Anterolateral Thigh Myofascial Fat Composite Flap for Reconstruction of Hemiglossectomy Defects in Obese Patients With Tongue Cancer (ALT-MF)

Anterolateral Thigh Myofascial Fat Composite Flap for Reconstruction of Hemiglossectomy Defects in Obese Patients With Tongue Cancer: A Pilot Study

Tongue cancer is a common malignant tumor in oral and maxillofacial surgery. After surgical resection, it is often accompanied by hemitongue defect. For obese patients (BMI≥30) with tongue cancer, the repair of hemitongue defect is due to thick subcutaneous fat and bloated traditional free flaps, which leads to swallowing and speech dysfunction. As a result, there is still a lack of good clinical repair plans at present, which seriously affects the quality of life of patients. There is an urgent need for safe and efficient targeted repair techniques.

This study intends to retrospectively collect 35 patients with hemitongue defects after surgery for obese (BMI≥30) tongue squamous cell carcinoma in a single center, to compare the repair effects of ALT-MF and traditional free flaps, and to evaluate the postoperative Wada drinking water test scores, speech acuity, etc. of the two groups of patients. This study explores solutions to problems such as bloat, slow functional recovery, and significant donor site damage caused by traditional repair techniques in obese patients, verifies the safety and efficacy of ALT-MF, clarifies the repair mechanism, provides a new strategy for hemitongue defect repair in obese tongue cancer patients, improves the quality of life of patients, and has important clinical value and social significance.

Study Overview

• Status: Active, not recruiting
• Conditions: Tongue Cancer
• Intervention / Treatment: Procedure: The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Sun Yat-Sen Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with hemitongue defect after surgery for obese (BMI≥30) tongue squamous cell carcinoma

Description

Inclusion Criteria:

1. Disease and surgical indications: Pathologically confirmed as tongue squamous cell carcinoma, having received surgical treatment (hemitongue resection + free flap repair), tumor stage is T1-T2 (according to AJCC 7th Edition), N0-N1 stage, M0 stage;
2. Body mass Index: BMI≥30 kg/m² (meeting the diagnostic criteria for obesity);
3. Age and physical condition: 18-75 years old;
4. Cooperation: Follow the doctor's advice for follow-up after the operation and be able to cooperate with the assessment of swallowing and speech functions;

Exclusion Criteria:

1. Disease-related: If the tumor invades the base of the tongue or extends beyond half of the tongue, an extended resection is performed; Combined with extensive cervical lymph node metastasis (N2 or above) or distant metastasis (M1 stage); There is a previous history of radiotherapy or surgery for head and neck tumors.
2. Underlying diseases: Severe cardiovascular and cerebrovascular diseases, coagulation disorders, diabetes, and severe infectious diseases;
3. Patients with mental disorders are unable to cooperate with follow-up visits

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ALT-MF; The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer	Procedure: The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer; The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer
ALT; The anterolateral thigh muscle flap (ALT) repairs hemitongue defects in patients with tongue cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wada Drinking Water experiment	The drinking process and response are observed. The assessment criteria are divided into 5 levels: able to drink all of the water at one time without choking, level 1 is normal; drinking all of the water in two attempts without choking, level 2 is suspicious; able to drink all of the water in one attempt but with choking, level 3 indicates mild swallowing disorder; drinking all of the water in more than two attempts with choking, level 4 indicates moderate disorder; and frequent choking and difficulty in drinking all of the water, level 5 indicates severe swallowing disorder.	1week、1month、3months、6months、1year、2years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
speech articulation	Speech intelligibility was assessed using a 7-point scale: 7 points for complete speech; 6 points for occasional speech errors; 5 points for intelligible speech with obvious errors; 4 points for speech that can be understood only by careful listening; 3 points for speech that can be understood only by repeated pronunciation; 2 points for speech that is generally unintelligible; and 1 point for speech that is unintelligible.	1week、1month、3months、6months、1year、2years after surgery
Appearance satisfaction	To assess patient satisfaction with postoperative appearance, the 4th edition of the UW-QoL was used: 5 points for normal appearance; 4 points for minor changes in appearance; 3 points for changes that are bothersome but allow the patient to maintain a normal life; 2 points for changes that are bothersome and affect social activities; and 1 point for changes in appearance that make it difficult to interact with others.	1week、1month、3months、6months、1year、2years after surgery
Tumor recurrence and metastasis	Tumor recurrence or metastasis should also be monitored. CT/MRI scans should be performed every 6 months for 2 years after surgery to monitor for tumor recurrence and metastasis. For patients with suspected recurrence or metastasis, further diagnostic tests, such as pathological biopsy and positron emission tomography-computed tomography (PET-CT), were conducted to confirm the diagnosis and guide subsequent treatment.	3 months, 6 months, 1 year and 2 years after surgery

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Tongue Diseases; Mouth Neoplasms; Tongue Neoplasms
• Other Study ID Numbers: SYSKY-2025-901-01

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