A Randomized, Phase 2 Study of Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome After Sphincter-preserving Proctectomy
Overview
- Phase
- Phase 2
- Intervention
- Anal dilatation per anus
- Conditions
- Low Anterior Resection Syndrome
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Enrollment
- 164
- Locations
- 2
- Primary Endpoint
- Major LARS at 1 years after proctectomy
- Last Updated
- 3 years ago
Overview
Brief 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).
Detailed 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.
Investigators
Eligibility Criteria
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 ≥28.
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.
Arms & Interventions
Treatment Arm
Anal dilatation plus probiotics per anus Q3D, starting from 2 weeks after proctectomy until reduction of ileostomy.
Intervention: Anal dilatation per anus
Treatment Arm
Anal dilatation plus probiotics per anus Q3D, starting from 2 weeks after proctectomy until reduction of ileostomy.
Intervention: administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus
Outcomes
Primary Outcomes
Major LARS at 1 years after proctectomy
Time Frame: 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).
Secondary Outcomes
- 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)