A Randomized, Phase 2 Study of Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome After Sphincter-preserving Proctectomy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Major LARS at 1 years after proctectomy
研究概览
简要总结
This is randomized, phase 2 trial in patients with rectal cancer undergoing sphincter-preserving proctectomy and temporary ileostomy, to explore the effects of anal dilatation plus probiotics administered per anus before ileostomy reduction in relieving postoperative bowel dysfunction known as low anterior resection syndrome (LARS).
详细描述
Approximately 60-90% of patients undergoing sphincter-sparing proctectomy complain of postoperative bowel dysfunction including incontinence, frequency, clustering, and urgency, collectively known as low anterior resection syndrome (LARS). Literatures and our previous data have demonstrated that diverting ileostomy is an independent risk factor for major LARS. This is a randomized, phase 2 trial in patients with rectal cancer who underwent sphincter-preserving proctectomy and ileostomy. This study will explore the effects of anal dilatation plus probiotics administered per anus in relieving the symptoms of LARS.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A voluntarily signed and dated informed consent form;
- •ECOG Performance status is 0 or 1;
- •Age at enrollment is of 18 to 80 years old.;
- •R0 sphincter-preserving proctectomy and temporary ileostomy for rectal cancer;
- •The distance from anastomosis to anal verge is ≤7cm;
- •Both the anastomosis and the ileostomy is intact at 2 weeks follow-up after proctectomy;
- •Baseline LARS score before proctectomy is <30;
- •The preoperatively predicted LARS (POLARS) score after proctectomy is ≥28.
排除标准
- •R1/R2 resection or untreated metastases;
- •Any synchronous or metachronous malignancies, except for cancers that have received curative treatment and have not recurred for more than 5 years, or carcinoma in situ that have been cured by appropriate treatment;
- •Severe morbidity with life expectancy less than 2 years;
- •Any toxicity of CTCAE grade 2 or above due to previous treatment that have not resolved, except for anemia, alopecia, skin pigmentation;
- •Anastomotic leak within 2 weeks after proctectomy, suspected by clinical symptoms, digital rectal examination, or imaging;
- •Complications of the ileostomy within 2 weeks after proctectomy, leading to premature takedown of the stoma (within 2 months after surgery);
- •Any medical condition that may affect the safety and compliance of the subject.
研究组 & 干预措施
Treatment Arm
Anal dilatation plus probiotics per anus Q3D, starting from 2 weeks after proctectomy until reduction of ileostomy.
干预措施: Anal dilatation per anus (Other)
Treatment Arm
Anal dilatation plus probiotics per anus Q3D, starting from 2 weeks after proctectomy until reduction of ileostomy.
干预措施: administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus (Drug)
结局指标
主要结局
Major LARS at 1 years after proctectomy
时间窗: At 1 years after proctectomy
Proportion of patients with Low anterior resection syndrome (LARS) score ≥30. LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).
次要结局
- Presence of stoma at 1 years after proctectomy(At 1 years after proctectomy)
- Anastomotic complications within 1 years after proctectomy(Within 1 years after proctectomy)
- LARS score at 1 years after proctectomy(At 1 years after proctectomy)
- Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-C30 at 1 years after proctectomy(At 1 years after proctectomy)
- Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-CR29 at 1 years after proctectomy(At 1 years after proctectomy)
- MSKCC BFI Score at 1 years after proctectomy(At 1 years after proctectomy)
- Time for major LARS (≥30) returning to minor or no LARS (<30) after proctectomy(Within 1 years after proctectomy)
- Other complications within 1 years after proctectomy(Within 1 years after proctectomy)