Clinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair : ( Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- operation time
研究概览
简要总结
Open reduction and internal fixation of zygomaticomaxillary complex (ZMC) fractures has a challenging impact on the selection of the suitable surgical approach to the orbital and zygomatic skeleton. Precise repair of the ZMC fractures needs a quite understanding of the regional anatomy, precise diagnosis, an accessible exposure, and an accurate rigid fixation of fracture to restore the normal form. The aesthetic results are one of the most important requirements for these incisions in facial fracture reduction. Conventional approaches to the infraorbital rim/orbital floor include transcutaneous as subciliary, subtarsal and infraorbital incisions and transconjunctival incision. A thorough understanding of each incisional technique requires an appreciation of the relevant anatomy putting in considerations the risk of associated complications.
Aim of this study:To compare between transconjunctival approach and transcutaneous approaches in open reduction of zygomaticomaxillary fracture.
Materials and methods: A study will be made on 75 patients who will undergo fracture repair of the zygomaticomaxillary complex. Twenty five of them (group A) will be treated via a subtarsal approach while. Other Twenty five patients (group B) via a transconjunctival approach. The remaining Twenty five patients (Group C) will be treated via infraorbital appeoach. Postoperative patient evaluation will be performed with specific attention paid towards, accessibility, the exposure duration (time from incision till exposure of the field), esthetic appearance ,postoperative pain, postoperative edema , wound healing, scaring, infection and postoperative ocular complications such as ectropion, entropion, scleral show and corneal abrasion. Postoperatively clinical examination along with radiographic examination will be done to evaluate the position of the zygoma and determine the adequacy of fracture reduction.
Results: will be statistically analyzed using the IBM Statistical Package for Social Science (SPSS) software version 22.0
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with orbital fractures (e.g., orbital floor or zygomaticomaxillary complex fractures) require open reduction with internal fixation.
- •Adult patient between 20 and 50 years with no gender predilections.
排除标准
- •• Existing lacerations in the inferior and lateral periorbital regions.
- •Comminuted fracture with bone loss.
- •Existence of infection at the fracture line.
- •Presence of acute or chronic conjunctival diseases.
研究组 & 干预措施
infraorbital approach
干预措施: orbital fracture reduction and fixation (Other)
subtarsal approach
干预措施: orbital fracture reduction and fixation (Other)
transconjunctival approach
干预措施: orbital fracture reduction and fixation (Other)
结局指标
主要结局
operation time
时间窗: intraopertive in minutes
starting from the skin incision till the reduction and fixation of the orbital rim
accessibility
时间窗: intraopertive
objective assessment by the main surgeon ( mild, moderate, excellent) accessibility
次要结局
- wound healing 1(1, 2 and 8 weeks)
研究者
mona oraby
lecturer
Alexandria University