Mandibular Reconstruction Preplanning (ViPMR)

Официальное название

Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial

Обзор

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.

Вмешательства

• Процедура Virtual Surgical Planning (VSP)
  The 3D reconstruction model, not requiring sterilization, will be sent directly to the SS. Prior to surgery, the SS will prebend a titanium fixation plate to the reconstruction model. Both the surgical cutting guides and titanium plate will be sterilized prior to use in surgery. If the planned resection cannot proceed (possibly due to tumour growth), the surgical team will note the reason for abandonment and conduct a standard FHS. Intraoperatively, the SS will apply the mandibular cutting guide
• Процедура Free-Hand Surgery
  The SS will adopt their standard procedure for the mandibular resection and reconstruction. This typically involves bending a titanium fixation plate, harvesting of the bony flap, and shaping of the segments all intraoperatively based on the SS's judgement.

Первичные конечные точки

• Bony Union [Срок оценки: Assessed on CT scans 12 months postoperatively]

Вторичные конечные точки (12)

• Difference in Intracondylar Distance [Срок оценки: Assessed between preoperative CT (at least 6 days prior to surgery) and postoperative CT (5 days after date of surgery) scans]
• Difference in Mandibular Angles [Срок оценки: 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) [Срок оценки: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
• EQ-5D-5L Survey [Срок оценки: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
• Dysphagia [Срок оценки: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
• Oral Health [Срок оценки: 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 [Срок оценки: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
• Scapula harvest site complications [Срок оценки: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
• Economic analysis [Срок оценки: Measure documented at time of baseline clinic visit and at 1, 3, 6, 9 and 12 months post-surgery (6 visits total)]
• Occlusal force (bite force) [Срок оценки: Measure documented at time of baseline clinic visit and at 1, 6, and 12 months post-surgery (4 visits total)]
• Dental Implantability [Срок оценки: Up to 100 days after the post-operative CT scan.]
• Operative Time [Срок оценки: Initial Surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Vancouver General Hospital — Vancouver

Публикации

• Tran KL, Turkdogan S, Dinur AB, Milner TD, Wang E, Nichols A, MacNeil D, Mendez A, Jervis-Bardy J, De Almeida J, Yao C, Goldstein D, Gilbert R, Eskander A, Higgins K, Enepekides D, Gupta M, Zhang H, Au M, Nguyen S, Fels S, Hodgson A, Brasher P, Mitton C, Sabiq F, Fisher C, Yang D, Wong A, Garnis C, Poh C, Durham JS, Prisman E. A multi-centre, participant-blinded, randomized, 3-year study to compar PMID 40016641

Идентификаторы

NCT: NCT05429099 · H20-03314

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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