Low Anterior Resection SyndromeTAILARSNCT04758195
Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome
A study testing Transanal irrigation and Best supportive therapy in people with Low Anterior Resection Syndrome, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Bowel dysfunction after rectal cancer resection comprises a vast array of bowel symptoms and associated quality-of-life impairment, collectively termed as low anterior resection syndrome (LARS). There are 40%-60% patients who suffer from major LARS after sphincter-preserving surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- Transanal irrigation and Best supportive therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 30 Jun 2024
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old
- Curative low anterior resection for rectal cancer with diverting stoma
- Stoma closure within 1 month
- Preoperative radiotherapy or height of anastomosis less than 5 cm from anal verge
- No evidence of anastomotic leakage or severe stenosis
Who cannot join
- Tumor recurrence or distant metastasis
- Secondary operation with stoma
- Prior disease impairing bowel function except for rectal cancer
- Any contraindication for transanal irrigation
- Pregnant or nursing
- Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease
- Cognitive or psychological disorder
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Qiyuan Qin, M.D., 86-20-38254052, qinqy3@mail.sysu.edu.cn
About this study
Official title: A Prospective, Randomized, Open, Parallel Trial of Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome in Rectal Cancer Patients
Bowel dysfunction after rectal cancer resection comprises a vast array of bowel symptoms and associated quality-of-life impairment, collectively termed as low anterior resection syndrome (LARS). There are 40%-60% patients who suffer from major LARS after sphincter-preserving surgery. No consensus exists for LARS treatment or prevention. Transanal irrigation (TAI) was reported to play a helpful role in the management of major LARS and fecal incontinence. However, the preventive effect and daily accessibility need further confirmation. In this randomized trial, TAI compared with best support treatment, is used in patients who received curative low anterior resection for rectal cancer with diverting stoma, after completion of the stoma reversal. The primary outcome is the occurrence of major LARS after 6 months of the treatment.
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- Transanal irrigation, Best supportive therapy
- Keywords
- Low Anterior Resection Syndrome, Transanal irrigation, Rectal cancer, Prevention
- 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.
Transanal irrigationProcedure or surgery
Transanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months.
Best supportive therapyOther
Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.
| Study group | Role | What they receive |
|---|---|---|
| Transanal irrigation | Experimental | Transanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months. Receives: Procedure: Transanal irrigation |
| Best supportive therapy | Active comparator | Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication. Receives: Other: Best supportive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with major low anterior resection syndrome score (LARS score)
Measured: at the time of 6 months since the start of treatment
Secondary outcomes (4)
Quality of life impairment assessed by Short Form 36 (SF-36)
Quality of life will be assessed by Short Form 36 (SF-36) health questionnaire.
Measured: at the time of 6, 12 months since the start of treatment
Number of participants with major low anterior resection syndrome score (LARS score)
Measured: at the time of 1, 3, 12 months since the start of treatment
Bowel function impairment
Bowel function will be assessed by Memorial Sloan Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI). Stool frequency will be recorded in the day and night.
Measured: at the time of 6, 12 months since the start of treatment
Fecal continence impairment
Fecal incontinence will be assessed by Wexner incontinence scale.
Measured: at the time of 6, 12 months since the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiyuan Qin, M.D., Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758195
- Sponsor's protocol ID
- E2021004
- Acronym
- TAILARS
- Status last verified
- Jun 2023
- First submitted
- 15 Feb 2021
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open, Parallel Trial of Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome in Rectal Cancer Patients
- ClinicalTrials.gov ID
- NCT04758195
- Acronym / sponsor ID
- TAILARS / E2021004
- Conditions
- Low Anterior Resection Syndrome
- Keywords
- Low Anterior Resection Syndrome, Transanal irrigation, Rectal cancer, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 Feb 2021 (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.
Bowel dysfunction after rectal cancer resection comprises a vast array of bowel symptoms and associated quality-of-life impairment, collectively termed as low anterior resection syndrome (LARS). There are 40%-60% patients who suffer from major LARS after sphincter-preserving surgery. No consensus exists for LARS treatment or prevention. Transanal irrigation (TAI) was reported to play a helpful role in the management of major LARS and fecal incontinence. However, the preventive effect and daily accessibility need further confirmation. In this randomized trial, TAI compared with best support treatment, is used in patients who received curative low anterior resection for rectal cancer with diverting stoma, after completion of the stoma reversal. The primary outcome is the occurrence of major LARS after 6 months of the treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transanal irrigation | Experimental | Procedure: Transanal irrigationTransanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months. |
| Best supportive therapy | Active comparator | Other: Best supportive therapyBest supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-75 years old
- Curative low anterior resection for rectal cancer with diverting stoma
- Stoma closure within 1 month
- Preoperative radiotherapy or height of anastomosis less than 5 cm from anal verge
- No evidence of anastomotic leakage or severe stenosis
Key exclusion criteria (7 listed)
- Tumor recurrence or distant metastasis
- Secondary operation with stoma
- Prior disease impairing bowel function except for rectal cancer
- Any contraindication for transanal irrigation
- Pregnant or nursing
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 |
|---|---|---|
| Transanal irrigationTransanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months. | Procedure or surgery | Transanal irrigation |
| Best supportive therapyBest supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication. | Other | Best supportive therapy |
Primary outcome
Number of participants with major low anterior resection syndrome score (LARS score)
Time frame: at the time of 6 months since the start of treatment
4 secondary outcomes
Quality of life impairment assessed by Short Form 36 (SF-36)
Time frame: at the time of 6, 12 months since the start of treatment
Number of participants with major low anterior resection syndrome score (LARS score)
Time frame: at the time of 1, 3, 12 months since the start of treatment
Bowel function impairment
Time frame: at the time of 6, 12 months since the start of treatment
Fecal continence impairment
Time frame: at the time of 6, 12 months since the start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
Related trials for Low Anterior Resection Syndrome
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Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
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A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
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Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
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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.
Qiyuan Qin, M.D. principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal irrigation and Best supportive therapy in people with Low Anterior Resection Syndrome, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site 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 5 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Qiyuan Qin, M.D. (86-20-38254052, qinqy3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with major low anterior resection syndrome score (LARS score) (time frame: at the time of 6 months since the start of treatment). 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 29 Jun 2023.