
排除标准
- •Cancer extension over internal sphincteric muscle (T4) evaluated through MRI during staging work out;
- •diabetic neuropathy conditioning previous partial/total incontinence;
- •other pre-existing pathological condition affecting faecal incontinence.
结局指标
主要结局
Quality of life of operated patients as assessed by Quality of Life Short Form Health Survey (QoL SF-36)
时间窗: 6 months after discharge
QoL SF-36 score (Quality of Life Short Form Health Survey from 0 to 100, with the lower score the more disability)
Quality of life associated to incontinence as assessed by Wexner incontinence score (WiS)
时间窗: 6 months after discharge
WiS (Wexner incontinence score) from 0 to 20: higher score means worse incontinence
Quality of life associated to incontinence as assessed by Faecal incontinence quality of life scale (FIQL)
时间窗: 6 months after discharge
FIQL (Faecal incontinence quality of life scale): 29 items from 1 to 6 - the lower value the worse quality of life
次要结局
- Patients' survival(5 years)
- Disease free survival(5 years)
- Post-operative complications(6 months after discharge)
研究者
Marco Giacometti
Principal Investigator
ASL Verbano Cusio Ossola