the Versatility of Periosteal Muscular Flap in Reconstruction of Small and Medium Sized Defects at Floor of the Mouth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in pain scores
研究概览
简要总结
Background: Rebuilding head and neck defects is a chief challenge to the maxillofacial surgeons especially after cancer resection, trauma, infection and craniofacial deformities. Earlier, the use of obturators for many years has been a successful treatment plan. However, recently several surgical modalities are available for the restoration of such defects as locoregional or microvascular free flaps.
Aim: To assess the reliability of the lateral periosteal-muscular flap in the reconstruction of small and medium sized floor of the mouth defects.
Main outcome: To evaluate functional outcomes (Including speech, tongue mobility, deglutition, flap viability), pain, complications such as trismus, flap necrosis, dehiscence, infection, fistula formation or donor site morbidity and aesthetic outcomes. Mean harvesting time and flap dimensions will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring reconstruction of small and medium sized FOM defects.
排除标准
- •Previous neck dissection.
- •Previous radiotherapy in the maxillofacial region.
- •Uncontrolled diseases that may contraindicate the surgery
研究组 & 干预措施
lateral periosteal-muscular flap prospectively
干预措施: Lateral periosteal-muscular flap (Procedure)
结局指标
主要结局
Change in pain scores
时间窗: up to 6 months
Pain will be evaluated using a 10-cm visual analogue scale (VAS).
Change in aesthetic assessment
时间窗: up to 6 months
The aesthetic results will be assessed as excellent (E), good (G), acceptable (A) and poor (P).
次要结局
- post-operative complication(up to 6 months)