Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Bony Union
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Virtual Surgical Planning (VSP)
The trial research engineer (RE), located at Vancouver General Hospital (VGH), will segment the CT data to create a 3D model for surgical planning. During the teleconference between site surgeon (SS) and RE, the RE will load the CT data and the segmented 3D model into the virtual planning environment. With the RE navigating the software, which was created in-house at VGH and used in a previous case series, the SS will determine the extent of disease and define the resection planes. After the cutting planes are created, the RE will use the software to create the reconstruction plan with either the patient-specific fibula or scapula. Once the surgeon is satisfied with the plan, the teleconference will end and the RE will create and 3D print the surgical guides for the mandible, for the fibula or scapula, as well as the 3D computed reconstruction.
干预措施: Virtual Surgical Planning (VSP) (Procedure)
Free-Hand Surgery (FHS)
In FHS, the site surgeon will proceed with the surgery as per their routine practice.
干预措施: Free-Hand Surgery (Procedure)
结局指标
主要结局
Bony Union
时间窗: 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.
次要结局
- 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))
研究者
Eitan Prisman
Clinical Associate Professor
University of British Columbia