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NCT07682467
Anterolateral Thigh Myofascial Fat Composite Flap for Reconstruction of Hemiglossectomy Defects in Obese Patients With Tongue Cancer
Conditions: Tongue Cancer
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 35
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Location: Sun Yat-Sen Memorial Hospital Guangzhou
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07682467). StuddyBuddy aggregates publicly available trial information.