Virtual Planning of ALT Flap

University of Florida

Status: Withdrawn

Conditions: Tongue SCC

Treatments: Procedure: ALTF (Anterolateral thigh flap) with conventional method; Procedure: ALTF (Anterolateral thigh flap) with preoperative virtual planning

Study type: Interventional

Funder types: Other

Identifiers

NCT05424328

IRB202201118

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Study Group: ALTF with preoperative virtual planning

Experimental group

Description:

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

Treatment:

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

Control Group: ALTF with conventional method

Active Comparator group

Description:

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

Treatment:

Procedure: ALTF (Anterolateral thigh flap) with conventional method