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

NCT07682467 | Active Not Recruiting DMC

• 1 other identifier: SYSKY-2025-901-01
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tongue Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• speech articulation

  1week、1month、3months、6months、1year、2years after surgery

• Appearance satisfaction

  1week、1month、3months、6months、1year、2years after surgery

• Tumor recurrence and metastasis

  3 months, 6 months, 1 year and 2 years after surgery

Study Arms (2)

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

ALT

The anterolateral thigh muscle flap (ALT) repairs hemitongue defects in patients with tongue cancer

Interventions

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

ALT-MF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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;
• Body mass Index: BMI≥30 kg/m² (meeting the diagnostic criteria for obesity);
• Age and physical condition: 18-75 years old;
• 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;

You may not qualify if:

• 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.
• Underlying diseases: Severe cardiovascular and cerebrovascular diseases, coagulation disorders, diabetes, and severe infectious diseases;
• Patients with mental disorders are unable to cooperate with follow-up visits

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-Sen Memorial Hospital

Guangzhou, China

Location

MeSH Terms

Conditions

Tongue Neoplasms

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: July 6, 2026
• Study Start: May 15, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 6, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)