Efficacy of Endoscopic Transantral Versus Transorbital Surgical Approaches in the Repair of Orbital Blow-Out Fractures-Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 38
- 主要终点
- Diplopia resolution using Forced duction test positive/negative
研究概览
简要总结
Aim of this study is to assess the efficacy of endoscopic trans-maxillary surgical approach versus traditional trans-orbital surgical approach (control group) in orbital blow out fractures in terms of postoperative clinical and digital radio-graphical assessments.
详细描述
(N.M) Operator, data entry & corresponding author; Assistant lecturer , surgery department .
(I.E) Main supervisor, data monitoring & auditing; Professor, surgery department.
(R.H) Co-supervisor, data entry & auditing; Lecturer, surgery department . (AM) Assistant lecturer, surgery department .Faculty of Oral & Dental Medicine Cairo University outcome assessors and data collection.
(YA) Assistant Lecturer of Surgery department , faculty of oral and dental medicine - Cairo University , for baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents.
intervention:
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 (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with unilateral/bilateral orbital blow out fractures.
- •Positive forced-duction test. ( to ensure the muscular entrapment).
排除标准
- •Medical condition affecting bone healing.
- •Medically compromised conditions, not proper candidate for general anesthesia.
- •Tumor case encroaching on the orbital floor.
- •Pathological orbital blow out fractures.
- •Allergy/ metal hypersensitivity.
研究组 & 干预措施
endoscopic trans-antral approach
The maxillary sinus and prolapsed orbital contents will be visualized employing a 30-degree endoscope for the repair of orbital blow out fracture (sinus scope 4 mm, 30 degrees short one 17 cm).
干预措施: endoscopic trans-antral approach (Procedure)
trans-orbital surgical approach
trans-orbital surgical approach through the lower eyelid Sub-ciliary incision ( through the lower eyelid) The skin incision is made just below the eyelashes.
干预措施: trans-orbital surgical approach (Procedure)
结局指标
主要结局
Diplopia resolution using Forced duction test positive/negative
时间窗: 6 months
subjective patient assessment
次要结局
- Fracture reduction Digital radiography (Cone beam CT)(6 months)
- Enophthalmus correction. Digital radiography (Cone beam CT)(6 months)
研究者
Nahla Mahmoud Awad
Assistant lecturer , Oral and Maxillofacial surgery Department, Faculty of Oral & Dental Medicine Cairo University
Cairo University