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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Squamous Cell Carcinoma of the Oral Cavity

Intervention / Treatment
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* Procedure: surgical excision


Participation Criteria
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Eligibility Criteria
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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. 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: buccinator muscle excision with skin<br>surgical excision of the buccinator muscle with the skin in buccal squamous cell carcinoma and neck dissection also done | Procedure: surgical excision<br>* 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.<br>|
| Active Comparator: buccinator muscle excision without skin<br>surgical excision the buccinator muscle without the skin in buccal squamous cell carcinoma and neck dissection also done. | Procedure: surgical excision<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control | (recurrence rate) | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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buccal squamous cell carcinoma