Submandibular Gland Preservation in Neck Dissection

Guang-Yan Yu

Status: Enrolling

Conditions: Neck Dislocation; Oral Cancer

Treatments: Procedure: modified neck dissection; Procedure: traditional neck dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT03385720

sujiazeng

Details and patient eligibility

About

Trial design: a randomized controlled trial.

Eligibility criteria for participants: patients with primary early stage oral squamous cell carcinoma. Exclusion criteria: cancer of the floor of the mouth.

Interventions: submandibular gland is preserved during neck dissection for patients of the experimental group; submandibular gland is removed during neck dissection for patients of the control group.

Primary Parameters: survival rate, mortality rate

Enrollment: 200 estimated patients

Sex: All

Ages: Under 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0).

Exclusion criteria

Cancer of the floor of the mouth.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Experimental group

Experimental group

Treatment:

Procedure: modified neck dissection

Control group

Active Comparator group

Treatment:

Procedure: traditional neck dissection