Skip to content

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03364166
Enrollment
10
Registered
2017-12-06
Start date
2017-12-31
Completion date
2019-01-31
Last updated
2017-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma of the Oral Cavity

Keywords

buccal squamous cell carcinoma

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.

Interventions

* 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
local controlup to 1 year(recurrence rate)

Contacts

Primary Contactahmed yousef, PHD
dr.ayousef@ymail.com01067941236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026