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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Squamous Cell Carcinoma of the Oral Cavity
• Intervention / Treatment: Procedure: surgical excision

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ahmed yousef, PHD; Phone Number: 01067941236; Email: dr.ayousef@ymail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: buccinator muscle excision with skin; surgical excision of the buccinator muscle with the skin in buccal squamous cell carcinoma and neck dissection also done	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.
Active Comparator: buccinator muscle excision without skin; surgical excision the buccinator muscle without the skin in buccal squamous cell carcinoma and neck dissection also done.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: ragia mounir, professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: buccal squamous cell carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: NCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No