Mandibular Reconstruction Preplanning (ViPMR)

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Tongue neoplasm
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Brief Title

Mandibular Reconstruction Preplanning (ViPMR)

Official Title

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

Brief Summary

      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.

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Bony Union

Secondary Outcome

 Difference in Intracondylar Distance

Condition

Oral Cavity Cancer

Intervention

Virtual Surgical Planning (VSP)

Study Arms / Comparison Groups

 Free-Hand Surgery (FHS)
Description:  In FHS, the site surgeon will proceed with the surgery as per their routine practice.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

315

Start Date

September 1, 2022

Completion Date

September 1, 2026

Primary Completion Date

September 1, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 6048754126, [email protected]

Administrative Informations

NCT ID

NCT05429099

Organization ID

H20-03314

Responsible Party

Principal Investigator

Study Sponsor

University of British Columbia

Study Sponsor

, ,

Verification Date

June 2022