Comparison of the Efficacy of Transconjunctival Approach without Lateral Canthotomy with Infraorbital Approach for the Management of Fractures involving Infraorbital Rim: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- INTRA OPERATIVE PARAMETERS
研究概览
简要总结
Facial injuries such as zygomaticomaxillary complex fractures, Lefort II fractures and orbital fractures may involve the fracture of infraorbital rim. There are varieties of surgical approaches to the infraorbital rim exists and broadly they can be categories as transcutaneous and transconjunctival approach. Transcutaneous approach are further divided as infraciliary incision also known as sub ciliary incision, mid lower eyelid or sub tarsal and infraorbital incisions. These approaches leave behind a scar which may be cosmetically disfiguring at times. An alternate method that avoids the cutaneous scar with adequate exposure is, the use of a transconjunctival incision placed through the conjunctiva. Bourquett described this approach, however it was Tessier who popularized it. The enthusiasts of this approach used it primarily for correction of congenital anomalies of the orbit. McCord and Moses popularized the use of transconjunctival incision for traumatic deformities of the orbit coupled with lateral canthotomy. This allowed the lower eyelid to swing downwards widely, providing adequate exposure of the orbital floor. The sub ciliary incision is made 2mm caudal to the cilial line. The sub tarsal incision placed parallel to the ciliary margin just caudal to the tarsus. The infraorbital incision is designed to lie in a skin crease at the level of the bony orbital margin. Although it may seem that the difference lies only at the level of the incision from the ciliary margin, the anatomy of the region and the plane of dissection also influence the final esthetic result. Complications have also been cited as related to a particular incision used. Although transconjunctival approach is having its own list of complications but it is esthetically pleasing as compared to infraorbital approach.
Many authors used an additional lateral canthotomy to provide better access to infraorbital rim and orbital floor. Lorenz et al popularized that there is no need of lateral canthotomy to expose orbital floor and orbital rim.Many studies are available regarding comparison of transconjunctival approach with lateral canthotomy to infraorbital approach. But there is a scarcity of literature regarding transconjunctival approach without canthotomy to infraorbital approach. So the purpose of the present study is to compare the infraorbital approach with transconjunctival approach without lateral canthotomy for the management of fractures involving the infra orbital rim.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between age of 18-70 years of both genders.
- •Patients with clinical and radiological evidence of infraorbital rim fractures which requires open reduction and internal fixation.
- •Healthy patients falling under ASA I and ASA II
- •Subjects able and willing to provide written informed consent and compliant with study procedure.
排除标准
- •Patients with contused or lacerated wound in lower eyelid.
- •Patients with open globe injury or hyphema, conjunctival pathology, ocular surface or glaucoma.
- •Patients having any systemic or local immunodeficiency.
- •Patients with osteoporosis and osteopetrosis
- •Patients with medical co-morbidities
- •Having any blood coagulation impairment.
- •Have been suffering with uncontrolled diabetes or other systemic diseases.
结局指标
主要结局
INTRA OPERATIVE PARAMETERS
时间窗: INTRA OPERATIVE PARAMETERS | 1) Surgical time to expose the fracture site | 2) Surgeon’s satisfaction for the stability of plate | POST OPERATIVE PARAMETERS | 1) Pain on 3rd day, 7th day, 15th day and 1 month | 2) Eyelid oedema on 3rd day, 7th day, 15th day and 1 month | 3) Ecchymosis on 3rd day, 7th day, 15th day and 1 month | 4) Epiphora on 3rd day, 7th day, 15th day and 1 month | 5) Scar on 3rd day, 7th day, 15th day and 1 month
1) Surgical time to expose the fracture site
时间窗: INTRA OPERATIVE PARAMETERS | 1) Surgical time to expose the fracture site | 2) Surgeon’s satisfaction for the stability of plate | POST OPERATIVE PARAMETERS | 1) Pain on 3rd day, 7th day, 15th day and 1 month | 2) Eyelid oedema on 3rd day, 7th day, 15th day and 1 month | 3) Ecchymosis on 3rd day, 7th day, 15th day and 1 month | 4) Epiphora on 3rd day, 7th day, 15th day and 1 month | 5) Scar on 3rd day, 7th day, 15th day and 1 month
2) Surgeon’s satisfaction for the stability of plate
时间窗: INTRA OPERATIVE PARAMETERS | 1) Surgical time to expose the fracture site | 2) Surgeon’s satisfaction for the stability of plate | POST OPERATIVE PARAMETERS | 1) Pain on 3rd day, 7th day, 15th day and 1 month | 2) Eyelid oedema on 3rd day, 7th day, 15th day and 1 month | 3) Ecchymosis on 3rd day, 7th day, 15th day and 1 month | 4) Epiphora on 3rd day, 7th day, 15th day and 1 month | 5) Scar on 3rd day, 7th day, 15th day and 1 month
POST OPERATIVE PARAMETERS
时间窗: INTRA OPERATIVE PARAMETERS | 1) Surgical time to expose the fracture site | 2) Surgeon’s satisfaction for the stability of plate | POST OPERATIVE PARAMETERS | 1) Pain on 3rd day, 7th day, 15th day and 1 month | 2) Eyelid oedema on 3rd day, 7th day, 15th day and 1 month | 3) Ecchymosis on 3rd day, 7th day, 15th day and 1 month | 4) Epiphora on 3rd day, 7th day, 15th day and 1 month | 5) Scar on 3rd day, 7th day, 15th day and 1 month
1) Pain
时间窗: INTRA OPERATIVE PARAMETERS | 1) Surgical time to expose the fracture site | 2) Surgeon’s satisfaction for the stability of plate | POST OPERATIVE PARAMETERS | 1) Pain on 3rd day, 7th day, 15th day and 1 month | 2) Eyelid oedema on 3rd day, 7th day, 15th day and 1 month | 3) Ecchymosis on 3rd day, 7th day, 15th day and 1 month | 4) Epiphora on 3rd day, 7th day, 15th day and 1 month | 5) Scar on 3rd day, 7th day, 15th day and 1 month
2) Eyelid oedema
时间窗: INTRA OPERATIVE PARAMETERS | 1) Surgical time to expose the fracture site | 2) Surgeon’s satisfaction for the stability of plate | POST OPERATIVE PARAMETERS | 1) Pain on 3rd day, 7th day, 15th day and 1 month | 2) Eyelid oedema on 3rd day, 7th day, 15th day and 1 month | 3) Ecchymosis on 3rd day, 7th day, 15th day and 1 month | 4) Epiphora on 3rd day, 7th day, 15th day and 1 month | 5) Scar on 3rd day, 7th day, 15th day and 1 month
3) Ecchymosis
时间窗: INTRA OPERATIVE PARAMETERS | 1) Surgical time to expose the fracture site | 2) Surgeon’s satisfaction for the stability of plate | POST OPERATIVE PARAMETERS | 1) Pain on 3rd day, 7th day, 15th day and 1 month | 2) Eyelid oedema on 3rd day, 7th day, 15th day and 1 month | 3) Ecchymosis on 3rd day, 7th day, 15th day and 1 month | 4) Epiphora on 3rd day, 7th day, 15th day and 1 month | 5) Scar on 3rd day, 7th day, 15th day and 1 month
4) Epiphora
时间窗: INTRA OPERATIVE PARAMETERS | 1) Surgical time to expose the fracture site | 2) Surgeon’s satisfaction for the stability of plate | POST OPERATIVE PARAMETERS | 1) Pain on 3rd day, 7th day, 15th day and 1 month | 2) Eyelid oedema on 3rd day, 7th day, 15th day and 1 month | 3) Ecchymosis on 3rd day, 7th day, 15th day and 1 month | 4) Epiphora on 3rd day, 7th day, 15th day and 1 month | 5) Scar on 3rd day, 7th day, 15th day and 1 month
5) Scar
时间窗: INTRA OPERATIVE PARAMETERS | 1) Surgical time to expose the fracture site | 2) Surgeon’s satisfaction for the stability of plate | POST OPERATIVE PARAMETERS | 1) Pain on 3rd day, 7th day, 15th day and 1 month | 2) Eyelid oedema on 3rd day, 7th day, 15th day and 1 month | 3) Ecchymosis on 3rd day, 7th day, 15th day and 1 month | 4) Epiphora on 3rd day, 7th day, 15th day and 1 month | 5) Scar on 3rd day, 7th day, 15th day and 1 month
次要结局
- POST OPERATIVE PARAMETERS(• Ectropion)
研究者
Dr Aishwarya Babhulkar
Geetanjali Dental and Research Insitute