Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-02-20 @ 10:12 PM
Study NCT ID:
NCT03364166
Status:
UNKNOWN
Last Update Posted:
2017-12-06
First Post:
2017-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recurrence in Buccinator Muscle Excision With the Skin Versus Without the Skin in Buccal Squamous Cell Carcinoma
Sponsor:
Cairo University
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: