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NCT Number: NCT07682467

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-Sen Memorial Hospital

Guangzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Wada Drinking Water experiment

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

    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.

Secondary outcomes

  1. speech articulation

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

    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.

  2. Appearance satisfaction

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

    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.

  3. Tumor recurrence and metastasis

    Time frame: 3 months, 6 months, 1 year and 2 years after surgery

    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.

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

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

Acronym: ALT-MF

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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