RecruitingNAINTERVENTIONAL

Evaluation of the Benefit of a New Surgical Procedure According to IDEAL Recommendations for ORL Cancer Patients: the External Pudendal Flap Used as a New Free Flap for Oral Cavity/Oropharyngeal Reconstruction to Limit Donor Site Sequelae

This study is testing a new surgical technique to rebuild parts of the mouth or throat (oro-pharynx) in patients who have had cancer removed. Doctors are using a new type of tissue flap from a different area of the body, aiming to limit side effects where the tissue was taken from. The study involves two main stages. The first stage focuses on making sure the new method is practical and doesn't cause too many surgical problems. The second stage will look closely at any complications that might arise. Around 40 patients will take part in these initial stages. Doctors will follow patients for 12 months after their treatment to see how they recover. There will also be a separate study with more patients to understand how acceptable this new technique is to them.

At a glance

Status

Recruiting

Phase

Sponsor

Institut Claudius Regaud

Enrolment target

Start

08 Nov 2023

Estimated completion

01 Jan 2027

Head and Neck Cancer Oral Cavity Cancer Oropharynx Cancer

What is this study about?

This research is looking into a new way to help people who have had surgery for cancer in their mouth or throat. When doctors remove cancer from these areas, they often need to rebuild the missing parts using tissue from another part of the body. This study introduces what's called an "external pudendal flap" – it's a specific type of skin and tissue taken from the groin area.

The main idea behind using this new flap is to see if it can help rebuild the mouth or throat with fewer problems for the patient, especially at the site where the tissue is taken from. The study is divided into two main parts. The first part is about making sure this new surgical method works well and doesn't lead to too many complications during or after the operation. The second part will focus on carefully tracking any complications that might happen to patients who receive this new procedure.

Ultimately, the goal is to find a safer and more effective way to help patients recover after serious cancer surgery, improving their quality of life. By understanding how well this new flap works and whether patients find it acceptable, doctors hope to offer better treatment options in the future.

Key takeaways

Tests a new surgical method for mouth/throat cancer patients.
Uses tissue from the groin to rebuild affected areas.
Aims to reduce side effects compared to current methods.
Involves careful follow-up for 12 months after treatment.
Only for specific head and neck cancers.
Patients can leave the study at any time.

Who may be eligible?

To be considered for this study, you would need to have specific types of head and neck cancer, either in your mouth or throat, that an experienced surgeon believes could benefit from this new reconstruction method. You must be at least 18 years old.

There are also some important reasons why you might not be able to join. For example, if you've already had surgery or radiation treatment to your neck or pelvis, you wouldn't be eligible. Certain health conditions like uncontrolled diabetes, severe autoimmune diseases, or specific heart conditions might also prevent you from taking part. Pregnant or breastfeeding women also cannot participate. You would also need to be able to comfortably manage the follow-up appointments and procedures required by the study.

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.

I have been diagnosed with certain head and neck cancers (oral cavity or oropharynx).
My cancer is at a specific stage (T0-4a N0/N2c M0).
A surgeon believes this new reconstruction method might help me.
I am at least 18 years old.
I do not have certain medical conditions like uncontrolled diabetes or previous radiation to my neck/pelvis.
I am able to attend all follow-up appointments required by the study.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be followed for 12 months after your surgery and any other treatments like chemotherapy or radiotherapy. During this time, doctors will closely monitor your recovery and check for any complications from the new surgical procedure. The study involves two main groups of up to 20 patients each. You would have regular check-ups to assess how you're healing and feeling. There's also a separate, larger study that will simply observe 250 patients to understand their opinions and experiences with this reconstruction technique.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new surgical technique that aims to reduce side effects compared to traditional methods. However, as with any surgery, there are always risks, including potential complications from the operation itself or issues at the site where the tissue flap is taken from. You will be closely monitored for these. It’s important to remember that joining is always your choice, and you have the right to withdraw from the study at any time without affecting your standard medical care.

Locations (4)

Chu Gui de Chauliac
Verified postcode
Montpellier, France· Not yet recruiting
Centre Antoine Lacassagne
Verified postcode
Nice, France· Recruiting
Chu Purpan
Verified postcode
Toulouse, France· Not yet recruiting
Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
Verified postcode
Toulouse, France· Recruiting

Common questions

What kind of cancer is this study for?

This study is specifically for certain head and neck cancers, located in the mouth or throat.

What is an 'external pudendal flap'?

It's a piece of skin and tissue taken from your groin area, which surgeons use to rebuild parts of your mouth or throat after cancer removal.

Will I have to pay to be in the study?

No, you must be covered by health insurance in France to be eligible, but taking part in a clinical trial itself generally doesn't incur direct costs to you for the study-related procedures.

How long will I be involved in the study?

You'll be followed for 12 months after your complete treatment (surgery plus any other therapies like chemotherapy or radiotherapy).

Can I leave the study once I've joined?

Yes, you are free to withdraw from the study at any time without any impact on your ongoing medical care.

How to find out more

Agnès DUPRET-BORIES

dupret-bories.agnes@iuct-oncopole.fr 05 31 15 53 08 Official trial record

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