Mandibular Reconstruction Preplanning (ViPMR)
Recruiting now · Not applicable
Conditions studied: Oral Cavity Cancer, Oral Cancer
In brief
Virtual Surgical Planning (VSP), where 3D modeling is used to create 3D-printed surgical guides, has been shown to improve outcomes for patients who undergo mandibular reconstruction surgery, usually due to invasion of cancer from the oral cavity to the jaw. This trial will directly compare the outcomes of patients who receive VSP versus patients who receive the current standard of care, which is Free-Hand Surgery (FHS). They will be randomized into either treatment at a 1:1 ratio and bony union rates will be compared between 12-month postoperative CT scans for each treatment group. Secondary objectives include comparing other short and long-term complication rates, reconstruction accuracy, quality of life, and functional outcomes of VSP and FHS. An economic analysis of VSP will also be performed.
Key facts
- Study ID
- NCT05429099
- Run by
- University of British Columbia
- People needed
- 420
- Starts
- 2022-10-15
- Expected to finish
- 2028-10-15
- Last updated by the study team
- 2026-06-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- primary diagnosis requiring mandibulectomy and fibular or scapular free flap reconstructive surgery
- are over the age of 18
- cognitive ability and language skills that allow participation in the trial
- provide informed consent
You may not qualify if…
- severe comorbidities including metastatic disease
- do not have a recent (within 30 days) CT scan and are unable/unwilling to receive a head CT scan at the latest 6 days prior to surgery
- prior history of head or neck cancer within last 5 years
- prior history of head or neck radiation treatment at any time
- pregnant of lactating women
Where it is running
- Vancouver General Hospital — Vancouver, British Columbia, Canada (enrolling)
Full record on ClinicalTrials.gov
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