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

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ClinicalTrials.gov Identifier: NCT04688242
Recruitment Status : Recruiting
First Posted : December 29, 2020
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Sixth Affiliated Hospital, Sun Yat-sen University

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).

Condition or disease Intervention/treatment Phase
Low Anterior Resection Syndrome Other: Anal dilatation per anus Drug: administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible patients were randomized to the treatment group (anal dilatation plus probiotics) or the control group.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 2 Study of Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome After Sphincter-preserving Proctectomy
Actual Study Start Date : February 20, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: Treatment Arm
Anal dilatation plus probiotics per anus Q3D, starting from 2 weeks after proctectomy until reduction of ileostomy.
Other: Anal dilatation per anus
Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus

Drug: administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus
Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus

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



Primary Outcome Measures :
  1. Major LARS at 2 years after proctectomy [ Time Frame: At 2 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 Outcome Measures :
  1. LARS score at 2 years after proctectomy [ Time Frame: At 2 years after proctectomy ]
    Low anterior resection syndrome (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).

  2. Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-C30 at 2 years after proctectomy [ Time Frame: At 2 years after proctectomy ]
    The European Organisation for Research and Treatment of Cancer (EORTC) developed and validated a 30-item core questionnaire (QLQ-C30) reflecting global QoL in cancer patients. QLQ-C30 comprises five functional scales, three symptom scales, a global health scale/ a quality of life scale, and six single items. All the scales and single item measures range in score from 0-100. A high score represents a higher level of functioning, a high quality of life, and a greater degree of symptoms.

  3. Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-CR29 at 2 years after proctectomy [ Time Frame: At 2 years after proctectomy ]
    QLQ-CR29 is developed by The European Organisation for Research and Treatment of Cancer (EORTC). It is a validated supplement to the QLQ-C30 specifically designed for assessment of quality of life in colorectal cancer patients. QLQ-CR29 consists of four functional scales and eighteen single items. All the scales range from 0-100. A high score represents a higher level of functioning and a greater degree of symptoms.

  4. MSKCC BFI Score at 2 years after proctectomy [ Time Frame: At 2 years after proctectomy ]
    The Memorial Sloan-Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI) score is a validated questionnaire for evaluation of bowel function after sphincter-preserving surgery. It comprises 18 items covering the frequency of various LARS symptoms and is divided into three sub-scales and four single items. It is scored on a 5-point Likert scale ranging from "always" to "never". The sub-scales scores are summarised as: A 6-item frequency sub-scale (6-30), a four-item dietary sub-scale (4-20), and a four-item urgency sub-scale (4-20). A global score can be calculated as the sum of the sub-scale scores. A total score (possible score range 18-90) can be calculated by adding all the item scores (sub-scale scores plus single item scores). A higher score indicates better bowel function.

  5. Presence of stoma at 2 years after proctectomy [ Time Frame: At 2 years after proctectomy ]
    Proportion of patients with a stoma due to failure to reduce, or a second stoma after ileostomy reduction is assessed by a professional doctor or nurse at 2 years after proctectomy.

  6. Anastomotic complications within 2 years after proctectomy [ Time Frame: Within 2 years after proctectomy ]
    Anastomotic complications is assessed by a professional doctor using Common Terminology Criteria for Adverse Events (CTCAE) classification.

  7. Time for major LARS (≥30) returning to minor or no LARS (<30) after proctectomy [ Time Frame: Within 2 years after proctectomy ]
    LARS score is assessed every 6 months after proctectomy, and the time for major LARS (≥30) returning to minor or no LARS (<30) is recorded. Low anterior resection syndrome (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).

  8. Other complications within 2 years after proctectomy [ Time Frame: Within 2 years after proctectomy ]
    Other complications is assessed by a professional doctor using Common Terminology Criteria for Adverse Events (CTCAE) classification.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ≥30.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688242


Contacts
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Contact: Ruoxu Dou, M.D. +862038254052 dourx@mail.sysu.edu.cn

Locations
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China, Guangdong
the Sixth Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 511300
Contact: Ruoxu Dou, M.D.    020-13342808275    dourx@mail.sysu.edu.cn   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
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Principal Investigator: Jun Hu, Ph.D. The Sixth Affiliated Hospital, Sun Yat-sen University
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Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04688242    
Other Study ID Numbers: 2020ZSLYEC-187
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sixth Affiliated Hospital, Sun Yat-sen University:
rectal cancer
temporary ileostomy
low anterior resection syndrome
anal dilatation
gut microbiota
Additional relevant MeSH terms:
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Aneurysm
Syndrome
Dilatation, Pathologic
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical