RecruitingNAINTERVENTIONAL

Fistula-in-ano in Infants and Children

Doctors at a hospital are running a study to find the best way to treat a condition called fistula-in-ano in babies and children up to 18 years old. This condition involves a small tunnel near the bottom. The study uses a special, soft thread called a "seton" to help the area heal. Some children will have the seton in for 4 weeks, while others will have it in for 12 weeks. The aim is to see which length of time works better. Everyone involved will provide their agreement to take part after fully understanding what the study involves.

At a glance

Status

Recruiting

Phase

Sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Enrolment target

Start

01 Jan 2023

Estimated completion

31 Dec 2027

Fistula in Ano

What is this study about?

Imagine a small, unusual tunnel or passage that forms near the area where you pass stool. This is called a fistula-in-ano. It can sometimes cause discomfort or other problems. In babies and children, doctors often use a special, soft thread called a "seton" to help treat this condition. The seton is placed inside the tunnel to help it drain and heal properly. Think of it like a very thin, flexible string that helps keep an opening clear.

This study is trying to find out the best amount of time to leave this seton in place. Some doctors might leave it in for a shorter time, while others might keep it in for longer. So, in this study, the children will be randomly assigned to one of two groups: one group will have the seton in for 4 weeks, and the other group will have it in for 12 weeks. "Randomly assigned" means it's like flipping a coin – it's decided by chance, not by choice.

The main goal of this research is to see if one of these timeframes works better than the other in helping the fistula heal. By comparing the results from both groups, the doctors hope to learn how to provide the best treatment for children with this condition in the future. This kind of study is really important for improving healthcare for young patients.

Key takeaways

This study is for children (0-18 years) with a condition called fistula-in-ano.
It researchs the best time to leave a special thread (seton) in place for healing.
Children will be in one of two groups: seton for 4 weeks or seton for 12 weeks.
The goal is to improve future treatments for this condition.
Participation involves routine medical checks and follow-ups.

Who may be eligible?

This study is looking for babies, children, and young people up to 18 years old who have a condition called fistula-in-ano. To be considered for the study, you must be receiving treatment for this condition with a "non-cutting seton" at the hospital where the study is taking place.

It doesn't matter what other health conditions a child might have; everyone with fistula-in-ano being treated with this method at the hospital can be considered. The important thing is that the child is between birth and 18 years old.

There are no specific reasons why someone would be excluded from participating, as long as they meet the age and treatment criteria mentioned above.

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.

Is your child 18 years old or younger?
Does your child have a condition called fistula-in-ano?
Is your child being treated with a 'non-cutting seton' at the study hospital?
Are you comfortable with your child being randomly assigned to a 4-week or 12-week treatment group?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you or your child will be treated for fistula-in-ano using a non-cutting seton. Once the seton is placed during a routine medical procedure, your child will be put into one of two groups by chance: either the seton will stay in for 4 weeks, or it will stay in for 12 weeks.

During this time, you will have regular visits to the hospital or clinic. These visits will be to check on how your child is doing and how the seton is working. The doctors will monitor the healing process. After the seton is removed, there will likely be follow-up appointments to ensure everything is healing well.

This study will involve these medical steps and check-ups over the course of either 4 or 12 weeks, depending on which group your child is in, plus any necessary follow-up appointments after the seton is removed. All medical decisions will be discussed with you.

Potential risks and benefits

Taking part in this study may or may not directly benefit your child, as the main goal is to improve future treatments. However, your child will receive careful medical attention throughout the study. Potential risks are generally linked to the standard seton treatment itself, which might include discomfort, infection, or the seton coming out too early, though these are typically managed by the medical team. You are free to withdraw your child from the study at any time, for any reason, without it affecting their normal medical care.

Locations (1)

Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What is a 'fistula-in-ano'?

It's a small, unusual tunnel that can form near the bottom area, often causing discomfort or drainage.

What is a 'seton'?

It's a soft, special thread or string that doctors place in the tunnel to help it drain and heal.

Will my child feel pain with the seton?

The medical team will take steps to manage any discomfort, and they can provide more specific information about pain relief.

Why are there two different time lengths for the seton?

The study wants to find out if leaving the seton in for 4 weeks or 12 weeks works better for healing.

Can I decide not to continue in the study?

Yes, you can choose to withdraw your child from the study at any point, and their regular medical care will not be affected.

How to find out more

Sonja Diez, MD

sonja.diez@uk-erlangen.de 004991318532923 Official trial record

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