A Prospective, Randomized, Open, Parallel Trial of Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome in Rectal Cancer Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants with major low anterior resection syndrome score (LARS score)
研究概览
简要总结
Bowel dysfunction after rectal cancer resection comprises a vast array of bowel symptoms and associated quality-of-life impairment, collectively termed as low anterior resection syndrome (LARS). There are 40%-60% patients who suffer from major LARS after sphincter-preserving surgery. No consensus exists for LARS treatment or prevention. Transanal irrigation (TAI) was reported to play a helpful role in the management of major LARS and fecal incontinence. However, the preventive effect and daily accessibility need further confirmation. In this randomized trial, TAI compared with best support treatment, is used in patients who received curative low anterior resection for rectal cancer with diverting stoma, after completion of the stoma reversal. The primary outcome is the occurrence of major LARS after 6 months of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old
- •Curative low anterior resection for rectal cancer with diverting stoma
- •Stoma closure within 1 month
- •Preoperative radiotherapy or height of anastomosis less than 5 cm from anal verge
- •No evidence of anastomotic leakage or severe stenosis
排除标准
- •Tumor recurrence or distant metastasis
- •Secondary operation with stoma
- •Prior disease impairing bowel function except for rectal cancer
- •Any contraindication for transanal irrigation
- •Pregnant or nursing
- •Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease
- •Cognitive or psychological disorder
结局指标
主要结局
Number of participants with major low anterior resection syndrome score (LARS score)
时间窗: at the time of 6 months since the start of treatment
次要结局
- Number of participants with major low anterior resection syndrome score (LARS score)(at the time of 1, 3, 12 months since the start of treatment)
- Bowel function impairment(at the time of 6, 12 months since the start of treatment)
- Fecal continence impairment(at the time of 6, 12 months since the start of treatment)
- Quality of life impairment assessed by Short Form 36 (SF-36)(at the time of 6, 12 months since the start of treatment)