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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.

研究概览

研究类型

观察性的

注册 (实际的)

35

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Guangzhou、中国
        • Sun Yat-sen Memorial Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

取样方法

概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
ALT-MF
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Wada Drinking Water experiment
大体时间: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.
1week、1month、3months、6months、1year、2years after surgery

次要结果测量

结果测量
措施说明
大体时间
speech articulation
大体时间: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.
1week、1month、3months、6months、1year、2years after surgery
Appearance satisfaction
大体时间: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.
1week、1month、3months、6months、1year、2years after surgery
Tumor recurrence and metastasis
大体时间: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.
3 months, 6 months, 1 year and 2 years after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年5月15日

初级完成 (实际的)

2024年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2025年11月25日

首先提交符合 QC 标准的

2026年6月28日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年6月28日

最后验证

2025年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • SYSKY-2025-901-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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