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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    164
  • sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
Updated on 26 March 2021

Summary

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).

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.

Details
Condition Low Anterior Resection Syndrome
Treatment Anal dilatation per anus, administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus
Clinical Study IdentifierNCT04688242
SponsorSixth Affiliated Hospital, Sun Yat-sen University
Last Modified on26 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 30

Exclusion Criteria

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
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