RecruitingNAINTERVENTIONAL

Rehabilitation Improved by Early Detection of Fisyulas Post (Pharyngo) -Total Laryngectomy by Cytokine Measurement on Drainage Fluid on the Second Post-Operative Day

This study is for people who have had an operation for cancer in their throat or voice box, called a laryngectomy. Sometimes, after this surgery, a small leak can happen. The study wants to find out if testing the fluid that drains from the surgery site can show early signs of good healing. If healing is going well, doctors might be able to let patients eat solid food sooner after their operation. Currently, some people wait up to 15 days, which can be difficult. Eating earlier could help people feel better, recover faster, and spend less time in the hospital. The study will compare patients who eat earlier (around 3-4 days after surgery) with those who eat later (around 7 days), to see if earlier eating is safe and helpful for those showing signs of good healing.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Clermont-Ferrand

Enrolment target

250

Start

12 Feb 2025

Estimated completion

01 May 2028

Cancer, Otorhinolaryngeal

What is this study about?

When someone has surgery for throat or voice box cancer (called a total laryngectomy or pharyngo-laryngectomy), it's a big operation. A common problem that can happen afterwards is a small leak at the surgery site, known as a fistula. This leak can slow down recovery, mean a longer hospital stay, and can be quite uncomfortable. Currently, doctors usually decide when it's safe for patients to start eating again based on general practice, which can mean waiting anywhere from 5 to 15 days.

This study hopes to improve this process. Researchers believe that by looking at special markers in the liquid that drains away from the surgery site in the first couple of days, they can tell if someone is healing well. If these markers (called cytokines, especially IL10) are low, it might mean the wound is healing neatly and there's a lower chance of a leak. If this is the case, the study wants to see if allowing patients to eat solid food earlier – around 3 or 4 days after the operation – is safe and beneficial. The main idea is that if you're healing well, you could start eating sooner without increasing your risk of problems.

By helping doctors identify who is healing well, this study aims to make recovery smoother and quicker for patients. If people can start eating earlier, they might feel better overall, get home from the hospital sooner, and improve their quality of life after such a big surgery. The study also aims to look at other benefits, such as nutritional health, the timing of any further treatments like radiotherapy, and how patients feel about their quality of life.

Key takeaways

This study aims to find a way to help people eat solid food sooner after major throat or voice box surgery.
It uses a special test on drainage fluid to check for early signs of good healing.
Eating earlier could mean a quicker recovery and getting home from hospital sooner for some patients.
The study compares early feeding (day 3-4) with later feeding (day 7).
It could improve care for future patients undergoing similar surgeries.
Participation is voluntary, and your care will not be affected if you choose not to join.

Who may be eligible?

To be considered for this study, you must be an adult who has been diagnosed with cancer that needs an operation called a total laryngectomy or pharyngo-laryngectomy. This surgery must have been planned and agreed upon by a team of specialists. You also need to be covered by a social security plan, like the NHS in the UK, to take part.

However, some people cannot join the study. This includes pregnant or breastfeeding women. Also, if you are under special care arrangements where someone else manages your affairs (like a legal guardianship), or if you are in prison, you won't be able to participate. If your body mass index (a measure of your weight compared to your height) is very low (below 18.5 kg/m2), or if the study doctors think that another health condition you have makes it unsafe for you to join, then you won't be able to take part. Finally, if you simply decide you don't want to participate, that's perfectly fine and you won't be included.

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 an adult with cancer needing a total laryngectomy or pharyngo-laryngectomy?
Do you have social security coverage (like the NHS)?
Are you not pregnant or breastfeeding?
Are you not under legal guardianship or in prison?
Is your body weight healthy and not very low?
Have your doctors said there are no other health reasons preventing you from joining?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your doctor will explain everything carefully, and you'll have time to ask questions before agreeing. The study starts from your surgery. Doctors will collect fluids that drain from your operation site on the second day after surgery. This fluid will be tested to check how well you're healing. Depending on these test results, you will either be in a group that starts eating solid food early (around day 3 or 4 after surgery) or a group that follows the usual plan (eating around day 7).

Doctors will keep a close eye on you to see if any leaks or other problems occur within 30 days of your surgery. They will also track things like how long you stay in hospital, how your nutrition is doing, how soon you might start any further cancer treatments, and your overall quality of life. The total length of your involvement in the study will depend on your hospital stay and follow-up appointments, but the main observations about healing and complications will focus on the first month after surgery.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as the chance to eat solid food earlier after your major surgery, which could help you feel better, recover faster, and get home sooner if your healing is good. It could also help improve our understanding of how to manage care for patients like you in the future. However, there are potential risks, as with any medical study. Although the study aims to identify patients who are low risk for earlier feeding, there's always a chance of complications after surgery. You will be closely monitored for any issues. It's very important to remember that participating is entirely your choice. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

CHU de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
CHU de Grenoble
Verified postcode
Grenoble, France· Not yet recruiting
CH Emile Roux
Verified postcode
Le Puy-en-Velay, France· Not yet recruiting
HCL Hôpital Croix Rousse
Verified postcode
Lyon, France· Not yet recruiting
CHU de Saint-Etienne
Verified postcode
Saint-Etienne, France· Not yet recruiting
CH de Valence
Verified postcode
Valence, France· Not yet recruiting
Institut Gustave Roussy
Verified postcode
Villejuif, France· Not yet recruiting

Common questions

What is a total laryngectomy or pharyngo-laryngectomy?

It's a major operation to remove part or all of your voice box (larynx) or throat (pharynx), usually because of cancer.

What is a 'fistula' and why is it a problem?

A fistula is a small leak that can sometimes happen at the surgery site after your operation. It can slow down your recovery and mean you stay in hospital longer.

How will the study decide if I can eat earlier?

Doctors will test fluid that drains from your surgery wound a couple of days after the operation. If the tests show good healing, you might be able to start eating solid food sooner.

Will I be safe if I eat earlier?

The study aims to make sure that only people who are healing well and have a low risk of problems will be offered earlier feeding. You will be carefully monitored.

What happens if I don't want to join the study?

That's absolutely fine. Your decision will not affect the medical care you receive, and you will be treated according to standard hospital practices.

How to find out more

Lise Laclautre

promo_interne_drci@chu-clermontferrand.fr 334.73.754.963 Official trial record

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