Recurrence in Buccinator Muscle Excision With the Skin Versus Without the Skin in Buccal Squamous Cell Carcinoma

Not Applicable

• Conditions: Squamous Cell Carcinoma of the Oral Cavity
• Interventions: Procedure: surgical excision

• Registration Number: NCT03364166
• Lead Sponsor: Cairo University

Brief Summary

Evaluation of local control in buccinator muscle excision with the skin versus buccinator muscle excision without the skin in buccal squamous cell carcinoma: A randomized clinical trial.

Detailed Description

Preoperative Multi Slice CT scan or MRI carried out for evaluation the lymph node of the neck. Also, ultrasound carried out for measuring the depth of invasion of the tumour in the cheek (The invasion in the buccinator muscle).

* Under general anaesthesia, the buccal squamous cell carcinoma which invaded the buccinator muscle will be excised with the skin of the cheek. This will be done by a safety margins in the soft tissue and the mandible may be resected according to the plan and the invasion of the tumour.

* A neck dissection will be done in all cases of negative or positive neck lymph node.

* Reconstruction of the soft tissue will be done immediately by a major pectorals flap with the skin, also bony reconstruction may be done by a reconstructed plate at the time of surgery then the patients will be prepared for bone graft in another surgery.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-11-30
• Last Update Submitted: 2017-11-30
• Study Start: 2017-12
• Study First Posted: 2017-12-06
• Last Update Posted: 2017-12-06
• Primary Completion: 2018-12
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients suffering from buccal squamous cell carcinoma.
• Patients should be free from any systemic disease that may affect normal healing, and predictable outcome.
• Both sexes and all ages will be included in the study.
• Cooperative patients, who accept the procedure and return for follow up , examination and evaluation.

Read More

Exclusion Criteria

• Patients with any systemic disease that may affect normal healing.9,10
• Patients who physically and psychologically not able to tolerate the procedures.
• Patients may discontinue the follow up.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
buccinator muscle excision without skin	surgical excision	surgical excision the buccinator muscle without the skin in buccal squamous cell carcinoma and neck dissection also done.
buccinator muscle excision with skin	surgical excision	surgical excision of the buccinator muscle with the skin in buccal squamous cell carcinoma and neck dissection also done

Primary Outcome Measures

Name	Time	Method
local control	up to 1 year	(recurrence rate)