Clinical trial NCT04688242: Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome
Official title: A Randomized, Phase 2 Study of Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome After Sphincter-preserving Proctectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Low Anterior Resection Syndrome
Keywords: rectal cancer
temporary ileostomy
low anterior resection syndrome
anal dilatation
gut microbiota
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Fifth Affiliated Hospital, Sun Yat-Sen University
First posted: 2020-12-29
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients were randomized to the treatment group (anal dilatation plus probiotics) or the control group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major LARS at 1 years after proctectomy
timeFrame: At 1 years after proctectomy
Secondary outcomes:
measure: LARS score at 1 years after proctectomy
timeFrame: At 1 years after proctectomy
measure: Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-C30 at 1 years after proctectomy
timeFrame: At 1 years after proctectomy
measure: Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-CR29 at 1 years after proctectomy
timeFrame: At 1 years after proctectomy
measure: MSKCC BFI Score at 1 years after proctectomy
timeFrame: At 1 years after proctectomy
measure: Presence of stoma at 1 years after proctectomy
timeFrame: At 1 years after proctectomy
measure: Anastomotic complications within 1 years after proctectomy
timeFrame: Within 1 years after proctectomy
measure: Time for major LARS (≥30) returning to minor or no LARS (<30) after proctectomy
timeFrame: Within 1 years after proctectomy
measure: Other complications within 1 years after proctectomy
timeFrame: Within 1 years after proctectomy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Zhuhai
country: China
facility: the Fifth Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References: