Recurrence in Buccinator Muscle Excision With the Skin Versus Without the Skin in Buccal Squamous Cell Carcinoma
Primary Purpose
Squamous Cell Carcinoma of the Oral Cavity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgical excision
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Oral Cavity focused on measuring buccal squamous cell carcinoma
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
buccinator muscle excision with skin
buccinator muscle excision without skin
Arm Description
surgical excision of the buccinator muscle with the skin in buccal squamous cell carcinoma and neck dissection also done
surgical excision the buccinator muscle without the skin in buccal squamous cell carcinoma and neck dissection also done.
Outcomes
Primary Outcome Measures
local control
(recurrence rate)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03364166
Brief Title
Recurrence in Buccinator Muscle Excision With the Skin Versus Without the Skin in Buccal Squamous Cell Carcinoma
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Oral Cavity
Keywords
buccal squamous cell carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
buccinator muscle excision with skin
Arm Type
Active Comparator
Arm Description
surgical excision of the buccinator muscle with the skin in buccal squamous cell carcinoma and neck dissection also done
Arm Title
buccinator muscle excision without skin
Arm Type
Active Comparator
Arm Description
surgical excision the buccinator muscle without the skin in buccal squamous cell carcinoma and neck dissection also done.
Intervention Type
Procedure
Intervention Name(s)
surgical excision
Intervention Description
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.
Primary Outcome Measure Information:
Title
local control
Description
(recurrence rate)
Time Frame
up to 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed yousef, PHD
Phone
01067941236
Email
dr.ayousef@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ragia mounir, professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Recurrence in Buccinator Muscle Excision With the Skin Versus Without the Skin in Buccal Squamous Cell Carcinoma
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