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

NCT ID: NCT03364166

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2019-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Squamous Cell Carcinoma of the Oral Cavity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

buccal squamous cell carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

buccinator muscle excision with skin

surgical excision of the buccinator muscle with the skin in buccal squamous cell carcinoma and neck dissection also done

Group Type ACTIVE_COMPARATOR

surgical excision

Intervention Type PROCEDURE

* 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.

buccinator muscle excision without skin

surgical excision the buccinator muscle without the skin in buccal squamous cell carcinoma and neck dissection also done.

Group Type ACTIVE_COMPARATOR

surgical excision

Intervention Type PROCEDURE

* 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Yuseef

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ragia mounir, professor

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

ahmed yousef, PHD

Role: CONTACT

Phone: 01067941236

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCT

Identifier Type: -

Identifier Source: org_study_id