Virtual Planning of ALT Flap

Virtual Planning Of Anterolateral Thigh Free Flap for Reconstruction Of Hemiglossectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tongue SCC
• Intervention / Treatment: Procedure: ALTF (Anterolateral thigh flap) with preoperative virtual planning; Procedure: ALTF (Anterolateral thigh flap) with conventional method

Detailed 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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with primary tongue squamous cell carcinoma (SCC) requiring hemi-glossectomy.
2. No alveolar ridge involvement by the tumor process.
3. Planned to undergo tongue reconstruction using ALTF.
4. Patients with a depth of invasion more than 10mm but not crossing midline according to the classification of Ansarin et. al., we perform type IIIA glossectomy.

Exclusion Criteria:

1. Medically unfit patients; those who are not good candidates for long microvascular surgical reconstructive procedures e.g.: advanced Cardiopulmonary diseases.
2. Recurrent tongue carcinoma.
3. Patients with lesions invading the alveolar ridge.
4. Missing or non-compliance for imaging investigations.
5. Patients underwent preoperative adjuvant therapies.
6. No children will be involved in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group: ALTF with preoperative virtual planning; Subjects will receive ALTF( Anterolateral thigh flap) with preoperative virtual planning	Procedure: ALTF (Anterolateral thigh flap) with preoperative virtual planning; In this study group, using preoperative CTs (head & neck and thigh ) to virtually plan a guide that can be used during the surgery, this guide will determine the design and dimensions of the Alt flap to be harvested and restore the defect left on the tongue due SCC resection and hemi glossectomy.
Active Comparator: Control Group: ALTF with conventional method; Subjects will receive ALTF (Anterolateral thigh flap) with conventional method	Procedure: ALTF (Anterolateral thigh flap) with conventional method; ALTF (Anterolateral thigh flap) will be harvested with conventional method which depends on surgeon's own experience in determining the flap design and dimensions needed to reconstruct and restore the defect left on the tongue due SCC resection and hemi glossectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prospectively evaluate a new method of virtually planned ALTF and changes in flap volume for the reconstruction of tongue defects following hemi-glossectomy	Investigators will preoperatively use CT measurements and virtual planning 3D software to calculate the required ALT flap volume /cm3 by measuring flap dimensions (height, width and length) /cm3 and compare it with the postoperative real outcomes by re-measuring the real flap dimensions ( height, width and length) /cm3 .	Changes in flap volume/cm3 will be measured after one and six months after surgery where the preoperative virtually planned volume/cm3 is being the base line.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Intelligibility of Dysarthric Speech (AIDS) test will be used to assess tongue speech functions following tongue reconstruction and compare speech changes.	- In the AIDS test the speech analysist examiner will randomly select two sentences (5-15 words) for a total of 22 sentences utilizing table in manual, and reads them aloud once and then allow patients to say them while audio records each session via voice app on phone. Judge from the investigators will listen and transcribe. Making a report and develop outcomes.; Scoring will be according the standard scores of the AIDS test analysis where:; Intelligibility: Corresponds to number of correct words.; Speaking rate: Corresponds to words per minute (WPM) / duration of sentence samples in minutes; Rate of intelligible speech (intelligible words per minute (IWPM)): number of words identified correctly /total duration; Rate of unintelligible (unintelligible words per minute (UWPM)): number of unintelligible/total duration; Communication efficiency ratio: IWPM/190 IWPM.	Changes of speech will be compared After one and six months after surgery where the preoperative speech will be the base line.

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Rui Fernandes, MD, DMD, University of Florida

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: SCC, Hemi glossectomy, ALT Flap. virtual planning
• Other Study ID Numbers: IRB202201118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No