RecruitingNAINTERVENTIONAL

Mandibular Reconstruction Preplanning (ViPMR)

This study, called 'Mandibular Reconstruction Preplanning' (ViPMR), is looking at how best to rebuild the jaw bone after surgery for oral cancer. When cancer spreads from the mouth to the jaw, part of the jaw might need to be removed. Traditionally, surgeons reshape the jaw by hand during the operation. This study will compare that traditional method with a newer technique called Virtual Surgical Planning (VSP). VSP uses 3D computer models and 3D printing to create special guides that help surgeons rebuild the jaw very precisely. Researchers want to find out if VSP leads to a better recovery, fewer complications, and a better quality of life for patients. They will also look at the costs involved.

At a glance

Status

Recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

420

Start

15 Oct 2022

Estimated completion

15 Oct 2028

Oral Cavity Cancer Oral Cancer

What is this study about?

When someone has oral cancer, sometimes the cancer can spread into the jawbone. If this happens, a surgeon needs to remove the affected part of the jaw. After removing the bone, the jaw needs to be rebuilt, often using bone taken from another part of the body, like the leg (fibula) or shoulder blade (scapula). This rebuilding process is very important for how a person eats, speaks, and looks after surgery.

There are generally two ways surgeons rebuild the jaw. The traditional method, called 'Free-Hand Surgery,' involves the surgeon carefully shaping the new bone during the operation itself. The other method, called 'Virtual Surgical Planning' (VSP), uses modern technology. Before the surgery, doctors create a detailed 3D computer model of the patient's jaw and plan the reconstruction. They then use 3D printing to make custom guides that help the surgeon place and shape the new bone very accurately during the operation.

This study wants to find out if using VSP leads to better results for patients compared to the traditional free-hand method. Researchers will compare how well the new bone heals (called 'bony union'), whether there are fewer problems or complications, how accurate the new jaw reconstruction is, and what impact it has on a patient's daily life and overall well-being. They will also look at the economic costs of using VSP.

Key takeaways

This study compares two jaw reconstruction methods for oral cancer patients.
One method uses advanced 3D planning (VSP); the other is the standard 'free-hand' surgery.
The goal is to see which method leads to better healing, fewer complications, and improved quality of life.
You would be randomly assigned to one of the two treatment groups.
Your jaw healing will be checked 12 months after surgery using a CT scan.
Your participation could help improve future jaw reconstruction surgeries.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and have been diagnosed with oral cancer that requires removing part of your jaw and rebuilding it using bone from your leg or shoulder blade. You also need to be able to understand the study information and give your permission to take part.

There are some reasons why you wouldn't be able to join. These include having serious unrelated health problems, cancer that has spread widely in your body, or if you've been treated for head or neck cancer or had radiation in that area in the last five years. You also can't join if you are pregnant or breastfeeding, or if you don't have a recent CT scan of your head and are unable or unwilling to get one shortly before surgery.

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 have oral cancer that requires jaw removal and reconstruction?
Can you understand information about the study and give your permission to join?
Have you not had a recent head or neck cancer, or radiation to that area, in the last 5 years?
Are you not pregnant or breastfeeding?
Do you have a recent CT scan, or can you get one if needed before surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups: either you will have your jaw rebuilt using the standard 'free-hand' method, or using the newer 'Virtual Surgical Planning' (VSP) method. It's like flipping a coin to decide which group you're in, so each method has an equal chance.

After your surgery, doctors will regularly check your recovery. About 12 months after your operation, you will have a CT scan to see how well your new jawbone has healed. Throughout the study, you'll also be asked to answer questions about your quality of life, how well you can eat and speak, and if you've had any complications. The exact number of visits or length of follow-up beyond the 12-month CT scan is not detailed, but routine post-operative checks would be expected.

Potential risks and benefits

Participating in this study might mean you receive the newer Virtual Surgical Planning (VSP) method, which some research suggests could lead to more precise surgery and potentially better outcomes. However, there's also a chance you'd receive the standard free-hand surgery, which is already a proven and effective method. As with any surgery, there are potential risks regardless of the method, including infection, pain, and healing problems. The study aims to understand these risks better for both approaches. Your participation will help future patients by providing valuable information about the best way to perform these complex operations. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is 'oral cavity cancer'?

Oral cavity cancer, often called oral cancer, is cancer that starts in any part of your mouth, such as your lips, tongue, gums, or lining of your cheeks.

What is 'mandibular reconstruction'?

Mandibular reconstruction is surgery to rebuild your jawbone, usually after part of it has been removed due to cancer. Often, bone from another part of your body is used to do this.

What is the difference between the two surgical methods?

One method, 'Free-Hand Surgery,' means the surgeon shapes the new jawbone during the operation. The other, 'Virtual Surgical Planning,' uses 3D computer models and printed guides to plan and perform the surgery more precisely beforehand.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of the two groups, like drawing a name from a hat. You won't get to choose, and the researchers will compare the results of both groups.

How long will I be followed up after surgery?

The study specifically mentions comparing jaw healing at 12 months after your surgery using a CT scan, but you would have regular post-operative checks as part of your normal care in the meantime.

How to find out more

Eitan Prisman, MD, FRCSC

eitan.prisman@ubc.ca 6048754126 Official trial record

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