Low Anterior Resection SyndromePhase 2PILLARSNCT04688242
Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome
A Phase 2 study testing Anal dilatation per anus and administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus in people with Low Anterior Resection Syndrome, run by Sixth Affiliated Hospital, Sun Yat-sen University at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- Anal dilatation per anus and administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesChina
- Study dates
- 20 Feb 2021to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630
Rongkang Huang, M.D., 020-13480218647, huangrk3@mail.sysu.edu.cn
- Recruiting
the Fifth Affiliated Hospital, Sun Yat-Sen University
Zhuhai, Guangdong, 519000
Ruoxu Dou, M.D., 020-13342808275, dourx@mail.sysu.edu.cn
About this study
Official title: A Randomized, Phase 2 Study of Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome After Sphincter-preserving Proctectomy
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).
Read the 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.
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- Anal dilatation per anus, administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus
- Keywords
- rectal cancer, temporary ileostomy, low anterior resection syndrome, anal dilatation, gut microbiota
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal dilatation per anusOther
Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus
administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anusDrug
Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Anal dilatation plus probiotics per anus Q3D, starting from 2 weeks after proctectomy until reduction of ileostomy. Receives: Other: Anal dilatation per anus; Drug: administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus |
| Control Arm | No intervention | No anal dilatation or probiotics per anus was allowed, from 2 weeks after proctectomy until reduction of ileostomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 1 years after proctectomy
Secondary outcomes (8)
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).
Measured: At 1 years after proctectomy
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.
Measured: At 1 years after proctectomy
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.
Measured: At 1 years after proctectomy
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.
Measured: At 1 years after proctectomy
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.
Measured: At 1 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.
Measured: Within 1 years after proctectomy
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).
Measured: Within 1 years after proctectomy
Other complications within 1 years after proctectomy
Other complications is assessed by a professional doctor using Common Terminology Criteria for Adverse Events (CTCAE) classification.
Measured: Within 1 years after proctectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start20 Feb 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients were randomized to the treatment group (anal dilatation plus probiotics) or the control group.
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688242
- Sponsor's protocol ID
- 2020ZSLYEC-187
- Acronym
- PILLARS
- Status last verified
- Dec 2021
- First submitted
- 13 Dec 2020
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 2 Study of Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome After Sphincter-preserving Proctectomy
- ClinicalTrials.gov ID
- NCT04688242
- Acronym / sponsor ID
- PILLARS / 2020ZSLYEC-187
- Conditions
- Low Anterior Resection Syndrome
- Keywords
- rectal cancer, temporary ileostomy, low anterior resection syndrome, anal dilatation, gut microbiota
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients were randomized to the treatment group (anal dilatation plus probiotics) or the control group.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Other: Anal dilatation per anus, Drug: administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anusAnal dilatation plus probiotics per anus Q3D, starting from 2 weeks after proctectomy until reduction of ileostomy. |
| Control Arm | No intervention | –No anal dilatation or probiotics per anus was allowed, from 2 weeks after proctectomy until reduction of ileostomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anal dilatation per anusDigital anal dilatation through anastomosis, with concomitant administration of probiotics per anus | Other | Treatment Arm |
| administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anusDigital anal dilatation through anastomosis, with concomitant administration of probiotics per anus | Drug | Treatment Arm |
Primary outcome
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).
8 secondary outcomes
LARS score at 1 years after proctectomy
Time frame: At 1 years after proctectomy
Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-C30 at 1 years after proctectomy
Time frame: At 1 years after proctectomy
Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-CR29 at 1 years after proctectomy
Time frame: At 1 years after proctectomy
MSKCC BFI Score at 1 years after proctectomy
Time frame: At 1 years after proctectomy
Presence of stoma at 1 years after proctectomy
Time frame: At 1 years after proctectomy
Anastomotic complications within 1 years after proctectomy
Time frame: Within 1 years after proctectomy
Time for major LARS (≥30) returning to minor or no LARS (<30) after proctectomy
Time frame: Within 1 years after proctectomy
Other complications within 1 years after proctectomy
Time frame: Within 1 years after proctectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anal dilatation per anus and administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus in people with Low Anterior Resection Syndrome, run by Sixth Affiliated Hospital, Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruoxu Dou, M.D. (+86-756-2528708, dourx@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major LARS at 1 years after proctectomy (time frame: At 1 years after proctectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.