Virtual Planning of ALT Flap

NCT05424328 | Withdrawn

• 1 other identifier: IRB202201118
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tongue SCC

Keywords

SCC, Hemi glossectomy, ALT Flap. virtual planning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of Intelligibility of Dysarthric Speech (AIDS) test will be used to assess tongue speech functions following tongue reconstruction and compare speech changes.

  Changes of speech will be compared After one and six months after surgery where the preoperative speech will be the base line.

Study Arms (2)

Study Group: ALTF with preoperative virtual planning

EXPERIMENTAL

Subjects will receive ALTF( Anterolateral thigh flap) with preoperative virtual planning

Procedure: ALTF (Anterolateral thigh flap) with preoperative virtual planning

Control Group: ALTF with conventional method

ACTIVE COMPARATOR

Subjects will receive ALTF (Anterolateral thigh flap) with conventional method

Procedure: ALTF (Anterolateral thigh flap) with conventional method

Interventions

ALTF (Anterolateral thigh flap) with preoperative virtual planning PROCEDURE

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.

Study Group: ALTF with preoperative virtual planning

ALTF (Anterolateral thigh flap) with conventional method PROCEDURE

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.

Control Group: ALTF with conventional method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary tongue squamous cell carcinoma (SCC) requiring hemi-glossectomy.
• No alveolar ridge involvement by the tumor process.
• Planned to undergo tongue reconstruction using ALTF.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Officials

• Rui Fernandes, MD, DMD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study consists 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 where flap design and volume depends on surgeon's own experience while group B (study group) the Alt flap design and volume will be harvested by the aid of a guide that is virtually planned before the operation.

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 21, 2022
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share