Evidence map›Paper›PMID 40016641›Full record

ArticleBMC cancer2025

A multi-centre, participant-blinded, randomized, 3-year study to compare the efficacy of Virtual Surgical Planning (VSP) to Freehand Surgery (FHS) on bony union and quality of life outcomes for mandibular reconstruction with fibular and scapular free flaps: study protocol for a randomized phase II/III trial.

Khanh Linh Tran, Sena Turkdogan, Anat Bahat Dinur, Thomas D Milner, Edward Wang, Anthony Nichols, Danielle MacNeil, Adrian Mendez, Jake Jervis-Bardy, John De Almeida and 22 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05429099 (Virtual Preplanning of Mandibular Reconstruction), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05429099 narecruitingnot on this map

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

TypeinterventionalSponsorUniversity of British ColumbiaRan2022 to 2028Enrolled420ConditionsOral Cavity Cancer, Oral CancerArmsVirtual Surgical Planning (VSP), Free-Hand Surgery
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors.

Khanh Linh TranDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Sena TurkdoganDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Anat Bahat DinurDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Thomas D MilnerDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Edward WangDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Anthony NicholsDepartment of Otolaryngology- Head and Neck Surgery, Western University, London, ON, Canada.
Danielle MacNeilDepartment of Otolaryngology- Head and Neck Surgery, Western University, London, ON, Canada.
Adrian MendezDepartment of Otolaryngology- Head and Neck Surgery, Western University, London, ON, Canada.
Jake Jervis-BardyDepartment of Otolaryngology- Head and Neck Surgery, Western University, London, ON, Canada.
John De AlmeidaDepartment of Otolaryngology- Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.
Christopher YaoDepartment of Otolaryngology- Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.
David GoldsteinDepartment of Otolaryngology- Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.
Ralph GilbertDepartment of Otolaryngology- Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.
Antoine EskanderDepartment of Otolaryngology- Head and Neck Surgery, Sunnybrook Hospital, University of Toronto, Toronto, ON, Canada.
Kevin HigginsDepartment of Otolaryngology- Head and Neck Surgery, Sunnybrook Hospital, University of Toronto, Toronto, ON, Canada.
Danny EnepekidesDepartment of Otolaryngology- Head and Neck Surgery, Sunnybrook Hospital, University of Toronto, Toronto, ON, Canada.
Michael GuptaDivision of Otolaryngology- Head and Neck Surgery, McMaster University, Hamilton, ON, Canada.
Han ZhangDivision of Otolaryngology- Head and Neck Surgery, McMaster University, Hamilton, ON, Canada.
Michael AuDivision of Otolaryngology- Head and Neck Surgery, McMaster University, Hamilton, ON, Canada.
Sally NguyenDepartment of Otolaryngology- Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.
Sidney FelsDepartment of Electrical and Computer Engineering, Faculty of Applied Science, University of British Columbia, Vancouver, BC, Canada.
Antony HodgsonDepartment of Mechancial Engineering, Faculty of Applied Science, University of British Columbia, Vancouver, BC, Canada.
Penelope BrasherCentre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada.
Craig MittonSchool of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Farahna SabiqDepartment of Radiology, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Charles FisherDepartment of Orthopaedics, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
David YangFaculty of Dentistry, University of British Columbia, Vancouver, BC, Canada.
Angela WongFaculty of Dentistry, University of British Columbia, Vancouver, BC, Canada.
Cathie GarnisDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Catherine PohFaculty of Dentistry, University of British Columbia, Vancouver, BC, Canada.
J Scott DurhamDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Eitan PrismanDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada. eitan.prisman@ubc.ca.

Funding

CIHR 163974Michael Smith Foundation for Health Research 17632Terry Fox Research Institue 1126
6 · The paper itself

Abstract

backgroundAdvanced head and neck malignancies with underlying bony involvement often require aggressive oncological resection of large segments of the oral cavity including the mandible. These patients require vascularized donor osseous free tissue transfer to reconstruct significant defects. Traditionally, the donor bone is harvested on its vascular supply and shaped to the defect in a free hand fashion (FHS). However, virtual surgical planning (VSP) has emerged as a method to optimize reconstructive outcomes and decrease operative time. The goals of this study are to assess superiority of VSP to FHS by comparing bony union rates at 12 months, short and long-term complication rates, reconstruction accuracy, quality of life (QOL), functional outcomes, and economic analysis.

methodsThis is a multicenter phase II/III study randomizing four hundred twenty head and neck patients undergoing mandibulectomy in a 1:1 ratio between VSP and FHS. Intention-to-treat analysis will be performed for patients enrolled but unable to undergo VSP-aided reconstruction. The primary endpoint is bony-union rates at 1 year post-operatively. Secondary outcomes include complication rates, QOL, functional outcomes, and economic burden. DISCUSSION: This study will provide an assessment of two different surgical approaches to the reconstructive methods of mandible defects using fibular or scapular free flaps on bony-union rates, complications, QOL and economics.

trial registrationClinicaltrials.gov identifier: NCT05429099. Date of registration: June 23, 2022. Current version: 1.0 on March 6, 2024.

Indexed as

Free Tissue FlapsHead and Neck NeoplasmsMandibular ReconstructionPlastic Surgery ProceduresQuality of LifeSurgery, Computer-AssistedAdultClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicEquivalence Trials as TopicFemaleFibulaHumansMaleMandibleMiddle AgedHead and neck cancerMandible ReconstructionOral cavityQuality of lifeRandomized controlled trialVirtual Surgical Planning

Identifiers

PMID40016641
PMCPMC11866805

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.