Transanal Irrigation for LARS

(TAI-LARS Trial)

Recruiting at 1 trial location

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

66 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Transanal Irrigation for LARS?

Research shows that transanal irrigation (TAI) is effective in reducing symptoms like frequent bowel movements and faecal incontinence in patients with low anterior resection syndrome (LARS). Studies also indicate that TAI can improve the quality of life for these patients. ^{1 2 3 4 5}

How does transanal irrigation differ from other treatments for low anterior resection syndrome?

Transanal irrigation (TAI) is unique because it involves flushing the rectum with water to manage symptoms of low anterior resection syndrome (LARS), such as frequent bowel movements and fecal incontinence. Unlike other treatments, TAI is a non-drug, mechanical method that can be adjusted in volume to improve patient outcomes. ^{1 3 4 5 6}

What is the purpose of this trial?

This trial is testing if using water to flush out the bowel can help Canadian rectal cancer survivors with severe bowel symptoms. The treatment will be taught and supported online by nurses. The goal is to see if this method improves their quality of life and reduces symptoms. This method has shown promise in clinical experience but lacks extensive scientific evidence.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Role of transanal irrigation in the treatment of anterior resection syndrome. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Transanal irrigation improves quality of life in patients with low anterior resection syndrome. [2011]

3. England pubmed.ncbi.nlm.nih.gov

Using transanal irrigation in the management of low anterior resection syndrome: a service audit. [2021]

4. England 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. [2020]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Prospective cohort study of high-volume transanal irrigation in patients with constipation and/or faecal incontinence. [2023]