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

Squamous Cell Carcinoma of the Oral Cavity Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03364166
• Other study ID #: NCT
• Status: Not yet recruiting
• Phase: N/A
• First received: November 30, 2017
• Last updated: November 30, 2017
• Start date: December 2017
• Est. completion date: January 2019

Study information

• Verified date: November 2017
• Source: Cairo University
• Contact: ahmed yousef, PHD
• Phone: 01067941236
• Email: dr.ayousef[@]ymail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of the Oral Cavity

Intervention

Procedure:
• surgical excision
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local control	(recurrence rate)	up to 1 year