Not yet recruitingPHASE2INTERVENTIONAL

Buccal Fat for Transoral Robotic Lateral Oropharyngectomy Defects to and Postoperative Pain

This research wants to find out if using a small piece of fat from your cheek (called buccal fat) during a specific type of robotic surgery for tonsil or mouth cancer can make a difference to how much pain you feel afterwards. The surgery, called Transoral Robotic Surgery (TORS), removes tumours in the back of the mouth and throat. Usually, the area is left to heal naturally, which can cause significant pain. Researchers will compare patients who have this fat cushion added to those who don't, to see if it lessens pain, improves swallowing, reduces complications, and decreases the need for strong painkillers and feeding tubes. The aim is to make recovery from this surgery more comfortable.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

University Health Network, Toronto

Enrolment target

Start

01 Jun 2025

Estimated completion

01 May 2027

Tonsil Neoplasm Oropharynx Neoplasm Transoral Robotic Surgery

What is this study about?

This clinical trial is looking at a new way to help people recover more comfortably after a type of keyhole surgery called Transoral Robotic Surgery (TORS). This surgery is used to remove certain cancers in the back of the mouth and throat, specifically in the tonsil area. While TORS is a great way to remove these cancers without needing big cuts on the outside of your neck, the area where the tumour was removed is usually left open to heal on its own. This can lead to a lot of pain, difficulty swallowing, and dehydration in the days after the operation.

The main idea behind this study is to see if placing a small piece of natural fat from inside your cheek – called 'buccal fat' – into the empty space left by the removed tumour can act like a cushion. We want to find out if this cushion can help reduce the pain you feel, especially when swallowing, and make your recovery smoother. Researchers will be carefully comparing how much pain patients experience, how easily they can swallow, if they have fewer complications, and if they need less strong pain medication or feeding tubes.

Currently, there isn't a lot of clear information on how different surgical choices affect pain after TORS. This study hopes to fill that gap by focusing specifically on the impact of this buccal fat cushion. By doing so, doctors hope to discover better ways to manage pain and improve the overall experience for patients undergoing this important surgery, helping them get back to normal life more quickly and comfortably.

Key takeaways

This study evaluates whether adding cheek fat during throat cancer surgery reduces post-operative pain.
It aims to improve recovery for patients undergoing Transoral Robotic Surgery (TORS) for specific throat cancers.
Pain, swallowing ability, and complications will be compared between two groups: with and without the fat cushion.
Participation could lead to more comfortable recoveries for future patients.
You will be randomly assigned to a treatment group, and neither you nor your doctor will know which one.

Who may be eligible?

This study is looking for adults aged 18 or over who need to have specific robotic surgery to remove a tumour in their tonsil area. This includes certain types of early to medium-stage tonsil cancer or specific salivary gland tumours in the tonsils. To join, you also need to understand and agree to the study process.

However, you won't be able to take part if you've had head and neck cancer or radiation treatment in that area before. Other reasons you might not be suitable include having certain swollen glands in your neck, difficulty opening your mouth fully, or if you're pregnant. Also, if you have certain psychological factors that could increase the risk of opioid dependence, or if your surgery needs a different type of complex reconstruction, you wouldn't be able to join this particular 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.

Are you 18 years old or older?
Do you need robotic surgery for tonsil cancer or specific tonsil-area tumours?
Have you NOT had head and neck cancer or radiation treatment before?
Are you able to speak to doctors and give your consent?
Are you NOT pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance to one of two groups: one group will have the buccal fat cushion placed during their surgery, and the other group will have the standard surgery without it. You won't know which group you are in. After your surgery, you will be asked to rate your pain and how easy it is to swallow using a simple scale. This will happen at specific times during your recovery. Researchers will also be looking at how many painkillers you use, if you need a feeding tube, and any complications you might have. The exact duration of your participation will be linked to your recovery period, likely during your hospital stay and for a short time after you go home, but specific follow-up visits beyond standard care will be minimal.

Potential risks and benefits

Taking part in this study might offer the benefit of potentially less pain and an easier recovery after your surgery, especially if you are in the group that receives the buccal fat cushion. Even if you are in the standard care group, your participation helps doctors learn more which could improve future patient care. As with any surgery, there are risks, and adding the fat cushion might have its own small risks, though this is being carefully investigated. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Toronto General Hospital
Verified postcode
Toronto, Canada

Common questions

What is buccal fat?

Buccal fat is a natural pad of fat found inside your cheek. It's a small, soft cushion.

What is Transoral Robotic Surgery (TORS)?

TORS is a type of keyhole surgery that uses a robot to remove tumours from the back of your mouth and throat, avoiding large cuts on your neck.

Will I know if I'm getting the fat cushion?

No, you'll be assigned to a group by chance, and neither you nor your doctors will know which treatment you received until after the study is complete, to keep the results fair.

Will this study affect my cancer treatment?

No, the main goal is to improve recovery from the surgery that removes your cancer. Your cancer treatment will remain the priority.

What kind of pain will be measured?

Researchers will measure your pain at rest and, very importantly, when you are swallowing, using a simple rating scale.

How to find out more

Christopher Yao, MD FRCSC

christophermkl.yao@uhn.ca (416) 340-3063 Official trial record

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