RecruitingNAINTERVENTIONAL

Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication

This study is investigating new designs of colostomy bags that use a special filter system. The main goal is to find out if these improved filters can help reduce inconvenient issues like the bag puffing up with gas (called 'ballooning'), or stool leaking through the filter (called 'pancaking'). It also aims to see if they can better control odours. Participants will try three different types of colostomy bags over a short period. By comparing these bags, researchers hope to identify the most effective design for improving comfort and confidence for people who use a colostomy bag. This research could lead to better products that reduce common problems experienced by people with a colostomy.

At a glance

Status

Recruiting

Phase

Sponsor

Salts Healthcare

Enrolment target

Start

29 Nov 2024

Estimated completion

30 Apr 2025

Colostomy - Stoma Colostomy Complications

What is this study about?

This study is looking into a common issue for people who have a colostomy – those clear filters on bags that are supposed to let out gas and prevent smells. Sometimes, these filters don't work as well as they should, leading to problems like the bag filling with air and bulging (called 'ballooning') or, less commonly, stool blocking or leaking through the filter (called 'pancaking'). The study wants to see if new, improved filters built into some colostomy bags can make these everyday problems happen less often, control smells better, and prevent leaks more effectively.

To do this, the study will compare three different types of colostomy bags. All the bags are 'closed bags' and are made by the same company (Confidence Be, Confidence Natural, and Confidence Be go). Each of these bags has a slightly different filter system. The researchers want to find out which type of filter works best to make life easier and more comfortable for people living with a colostomy.

The findings from this study are important because they could lead to better colostomy bags being available. If these new filter systems prove to be more effective, it could mean fewer embarrassing or uncomfortable moments, better odour control, and increased confidence for people using these bags every day. This research aims to improve the quality of life for individuals with a colostomy by tackling common bag-related challenges.

Key takeaways

The study tests new colostomy bags with special filters.
It aims to reduce problems like bag 'ballooning' and leaks.
You'll try three different bags over three weeks.
Your feedback helps improve colostomy products for others.
Participation is at home and lasts 21 days.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or over who have had a colostomy for at least six months. You should also be experiencing some problems with your current colostomy bag filter, such as 'ballooning' (the bag puffing up with gas), 'pancaking' (stool blocking or leaking through the filter), odour, or leaks, at least once a week. You should be able to look after your colostomy yourself, be using a flat, closed colostomy bag with a sticky baseplate, and your stoma (the opening) should be less than 5.5cm across. Also, you need to be able to read and complete questionnaires in English.

There are a few reasons why you might not be able to join the study. For example, if you use a method called colostomy irrigation (flushing out your colon), or if the skin around your stoma is bleeding or broken. Also, if you've had radiotherapy or chemotherapy in the last two months, are pregnant or breastfeeding, or are already taking part in another medical study, you won't be able to participate. Finally, if you're currently receiving ongoing treatment for your stoma from a specialist nurse, this study might not be suitable for you.

Quick self-check

Are you 18 or older?
Have you had a colostomy for at least 6 months?
Do you get filter-related problems (like ballooning or leaks) at least once a week?
Do you look after your colostomy yourself?
Do you use a flat, closed colostomy bag with a sticky baseplate?
Can you read and fill out forms in English?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be asked to try out three different types of colostomy bags for a short period. The study lasts for a total of 21 days, divided into three separate 7-day periods. During each of these 7-day periods, you will use one specific type of colostomy bag (let's call them Bag A, Bag B, and Bag C). You'll switch to a new type of bag for each new 7-day period.

You won't need to change your normal routine for changing your bag; you can do it as often as you usually would or whenever you feel it's necessary. The study will provide you with the bags, and you'll keep track of your experiences by filling out questionnaires. There are no special clinic visits or extra tests as part of this study beyond using the bags and recording your feedback. After the 21 days, your participation in the study will be complete.

Potential risks and benefits

A potential benefit of taking part in this study is that you might find one of the new colostomy bags with an improved filter system works better for you, reducing problems like 'ballooning' or leaks and improving odour control. Your feedback will also help create better products for everyone with a colostomy. As for risks, these are generally low as you will be using medical devices (colostomy bags) similar to what you already use. There is always a small possibility of skin irritation or other issues, though you would switch back to your usual bag if serious problems occurred. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Central Skin Sciences Institute (CSSI) Salts Healthcare
Birmingham, United Kingdom· Recruiting

Common questions

What is 'ballooning'?

Ballooning is when your colostomy bag fills with gas and bulges out, which can be uncomfortable or noticeable.

What is 'pancaking'?

Pancaking is when stool collects at the top of the bag and might block the filter or even leak through it.

Will I have to pay for the colostomy bags?

No, all the colostomy bags used during the study will be provided to you free of charge.

How long will I be in the study?

Your participation will last for a total of 21 days, divided into three separate weeks.

Do I need to visit a hospital for this study?

No, this study does not involve hospital visits. You will manage the colostomy bags and complete questionnaires at home.

How to find out more

Clinical Research Coordinator

info@cssinstitute.co.uk +44 (0) 121 333 2015 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.