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临床试验/NCT03364166
NCT03364166Unknown不适用

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.

Cairo University0 个研究点目标入组 10 人开始时间: 2017年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
主要终点
local control

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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

干预措施: surgical excision (Procedure)

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.

干预措施: surgical excision (Procedure)

结局指标

主要结局

local control

时间窗: up to 1 year

(recurrence rate)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Yuseef

principle investigator

Cairo University

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