Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Oral Cavity Cancer
- Sponsor
- University of British Columbia
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- Bony Union
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Investigators
Eitan Prisman
Clinical Associate Professor
University of British Columbia
Eligibility 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
Outcomes
Primary Outcomes
Bony Union
Time Frame: Assessed on CT scans 12 months postoperatively
The primary outcome is nonunion as assessed by two independent radiologists at Vancouver General Hospital, blinded to the intervention, based on the 12-month postoperative CT scan. Each apposition (between native bone-flap or between flap segments) will be assessed as nonunion, partial union, and complete union. Cases where there is disagreement between reviewers will undergo consensus review, any persisting disagreements will be reviewed by a third radiologist and classification will be based on the majority vote.
Secondary Outcomes
- Oral Health(Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total))
- Economic analysis(Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total))
- Dental Implantability(Up to 100 days after the post-operative CT scan.)
- Length of Stay(From date of patient's preoperative hospital admission until the date of hospital discharge postoperatively or date of death from any cause, whichever came first, assessed up to 100 days)
- Rate of Cancer Reoccurrence(Patients will be monitored for 1 year post-operatively)
- EQ-5D-5L Survey(Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total))
- Dysphagia(Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total))
- Fibula harvest site complications(Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total))
- Difference in Intracondylar Distance(Assessed between preoperative CT (at least 6 days prior to surgery) and postoperative CT (5 days after date of surgery) scans)
- University of Washington Quality of Life (UWQoL)(Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total))
- Ischaemic Time(Initial Surgery)
- Scapula harvest site complications(Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total))
- Operative Time(Initial Surgery)
- Rate of Plate Extrusion(Patients will be monitored for 1 year post-operatively)
- Difference in Mandibular Angles(Assessed between preoperative CT (at least 6 days prior to surgery) and postoperative CT (5 days after date of surgery) scans)
- Occlusal force (bite force)(Measure documented at time of baseline clinic visit and at 1, 6, and 12 months post-surgery (4 visits total))
- Rate of Flap Failure(Patients will be monitored for 1 year post-operatively)
- Adverse Events(Charts and interviews reviewed at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total))
- Occlusion(Measure documented at time of baseline clinic visit and at 1, 6, and 12 months post-surgery (4 visits total))
- Jaw Mobility(Measure documented at time of baseline clinic visit and at 1, 6, and 12 months post-surgery (4 visits total))