Anterolateral Thigh Myofascial Fat Composite Flap for Reconstruction of Hemiglossectomy Defects i… (NCT07682467) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Anterolateral Thigh Myofascial Fat Composite Flap for Reconstruction of Hemiglossectomy Defects in Obese Patients With Tongue Cancer
China35 participantsStarted 2023-05-15
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Wada Drinking Water experiment
Timeframe: 1week、1month、3months、6months、1year、2years after surgery
Trial details
NCT IDNCT07682467
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University