Anterolateral Thigh Myofascial Fat Composite Flap for Reconstruction of Hemiglossectomy Defects in Obese Patients With Tongue Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Wada Drinking Water experiment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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
结局指标
主要结局
Wada Drinking Water experiment
时间窗: 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.
次要结局
- 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)