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

NCT03364166 | Unknown

• 1 other identifier: NCT
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Squamous Cell Carcinoma of the Oral Cavity

Keywords

buccal squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• local control

  (recurrence rate)

  up to 1 year

Study Arms (2)

buccinator muscle excision with skin

ACTIVE COMPARATOR

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

Procedure: surgical excision

buccinator muscle excision without skin

ACTIVE COMPARATOR

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

Procedure: surgical excision

Interventions

surgical excision 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 with skin; buccinator muscle excision without skin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• ragia mounir, professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

ahmed yousef, PHD

CONTACT

01067941236; dr.ayousef@ymail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 6, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: December 6, 2017

Record last verified: 2017-11