Back to resultsAnal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome (PILLARS)
Primary Purpose
Low Anterior Resection Syndrome
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anal dilatation per anus
administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus
Sponsored by
About this trial
This is an interventional treatment trial for Low Anterior Resection Syndrome focused on measuring rectal cancer, temporary ileostomy, low anterior resection syndrome, anal dilatation, gut microbiota
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.
Sites / Locations
- the Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting
- the Fifth Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Arm
Control Arm
Arm Description
Anal dilatation plus probiotics per anus Q3D, starting from 2 weeks after proctectomy until reduction of ileostomy.
No anal dilatation or probiotics per anus was allowed, from 2 weeks after proctectomy until reduction of ileostomy.
Outcomes
Primary Outcome Measures
Major LARS 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 Outcome Measures
LARS score at 1 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).
Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-C30 at 1 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.
Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-CR29 at 1 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.
MSKCC BFI Score at 1 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.
Presence of stoma at 1 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.
Anastomotic complications within 1 years after proctectomy
Anastomotic complications is assessed by a professional doctor using Common Terminology Criteria for Adverse Events (CTCAE) classification.
Time for major LARS (≥30) returning to minor or no LARS (<30) 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).
Other complications within 1 years after proctectomy
Other complications is assessed by a professional doctor using Common Terminology Criteria for Adverse Events (CTCAE) classification.
Full Information
NCT ID
NCT04688242
First Posted
December 13, 2020
Last Updated
December 2, 2022
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT04688242
Brief Title
Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome
Acronym
PILLARS
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Anterior Resection Syndrome
Keywords
rectal cancer, temporary ileostomy, low anterior resection syndrome, anal dilatation, gut microbiota
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients were randomized to the treatment group (anal dilatation plus probiotics) or the control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Anal dilatation plus probiotics per anus Q3D, starting from 2 weeks after proctectomy until reduction of ileostomy.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
No anal dilatation or probiotics per anus was allowed, from 2 weeks after proctectomy until reduction of ileostomy.
Intervention Type
Other
Intervention Name(s)
Anal dilatation per anus
Intervention Description
Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus
Intervention Type
Drug
Intervention Name(s)
administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus
Intervention Description
Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus
Primary Outcome Measure Information:
Title
Major LARS at 1 years after proctectomy
Description
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).
Time Frame
At 1 years after proctectomy
Secondary Outcome Measure Information:
Title
LARS score at 1 years after proctectomy
Description
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).
Time Frame
At 1 years after proctectomy
Title
Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-C30 at 1 years after proctectomy
Description
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.
Time Frame
At 1 years after proctectomy
Title
Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-CR29 at 1 years after proctectomy
Description
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.
Time Frame
At 1 years after proctectomy
Title
MSKCC BFI Score at 1 years after proctectomy
Description
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.
Time Frame
At 1 years after proctectomy
Title
Presence of stoma at 1 years after proctectomy
Description
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.
Time Frame
At 1 years after proctectomy
Title
Anastomotic complications within 1 years after proctectomy
Description
Anastomotic complications is assessed by a professional doctor using Common Terminology Criteria for Adverse Events (CTCAE) classification.
Time Frame
Within 1 years after proctectomy
Title
Time for major LARS (≥30) returning to minor or no LARS (<30) after proctectomy
Description
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).
Time Frame
Within 1 years after proctectomy
Title
Other complications within 1 years after proctectomy
Description
Other complications is assessed by a professional doctor using Common Terminology Criteria for Adverse Events (CTCAE) classification.
Time Frame
Within 1 years after proctectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruoxu Dou, M.D.
Phone
+86-756-2528708
Email
dourx@mail.sysu.edu.cn
Facility Information:
Facility Name
the Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongkang Huang, M.D.
Phone
020-13480218647
Email
huangrk3@mail.sysu.edu.cn
Facility Name
the Fifth Affiliated Hospital, Sun Yat-Sen University
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruoxu Dou, M.D.
Phone
020-13342808275
Email
dourx@mail.sysu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome
We'll reach out to this number within 24 hrs