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A single-center, prospective, randomized, controlled clinical study on the preservation of the contralateral submandibular gland during bilateral neck dissection for oral squamous cell carcinoma

A single-center, prospective, randomized, controlled clinical study on the preservation of the contralateral submandibular gland during bilateral neck dissection for oral squamous cell carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055838
Enrollment
Unknown
Registered
2022-01-20
Start date
2022-05-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

oral squamous cell carcinoma

Interventions

Experimental group:Preservation of the contralateral submandibular gland during bilateral neck dissection
control group:Resection of bilateral submandibular glands during bilateral neck dissection

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 oral squamous cell carcinoma; 3.Oral squamous cell carcinoma stage III-IVA; 4.No contralateral submandibular gland lesions; 5.No other oral mucosal lesions; 6.The vital signs are stable, and the routine examination shows that the operation can be tolerated; 7.Preoperative imaging report suggests ipsilateral lymph node metastasis of the primary tumor; 8.Those who need postoperative adjuvant radiotherapy; 9.The patient is in good mental state, can follow the doctor's orders, and have regular follow-up visits; 10.Understand and be willing to participate in this clinical trial and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Pre-existing diseases that affect salivary secretion (such as autoimmune diseases); 2.Uncontrolled hyperglycemia (such as HbA1c >12.0%); 3.Those with severe uncontrolled disease or acute systemic infection, and those with other serious heart, lung, encephalopathy and other serious organ diseases; 4.Patients with psychiatric diseases; 5.Those who are considered inappropriate by the researchers; 6.The patient participated in this study at any time in the past; 7.Patients with cervical lymph node metastasis on the opposite side of the primary tumor were found by intraoperative pathological results

Design outcomes

Primary

MeasureTime frame
saliva secretion;

Secondary

MeasureTime frame
Survival state;Recurrence or metastasis;VAS pain score;University of Washington Quality of Life Questionnaire;

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