Active not recruitingNAINTERVENTIONAL

Transanal Irrigation for the Management of LARS

This study investigates a bowel management technique called Transanal Irrigation (TAI) for people who have experienced bowel problems after rectal cancer surgery, a condition known as Low Anterior Resection Syndrome (LARS). The study wants to find out if using TAI, delivered through an online platform with virtual nursing support, can improve these bowel symptoms and overall quality of life. Even though TAI has shown promise for LARS patients, its use in North America isn't as common. This trial is the first of its kind in North America to use an online method for teaching and supporting TAI. The goal is that the results will help more people with LARS benefit from TAI as a standard treatment option.

At a glance

Status

Active not recruiting

Phase

Sponsor

Jewish General Hospital

Enrolment target

Start

15 Jan 2022

Estimated completion

30 Jun 2026

Low Anterior Resection Syndrome Rectal Cancer

What is this study about?

If you've had surgery for rectal cancer, you might experience a group of bowel problems known as Low Anterior Resection Syndrome, or LARS. These can include needing to go to the toilet urgently, more frequently, or having trouble controlling your bowels. These issues can really affect your daily life and how you feel.

Doctors often suggest changes to your diet, fibre supplements, special medicines, or physiotherapy to help manage LARS. However, for some people, these steps aren't enough to fully control their symptoms. This study is looking at a different method called Transanal Irrigation (TAI). TAI involves gently flushing out the lower part of the bowel with water, which can help to empty it in a more controlled way. While TAI has been used successfully in Europe to help LARS symptoms and improve quality of life, it's not as widely used or understood in North America.

This study will teach people how to use TAI through an easy-to-use online platform. You'll also get support from nurses virtually, meaning you can talk to them online or over the phone. The main aim is to see if this online approach to teaching and supporting TAI can make a real difference to your LARS symptoms and your overall well-being. We hope the results will help doctors offer TAI more readily to patients who could benefit.

Key takeaways

This study evaluates Transanal Irrigation (TAI) for bowel problems after rectal cancer surgery (LARS).
TAI will be taught and supported online by nurses.
The goal is to improve bowel symptoms and quality of life.
It's the first large North American study using an online approach for TAI in LARS.
Participants must have specific LARS symptoms and internet access.

Who may be eligible?

This study is looking for adults aged 18 or older who have had specific surgery for rectal cancer. To be suitable for this study, you must have undergone a type of surgery called a low anterior resection for rectal cancer. If an ileostomy (a temporary bag) was created during your surgery, it must have been closed at least six months ago.

Importantly, your bowel symptoms, specifically your LARS score, need to be above a certain level (more than 20 points) to show that you are experiencing notable bowel problems. You must also be able to understand English or French and have access to the internet, as the study involves online learning and support.

You won't be able to join if you currently have an ostomy (a permanent bag), are receiving active treatment for rectal disease, have certain complications from your surgery like a narrowing or infection, or are already using TAI under medical guidance. The aim is to help those who aren't currently managing their LARS well.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had a 'low anterior resection' surgery for rectal cancer?
If you had a temporary ileostomy, was it closed at least 6 months ago?
Are you currently experiencing significant bowel problems (LARS) after your surgery?
Do you have reliable internet access?
Are you able to speak and understand English or French well enough for online training?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly put into one of two groups. One group will learn and use Transanal Irrigation (TAI) for six months, while the other group will continue with their usual care for LARS. If you're in the TAI group, you’ll be asked to use TAI every 1-2 days for six months. You'll learn how to do this through virtual (online) sessions with a research nurse and by using an online app, which includes videos and information.

Throughout the study, both groups will fill out questionnaires about their bowel symptoms and quality of life at different times. These assessments will help the researchers understand how well TAI is working compared to usual care. The total duration of active participation is six months, but there may be follow-up checks after this period.

Potential risks and benefits

Participating in this study might offer you the benefit of learning a new technique (Transanal Irrigation) that could significantly improve your bowel symptoms and overall quality of life if you are in the TAI group. Even if you're in the usual care group, your experiences will help us understand LARS better. Potential risks associated with TAI are generally low but can include mild discomfort or, rarely, an increased risk of bowel perforation, which the nurses will discuss in detail during training. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

Providence Hospital - St. Paul's Hospital
Verified postcode
Vancouver, Canada
University of British Columbia - Island Health Colorectal Surgery
Verified postcode
Victoria, Canada
Health Science North
Verified postcode
Greater Sudbury, Canada
London Health Science Centre
Verified postcode
London, Canada
University Health Network
Verified postcode
Toronto, Canada
Jewish General Hospital
Verified postcode
Montreal, Canada
McGill University Health Centre
Verified postcode
Montreal, Canada
Centre de Recherche du CHU de Québec - Hôpital Saint-François d'Assise
Verified postcode
Québec, Canada

Common questions

What is Low Anterior Resection Syndrome (LARS)?

LARS is a collection of bowel problems, such as needing to go urgently or more often, that can happen after surgery for rectal cancer.

What is Transanal Irrigation (TAI)?

TAI is a method where you gently flush your lower bowel with water to help empty it in a controlled way.

How will I learn how to use TAI?

You'll learn through online sessions with a research nurse and by using a special website with videos and information.

Do I need to have internet access to join?

Yes, you need to have internet access because all the learning and support for TAI will be delivered online.

Can I stop participating if I want to?

Yes, you can leave the study at any time, and it won't affect your medical care.