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,
Christopher Yao,
David Goldstein,
Ralph Gilbert,
Antoine Eskander,
Kevin Higgins,
Danny Enepekides,
Michael Gupta,
Han Zhang,
Michael Au,
Sally Nguyen,
Sidney Fels,
Antony Hodgson,
Penelope Brasher,
Craig Mitton,
Farahna Sabiq,
Charles Fisher,
David Yang,
Angela Wong,
Cathie Garnis,
Catherine Poh,
J. Scott Durham,
Eitan Prisman
Affiliations
Khanh Linh Tran
Division of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia
Sena Turkdogan
Division of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia
Anat Bahat Dinur
Division of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia
Thomas D. Milner
Division of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia
Edward Wang
Division of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia
Anthony Nichols
Department of Otolaryngology– Head and Neck Surgery, Western University
Danielle MacNeil
Department of Otolaryngology– Head and Neck Surgery, Western University
Adrian Mendez
Department of Otolaryngology– Head and Neck Surgery, Western University
Jake Jervis-Bardy
Department of Otolaryngology– Head and Neck Surgery, Western University
John De Almeida
Department of Otolaryngology– Head and Neck Surgery, University Health Network, University of Toronto
Christopher Yao
Department of Otolaryngology– Head and Neck Surgery, University Health Network, University of Toronto
David Goldstein
Department of Otolaryngology– Head and Neck Surgery, University Health Network, University of Toronto
Ralph Gilbert
Department of Otolaryngology– Head and Neck Surgery, University Health Network, University of Toronto
Antoine Eskander
Department of Otolaryngology– Head and Neck Surgery, Sunnybrook Hospital, University of Toronto
Kevin Higgins
Department of Otolaryngology– Head and Neck Surgery, Sunnybrook Hospital, University of Toronto
Danny Enepekides
Department of Otolaryngology– Head and Neck Surgery, Sunnybrook Hospital, University of Toronto
Michael Gupta
Division of Otolaryngology– Head and Neck Surgery, McMaster University
Han Zhang
Division of Otolaryngology– Head and Neck Surgery, McMaster University
Michael Au
Division of Otolaryngology– Head and Neck Surgery, McMaster University
Sally Nguyen
Department of Otolaryngology– Head and Neck Surgery, University of Ottawa
Sidney Fels
Department of Electrical and Computer Engineering, Faculty of Applied Science, University of British Columbia
Antony Hodgson
Department of Mechancial Engineering, Faculty of Applied Science, University of British Columbia
Penelope Brasher
Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute
Craig Mitton
School of Population and Public Health, Faculty of Medicine, University of British Columbia
Farahna Sabiq
Department of Radiology, Faculty of Medicine, University of British Columbia
Charles Fisher
Department of Orthopaedics, Faculty of Medicine, University of British Columbia
David Yang
Faculty of Dentistry, University of British Columbia
Angela Wong
Faculty of Dentistry, University of British Columbia
Cathie Garnis
Division of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia
Catherine Poh
Faculty of Dentistry, University of British Columbia
J. Scott Durham
Division of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia
Eitan Prisman
Division of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British Columbia
Abstract Background Advanced 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. Methods This 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 registration Clinicaltrials.gov identifier: NCT05429099. Date of registration: June 23, 2022. Current version: 1.0 on March 6, 2024.
