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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 30, 2017
    Last Updated
    November 30, 2017
    Sponsor
    Cairo University
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    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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