Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery - An Italian Multicentre Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 主要终点
- Compare the effectiveness of two treatment regimens, initiated within different time frames following ostomy closure, in reducing the number of bowel movements in 24 hours.
研究概览
简要总结
This study aims to evaluate the optimal timing of trans-anal irrigation (TAI) for participants with low anterior resection syndrome (LARS) who have undergone surgery for rectal cancer.
The main question it aims to answer is:
"Can starting TAI within three months of stoma closure reduce the number of daily bowel movements in people who have undergone rectal surgery?" Researchers will compare the outcomes for participants who start TAI within the first three months with those who start after three months, to see if early TAI can reduce the number of daily bowel movements more effectively than starting later.
The study will also determine whether early TAI can improve typical bowel symptoms, enhance quality of life, and increase satisfaction with treatment as much as when it is performed more than three months after stoma closure.
Participants will:
- Undergo a preliminary visit to assess their eligibility to participate
- Undergo training to understand how to use the device correctly
- Perform regular TAI
- Undergo four control visits at 1, 3, 6 and 9 months after the start of treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 18 years
- •Colorectal resection for rectal cancer with a protective ostomy
- •Integrity of the colorectal or coloanal anastomosis, as confirmed by each center's standard procedure
- •LARS score > 30 (major LARS)
- •Not previously treated with TAI (except for enemas)
- •Completion of training on TAI irrigation by trained medical/nursing staff
- •Use of only the Peristeen® Plus device for TAI
- •Written informed consent
排除标准
- •Neurological diseases
- •Psychiatric disorders
- •Refusal to consent to follow-up
- •Current or planned pregnancy
- •Known allergy to latex
- •Presence of contraindications as outlined in the device's Instructions for Use (IFU), such as ischemic colitis, acute inflammatory bowel disease, or acute diverticulitis.
结局指标
主要结局
Compare the effectiveness of two treatment regimens, initiated within different time frames following ostomy closure, in reducing the number of bowel movements in 24 hours.
时间窗: From baseline to 3 months
The difference in the change from baseline (V0) in the number of bowel movements (i.e. defecations) in 24 hours at 3 months after stoma closure (V2) between the early TAI group and the late TAI-treated group.
次要结局
- Efficacy of early administration of TAI in reducing the symptoms of LARS in the longterm period (up to 9 months).(From baseline to 9 months)
- Efficacy of early administration of TAI in prevent LARS chronicity (prevent the increase of specific symptoms of LARS at all time points).(From baseline to 9 months)
- Efficacy of early administration of TAI improving quality of life at all time points(From baseline to 9 months)
- Efficacy of early administration of TAI improving patient satisfaction at all time points(From baseline to 9 months)
- Evaluate how various factors, such as the timing of TAI initiation, type of anastomosis, prior neoadjuvant radio-chemotherapy, and other patient baseline characteristics, influence LARS symptoms(From baseline to 9 months)
研究者
Simona Ascanelli
General Surgeon at University Hospital of Ferrara
University Hospital of Ferrara