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.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Guangzhou、中国
- Sun Yat-Sen Memorial Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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ALT-MF
The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer
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The anterolateral femoral myofascial fat composite flap (ALT-MF) repairs tongue defects in patients with tongue cancer
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ALT
The anterolateral thigh muscle flap (ALT) repairs hemitongue defects in patients with tongue cancer
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Wada Drinking Water experiment
時間枠：1week、1month、3months、6months、1year、2years after surgery
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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.
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1week、1month、3months、6months、1year、2years after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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speech articulation
時間枠：1week、1month、3months、6months、1year、2years after surgery
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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.
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1week、1month、3months、6months、1year、2years after surgery
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Appearance satisfaction
時間枠：1week、1month、3months、6months、1year、2years after surgery
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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.
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1week、1month、3months、6months、1year、2years after surgery
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Tumor recurrence and metastasis
時間枠：3 months, 6 months, 1 year and 2 years after surgery
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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.
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3 months, 6 months, 1 year and 2 years after surgery
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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