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
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 defec...
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2025-02-01
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| Online Access: | https://doi.org/10.1186/s12885-025-13505-5 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Khanh Linh Tran |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-104e8e296a834d7b9178b7fbe6035de0 |
| institution | OA Journals |
| issn | 1471-2407 |
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| publishDate | 2025-02-01 |
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| series | BMC Cancer |
| spelling | doaj-art-104e8e296a834d7b9178b7fbe6035de02025-08-20T02:01:35ZengBMCBMC Cancer1471-24072025-02-0125111010.1186/s12885-025-13505-5A 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 trialKhanh Linh Tran0Sena Turkdogan1Anat Bahat Dinur2Thomas D. Milner3Edward Wang4Anthony Nichols5Danielle MacNeil6Adrian Mendez7Jake Jervis-Bardy8John De Almeida9Christopher Yao10David Goldstein11Ralph Gilbert12Antoine Eskander13Kevin Higgins14Danny Enepekides15Michael Gupta16Han Zhang17Michael Au18Sally Nguyen19Sidney Fels20Antony Hodgson21Penelope Brasher22Craig Mitton23Farahna Sabiq24Charles Fisher25David Yang26Angela Wong27Cathie Garnis28Catherine Poh29J. Scott Durham30Eitan Prisman31Division of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British ColumbiaDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British ColumbiaDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British ColumbiaDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British ColumbiaDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British ColumbiaDepartment of Otolaryngology– Head and Neck Surgery, Western UniversityDepartment of Otolaryngology– Head and Neck Surgery, Western UniversityDepartment of Otolaryngology– Head and Neck Surgery, Western UniversityDepartment of Otolaryngology– Head and Neck Surgery, Western UniversityDepartment of Otolaryngology– Head and Neck Surgery, University Health Network, University of TorontoDepartment of Otolaryngology– Head and Neck Surgery, University Health Network, University of TorontoDepartment of Otolaryngology– Head and Neck Surgery, University Health Network, University of TorontoDepartment of Otolaryngology– Head and Neck Surgery, University Health Network, University of TorontoDepartment of Otolaryngology– Head and Neck Surgery, Sunnybrook Hospital, University of TorontoDepartment of Otolaryngology– Head and Neck Surgery, Sunnybrook Hospital, University of TorontoDepartment of Otolaryngology– Head and Neck Surgery, Sunnybrook Hospital, University of TorontoDivision of Otolaryngology– Head and Neck Surgery, McMaster UniversityDivision of Otolaryngology– Head and Neck Surgery, McMaster UniversityDivision of Otolaryngology– Head and Neck Surgery, McMaster UniversityDepartment of Otolaryngology– Head and Neck Surgery, University of OttawaDepartment of Electrical and Computer Engineering, Faculty of Applied Science, University of British ColumbiaDepartment of Mechancial Engineering, Faculty of Applied Science, University of British ColumbiaCentre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research InstituteSchool of Population and Public Health, Faculty of Medicine, University of British ColumbiaDepartment of Radiology, Faculty of Medicine, University of British ColumbiaDepartment of Orthopaedics, Faculty of Medicine, University of British ColumbiaFaculty of Dentistry, University of British ColumbiaFaculty of Dentistry, University of British ColumbiaDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British ColumbiaFaculty of Dentistry, University of British ColumbiaDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British ColumbiaDivision of Otolaryngology, Department of Surgery, Faculty of Medicine, University of British ColumbiaAbstract 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.https://doi.org/10.1186/s12885-025-13505-5Head and neck cancerOral cavityMandible ReconstructionVirtual Surgical PlanningQuality of lifeRandomized controlled trial |
| spellingShingle | 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 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 BMC Cancer Head and neck cancer Oral cavity Mandible Reconstruction Virtual Surgical Planning Quality of life Randomized controlled trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Head and neck cancer Oral cavity Mandible Reconstruction Virtual Surgical Planning Quality of life Randomized controlled trial |
| url | https://doi.org/10.1186/s12885-025-13505-5 |
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