Transanal Irrigation for Anterior Resection Syndrome

Overseen By Marylise Boutros, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Ongoing chemotherapy, Radiotherapy, Others

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

Compensation: Varies

Number of Visits: 1

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transanal irrigation (TAI), a method to manage bowel movements, can improve quality of life for individuals with low anterior resection syndrome (LARS) after bowel surgery. The study examines if TAI aids in bowel control and reduces urgent bathroom trips within the first year post-surgery. Participants include patients who have undergone specific bowel surgery and are preparing for an ileostomy closure within 12 months. As an unphased study, this trial provides patients the chance to contribute to research that may enhance post-surgical recovery and quality of life.

Do I need to stop my current medications for the trial?

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

What prior data suggests that transanal irrigation is safe for patients with low anterior resection syndrome?

Research has shown that transanal irrigation (TAI) is generally easy for patients to use. Studies have found that TAI can help people with low anterior resection syndrome (LARS) feel better over the long term. In these studies, patients reported high satisfaction and experienced significant symptom relief for several years. This suggests that TAI is safe and might improve quality of life by making bowel movements more predictable and reducing urgency. Although large clinical trials are not yet available, current evidence supports its safety and effectiveness for managing LARS symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transanal irrigation (TAI) for anterior resection syndrome because it offers a new approach that goes beyond the usual conservative management options. Unlike standard treatments that often involve dietary changes, medications, and pelvic floor exercises, TAI uses a specialized irrigation kit to directly flush out the lower bowel. This method can provide more immediate and controlled relief from symptoms. Additionally, the integration of the LARS app, which supports patients in managing their condition, enhances the potential for personalized and effective treatment.

What evidence suggests that transanal irrigation is effective for anterior resection syndrome?

Research has shown that transanal irrigation (TAI), which participants in the TAI-intervention arm of this trial will receive, can greatly help people with low anterior resection syndrome (LARS). One study found that patients using TAI had much lower LARS scores upon hospital discharge, indicating significant symptom improvement. Another study identified TAI as one of the most effective treatments for severe LARS, with noticeable short-term improvements. Patients have reported better control over bowel movements and an improved quality of life. Overall, TAI appears to be a promising method for managing bowel function after surgery. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone surgery for colorectal cancer and are experiencing early Low Anterior Resection Syndrome (LARS), which affects bowel control. Participants should be in the 1-12 months post-operative period.

Inclusion Criteria

I am an adult who had surgery for rectal issues with a temporary ileostomy.

My surgery connection has healed, confirmed by specific tests.

I am scheduled for an operation to close my ileostomy.

Exclusion Criteria

Patients with inability to comprehend English or Spanish or provide informed consent

I am currently undergoing chemotherapy or radiotherapy.

I am experiencing complications from a 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 receive Transanal Irrigation (TAI) or continue with conservative management for LARS

3 months

Regular follow-ups as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Outcome assessments at 1, 2, and 3 months post-randomization

What Are the Treatments Tested in This Trial?

Interventions

• Transanal Irrigation

Trial Overview

The study tests a Transanal Irrigation (TAI) kit called Peristeen Plus, alongside a LARS mobile application, to see if they can improve bowel function and quality of life after colorectal surgery.

How Is the Trial Designed?

Group I: Transanal Irrigation (TAI) - intervention arm Experimental Treatment 2 Interventions

Participants in the TAI-intervention arm will receive TAI (using Peristeen Plus Irrigation kit), training of TAI administration, and access to the LARS app (including TAI module).

Group II: Continued conservative management - control arm. Experimental Treatment 1 Intervention

Participants in the control arm will receive conservative management and access to the LARS app (excluding the TAI module). Conservative management includes individualized combinations of dietary modifications, pharmacologic therapies, pelvic floor rehabilitation, and structured follow-up

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12379037/

Effectiveness of transanal irrigation in low anterior ...

Overall, the LARS score at discharge was significantly lower among patients who underwent irrigation (mean 34.57 vs. 12.48, p = 0.0000000038).

2.

sciencedirect.com

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

Evaluating transanal irrigation for alleviating symptoms of ...

Transanal irrigation may offer short-term relief from low anterior resection syndrome symptoms after rectal cancer surgery, although its effects may diminish ...

3.

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 ...

4.

bmcgastroenterol.biomedcentral.com

bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-03633-4

The patient perspective on transanal irrigation treatment for ...

Treatment with TAI showed the potential to improve the quality of life of patients with major LARS. The improvements in their general well-being ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12145294/

Transanal irrigation is the most effective treatment for major ...

Furthermore, the study has shown a convincing improvement in short-term outcomes (LARS score at 3 months of 9/42 in the TAI group versus 31/42 ...

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.

7.

frontiersin.org

frontiersin.org/journals/surgery/articles/10.3389/fsurg.2024.1384815/full

Is transanal irrigation the best treatment possibility for low ...

So far, there are no randomized clinical trials regarding the most effective treatment for LARS. Our aim is to evaluate whether transanal ...