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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Low Anterior Resection Syndrome

Treatments: Drug: administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus; Other: Anal dilatation per anus

Study type: Interventional

Funder types: Other

Identifiers

NCT04688242

2020ZSLYEC-187

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

Anal dilatation plus probiotics per anus Q3D, starting from 2 weeks after proctectomy until reduction of ileostomy.

Treatment:

Drug: administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus

Other: Anal dilatation per anus

Control Arm

No Intervention group

Description:

No anal dilatation or probiotics per anus was allowed, from 2 weeks after proctectomy until reduction of ileostomy.