Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome

A Randomized, Phase 2 Study of Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome After Sphincter-preserving Proctectomy

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).

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.

Inclusion Criteria:

1. A voluntarily signed and dated informed consent form;
2. ECOG Performance status is 0 or 1;
3. Age at enrollment is of 18 to 80 years old.;
4. R0 sphincter-preserving proctectomy and temporary ileostomy for rectal cancer;
5. The distance from anastomosis to anal verge is ≤7cm;
6. Both the anastomosis and the ileostomy is intact at 2 weeks follow-up after proctectomy;
7. Baseline LARS score before proctectomy is <30;
8. The preoperatively predicted LARS (POLARS) score after proctectomy is ≥28.

Exclusion Criteria:

1. R1/R2 resection or untreated metastases;
2. 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;
3. Severe morbidity with life expectancy less than 2 years;
4. Any toxicity of CTCAE grade 2 or above due to previous treatment that have not resolved, except for anemia, alopecia, skin pigmentation;
5. Anastomotic leak within 2 weeks after proctectomy, suspected by clinical symptoms, digital rectal examination, or imaging;
6. Complications of the ileostomy within 2 weeks after proctectomy, leading to premature takedown of the stoma (within 2 months after surgery);
7. Any medical condition that may affect the safety and compliance of the subject.