Transanal Irrigation for LARS

(TAI-LARS Trial)

Not currently recruiting at 2 trial locations

Overseen By Jessica Holland, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jewish General Hospital

Disqualifiers: Ostomy, Anastomotic complications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how Transanal Irrigation (TAI), a daily procedure for aiding bowel movements, can enhance life for individuals who have undergone rectal cancer surgery and experience LARS (bowel issues post-surgery). Participants will learn TAI through an online platform with virtual nursing support to assess its effectiveness in North America. The trial includes two groups: one using TAI and the other continuing their usual care. Suitable candidates have had rectal cancer surgery, completed treatment over six months ago, and experience significant daily bowel problems. As an unphased trial, this study offers participants the opportunity to explore a potentially life-improving method with personalized support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Transanal Irrigation is safe for patients with LARS?

Studies have shown that transanal irrigation (TAI) can help people with low anterior resection syndrome (LARS) by reducing symptoms and improving quality of life. Research indicates that TAI works well over the long term, with patients experiencing significant relief and high satisfaction even after five years.

TAI is generally easy to tolerate, with many patients using it without major problems. While some studies highlight its benefits, others suggest the evidence isn't entirely convincing. This indicates that while TAI looks promising, more research is needed to confirm its true effectiveness.

Overall, TAI seems to offer benefits with manageable safety. However, like any treatment, individual reactions may vary, so discussing personal health needs with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transanal irrigation (TAI) for managing Low Anterior Resection Syndrome (LARS) because it offers a new approach compared to standard treatments like dietary modifications and medications. TAI is unique in that it directly cleanses the bowel using water, which can provide more immediate relief from symptoms like fecal incontinence and constipation. This method empowers patients to have more control over their bowel management, potentially improving their quality of life significantly and reducing reliance on medications.

What evidence suggests that Transanal Irrigation is effective for LARS?

This trial will compare the effectiveness of transanal irrigation (TAI) with traditional care for managing low anterior resection syndrome (LARS). Research has shown that TAI can greatly help people with LARS. Studies have found that patients using TAI have better control over gas and bowel movements compared to those who don't use it. Another study found that TAI lowered LARS scores, effectively reducing symptoms. Patients reported feeling more satisfied and experiencing a better quality of life with TAI as a long-term treatment. These findings suggest that TAI is a promising option for managing LARS symptoms. ^{5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Canadian rectal cancer survivors who have completed treatment at least 6 months ago, including ileostomy closure if applicable. They should be experiencing low anterior resection symptoms (LARS) with a score over 20 points and must be able to give informed consent in English or French and access the internet.

Inclusion Criteria

I had surgery for rectal cancer or advanced adenoma using a specific technique.

My ileostomy has been closed.

I finished my treatment, including any surgery to close an ileostomy, over 6 months ago.

Exclusion Criteria

I am not currently receiving any treatments.

Inability to provide informed consent, including fluency in English or French language

I have complications from a previous surgical connection between two parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention arm perform Transanal Irrigation (TAI) every 1-2 days for six months, with virtual nursing support and educational materials provided through the eLARS platform.

6 months

Virtual sessions with research nurse

Control

Participants in the control arm continue with traditional care, including dietary modifications and medications, without changes to their current management routine.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of quality of life and bowel function.

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Transanal Irrigation

Trial Overview

The study tests Transanal Irrigation (TAI) taught via an online platform with virtual nursing support to improve quality of life and alleviate LARS in patients. It's a randomized control trial aiming to establish TAI as a standard option for managing LARS symptoms in North America.

How Is the Trial Designed?

Group I: Transanal Irrigation Experimental Treatment 1 Intervention

This group will be instructed on the use of TAI to be perform daily for the three month duration of their treatment arm

Group II: Tradition care Control arm Active Control 1 Intervention

This group tradition care group will have no modification to the care they have received prior to commencing the study. The patients in this group will use the usual dietary modifications and medications prescribed by the treating team to manage their LARS. No changes will be made to the treatment regime prescribed by their surgeon.

Transanal Irrigation is already approved in European Union, Canada for the following indications:

Approved in European Union as Transanal Irrigation for:

• Low Anterior Resection Syndrome (LARS)

Approved in Canada as Transanal Irrigation for:

• Low Anterior Resection Syndrome (LARS)

Who Is Running the Clinical Trial?

Jewish General Hospital

Lead Sponsor

Trials

144

Recruited

283,000+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+

CHU de Quebec-Universite Laval

Collaborator

Trials

177

Recruited

110,000+

Published Research Related to This Trial

A retrospective audit of 15 patients using transanal irrigation (TAI) for managing low anterior resection syndrome (LARS) indicated that TAI significantly reduced the frequency of bowel movements and episodes of fecal incontinence.

Patients who used higher volumes of water with TAI experienced greater improvements, suggesting that further research into the optimal water volume for TAI could enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using transanal irrigation in the management of low anterior resection syndrome: a service audit. Embleton, R., Henderson, M.[2021]

Transanal irrigation (TAI) significantly improved bowel function in patients with low anterior resection syndrome (LARS), with a notable reduction in LARS scores and fecal incontinence scores after 12 months compared to conservative treatment.

Patients receiving TAI also reported a better quality of life, scoring higher on multiple aspects of the EORTC QLQ-C30 questionnaire, indicating that TAI not only alleviates symptoms but also enhances overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Clinical Trial of Transanal Irrigation Versus Conservative Treatment in Patients With Low Anterior Resection Syndrome After Rectal Cancer Surgery. Pieniowski, EHA., Bergström, CM., Nordenvall, CAM., et al.[2023]

Transanal irrigation (TAI) significantly reduced the number of daily and nightly defaecations in patients with anterior resection syndrome (ARS), improving their bowel control and quality of life.

After a median follow-up of 29 months, patients experienced a marked improvement in continence scores and overall quality of life, as measured by the Cleveland Incontinence Score and SF-36 questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transanal irrigation improves quality of life in patients with low anterior resection syndrome. Rosen, H., Robert-Yap, J., Tentschert, G., et al.[2011]

In a study of 37 patients who underwent ultralow rectal resection, those who received transanal irrigation (TAI) as a preventive treatment experienced significantly fewer bowel movements both during the day and night compared to the control group after 1 and 3 months.

Patients using TAI also reported better outcomes on the LARS and Wexner scores, indicating improved bowel function and quality of life, demonstrating TAI's efficacy in managing low anterior resection syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of prophylactic transanal irrigation versus supportive therapy to prevent symptoms of low anterior resection syndrome after rectal resection. Rosen, HR., Kneist, W., Fürst, A., et al.[2020]

Transanal irrigation (TAI) significantly reduced the median daily bowel movements and improved LARS scores in patients with low anterior resection syndrome, demonstrating its efficacy as a treatment option.

The study involved 33 patients, with 27 completing the treatment, and showed that TAI improved quality of life and continence, with 85% of participants wanting to continue the treatment after the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of transanal irrigation in the treatment of anterior resection syndrome. Martellucci, J., Sturiale, A., Bergamini, C., et al.[2019]

In a study of 114 patients with constipation and/or faecal incontinence, high-volume transanal irrigation (TAI) led to significant improvements in quality of life, although it did not reduce constipation symptoms for those who continued treatment for 52 weeks.

Among patients with faecal incontinence, 55.6% experienced symptom reduction, indicating that TAI may be particularly effective for this condition, while overall continuation rates for TAI were low, with only 36% of patients still using it after a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective cohort study of high-volume transanal irrigation in patients with constipation and/or faecal incontinence. Vollebregt, PF., Dekker, L., Han-Geurts, IJM., et al.[2023]

Citations

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The aim of this prospective study was to evaluate the effectiveness of TAI in reducing LARS score post anterior resection surgery. Methods.

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The patient perspective on transanal irrigation treatment for ...

The aim of the study was to explore long-term experiences of transanal irrigation (TAI) in patients with major low anterior resection syndrome (LARS).

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pubmed.ncbi.nlm.nih.gov

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Transanal irrigation is effective for low anterior resection ...

The TAI group demonstrated significantly better outcomes across all five LARS subscales compared to controls, including flatus incontinence ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1590865825008989

Transanal irrigation in patients affected by low anterior ...

Alimentary Tract. Transanal irrigation in patients affected by low anterior resection syndrome (LARS): Long-term results from an Italian national study.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12356752/

Transanal irrigation is effective for low anterior resection ...

Our pooled analysis shows that TAI is associated with significant improvements across multiple validated outcome measures, including reduced ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40826198/

Long-term outcomes of transanal irrigation in patients with ...

TAI demonstrates sustained benefits in LARS patients over 5 years, with significant symptom improvement and high patient satisfaction.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07219745

Transanal Irrigation for the Management of Early Low ...

Transanal irrigation (TAI) has shown to improve fecal incontinence and increase quality of life in patients with low anterior resection ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0039606025003848

Evaluating transanal irrigation for alleviating symptoms of ...

Although transanal irrigation holds promise against low anterior resection syndrome, existing evidence is inconclusive. In this study, we evaluated the efficacy ...