Clinical Trials Logo

Clinical Trial Summary

This study evaluates the advantage of using preoperative virtual planning to design the volume and shape of antero-lateral thigh free flap tissue transfer to reconstruct tongue defects resulted from carcinoma resection and see how this would affect tongue form and speech function.


Clinical Trial Description

This is a prospective randomized clinical study consisting of 2 groups A and B each contains 10 patients of total 20 patients. Where group A (control group) where Alt flap harvest for tongue reconstruction after hemi glossectomy is done with the conventional method while group B (study group) the Alt flap design and harvest is virtually planned before the operation. The main issue regarding tongue reconstruction with ALTF is the matching of the size and shape between the harvested flap and the tongue defect assuming the hypothesis that an adequate flap volume is crucial for maintaining tongue function. Meanwhile, the preoperative planning of soft tissues is relatively difficult due to an undefined standardization and reference points. In this study, investigators will evaluate the use of preoperative virtual planning and 3D reconstructions for the restoration of tongue defects with ALTF. In this study, virtual surgical planning for the resection of the tongue cancer (hemi-glossectomy) will be used and will address flap design, which the investigators will base on anatomical landmarks using the preoperative virtual planning technology. The research team will compare the functional ( speech) and cosmetic outcomes of the virtually planned ALTF technique with the conventional method for hemi-glossectomy and reconstruction. The null hypothesis of this study is that there is no significant difference in functional & cosmetic outcome between the virtually planned ALTF technique with the conventional method for hemi-glossectomy and reconstruction. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05424328
Study type Interventional
Source University of Florida
Contact
Status Not yet recruiting
Phase N/A
Start date September 2023
Completion date September 2025

See also
  Status Clinical Trial Phase
Completed NCT04614896 - Use of Ultrasound for Measuring Size of Oral Tongue Cancers N/A
Not yet recruiting NCT05843032 - 3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment N/A