Virtual Planning of ALT Flap

NCT ID: NCT05424328

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2025-09-30

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.

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.

Conditions

Tongue SCC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Group: ALTF with preoperative virtual planning

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

Group Type: EXPERIMENTAL

ALTF (Anterolateral thigh flap) with preoperative virtual planning

Intervention Type: 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.

Control Group: ALTF with conventional method

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

Group Type: ACTIVE_COMPARATOR

ALTF (Anterolateral thigh flap) with conventional method

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rui Fernandes, MD, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

IRB202201118

Identifier Type: -

Identifier Source: org_study_id