Improving jaw reconstruction for oral cancer patients using virtual planning
Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial
This study is testing if using virtual planning for jaw surgery can help oral cancer patients heal better and have a better quality of life compared to traditional surgery methods.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05429099 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Virtual Surgical Planning (VSP) compared to traditional Free-Hand Surgery (FHS) for patients undergoing mandibular reconstruction due to oral cavity cancer. Participants will be randomly assigned to receive either VSP or FHS, and their outcomes will be assessed through postoperative CT scans at 12 months to compare bony union rates. Additionally, the study will analyze other complications, reconstruction accuracy, quality of life, and functional outcomes, along with an economic evaluation of VSP. The goal is to determine if VSP can improve surgical results and patient experiences.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a primary diagnosis requiring mandibulectomy and reconstructive surgery using fibular or scapular free flaps.
Not a fit: Patients with severe comorbidities, recent head or neck cancer history, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better surgical outcomes and improved quality of life for patients undergoing jaw reconstruction.
How similar studies have performed: Previous studies have shown promising results with Virtual Surgical Planning in surgical procedures, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Vancouver, British Columbia
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Eitan Prisman, MD, FRCSC
- Email: eitan.prisman@ubc.ca
- Phone: 6048754126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.