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A Single-Center, Prospective, Randomized, Controlled Clinical Study of Tongue Squamous Cell Carcinoma Radical Surgery and Simultaneous Free Flap Repair in the Submental-mandibular Dehiscence Approach

A Single-Center, Prospective, Randomized, Controlled Clinical Study of Tongue Squamous Cell Carcinoma Radical Surgery and Simultaneous Free Flap Repair in the Submental-mandibular Dehiscence Approach

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055608
Enrollment
Unknown
Registered
2022-01-14
Start date
2022-05-01
Completion date
Unknown
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tongue squamous cell carcinoma

Interventions

Experimental group:submental-submandibular dehiscence approach
Control group:Median split lower lip approach

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The age of the patient on the day of signing the informed consent is 18 years old or above; 2. The pathological diagnosis is tongue squamous cell carcinoma; 3. The primary tumor size of tongue cancer is T2-T3, the preoperative clinical examination and imaging examination are negative for cervical lymph node (cN0), and the distant metastasis is M0; 4. There are no old scars and other lesions on the lower lip and chin; 5. The vital signs are stable, and the routine examination shows that the operation can be tolerated; 6. The patient is in good mental state, can follow the doctor's orders, and have regular follow-up visits; 7. Understand and be willing to participate in this clinical trial and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Pre-existing disease will affect wound healing (such as autoimmune disease); 2. Scar constitution; 3. Uncontrolled hyperglycemia (such as HbA1c > 12.0%); 4. Patients who need postoperative adjuvant radiotherapy/chemotherapy after consultation with radiotherapy physicians; 5. Those with severe uncontrolled disease or acute systemic infection, and those with other serious heart, lung, encephalopathy and other serious organ diseases; 6. Patients with psychiatric diseases; 7. Those who are considered inappropriate by the researchers to be included; 8. The patient participated in this study at any time in the past.

Design outcomes

Primary

MeasureTime frame
University of Washington Quality of Life Questionnaire;

Secondary

MeasureTime frame
3-year overall survival rate;3-year disease-free survival rate;Vancouver Scar Scale;

Countries

China

Contacts

Public ContactWang Youyuan

Department of Oral and Maxillofacial Surgery, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

wangyy78@mail.sysu.edu.cn+86 13631333312

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026