Clinical trial NCT05424328: Virtual Planning of ALT Flap
Official title: Virtual Planning Of Anterolateral Thigh Free Flap for Reconstruction Of Hemiglossectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tongue SCC
Keywords: SCC, Hemi glossectomy, ALT Flap. virtual planning
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Prospectively evaluate a new method of virtually planned ALTF and changes in flap volume for the reconstruction of tongue defects following hemi-glossectomy
timeFrame: 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:
measure: Assessment of Intelligibility of Dysarthric Speech (AIDS) test will be used to assess tongue speech functions following tongue reconstruction and compare speech changes.
timeFrame: Changes of speech will be compared After one and six months after surgery where the preoperative speech will be the base line.
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Rui Fernandes, MD, DMD
role: PRINCIPAL_INVESTIGATOR
References: