CAS Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap

Completed

• Conditions: Complication of Surgical Procedure; Operation Time
• Interventions: Procedure: Computer-assisted surgery

• Registration Number: NCT04965441
• Lead Sponsor: KU Leuven

Brief Summary

A total of 153 patients who underwent mandibular reconstruction by VFF were included from Jan 1999 to Dec 2019. The mandibular resection and reconstruction were performed by four experienced oral and maxillofacial surgeons. Reasons for reconstruction were oncologic, osteoradionecrosis, trauma, and osteoporosis. All the patients were followed up postoperatively for at least one year. Eighteen pairs were formed with the matched cohort consisting of a total of 36 patients who underwent primary mandibular reconstruction without additional combined flaps. The surgery-related and patient-related continuous and categorical parameters were assessed in both groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-04-18
• Status Verified: 2021-07
• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-15
• Study First Posted: 2021-07-16
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• Clinical diagnosis of head and neck cancer
• Received mandibular reconstruction
• All patients were followed up postoperatively for at least one year

Exclusion Criteria

• Patients received bone graft for jaw reconstruction before mandibular reconstruction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Computer-assisted surgery (CAS) group	Computer-assisted surgery	-

Primary Outcome Measures

Name	Time	Method
operation time	within the surgery	operation time

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium