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临床试验/NCT02319954
NCT02319954已完成不适用

Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema

Lawson Health Research Institute0 个研究点目标入组 16 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
主要终点
Periorbital edema and ecchymosis

研究概览

简要总结

Periorbital edema and ecchymosis are common morbidities in the post-operative period after rhinoplasty. Lateral osteotomy techniques used to reshape the bony nasal pyramid are large contributing factors to the degree of bruising and edema. This is due to injury to the angular vessels that are crossing the osteotomy sites. Depending on the degree of swelling and bruising, it can cause difficulty with visual acuity in the early post-operative period. Most importantly, this can be quite distressing to the patient and impact the time required to return to normal social activities. Numerous studies have examined various interventions to reduce periorbital swelling and ecchymosis. These include peri-operative steroids, lidocaine with epinephrine injections, fibrin sealant, permissive intra-operative hypotension and subperiosteal osteotomy techniques. Peri-operative steroids have been most extensively studied. Recent meta-analysis by Hatef et al, found that pre-operative steroids were effective for decreasing post-operative edema and ecchymosis. Steroids however, carry with it the risks of psychosis, immunosuppression, weight gain, uncontrolled blood glucose and avascular necrosis of the hip. As such, broadly applicable and cost-effective techniques to minimize post-operative edema and ecchymosis without the risk profile of steroids would be ideal. Taskin et al. recently examined the efficacy of the combination of intraoperative cold saline-soaked gauze compression and corticosteroids on rhinoplasty morbidity. The study group received compression with a cold saline soaked gauze to the nasal dorsum during the surgery and the control group received compression with a dry gauze. Both groups received a pre-operative dose of intravenous steroids. The study group had significantly less periorbital edema and ecchymosis on post-operative days 1, 3, 5 and 7. This study unfortunately did not examine the role of compression alone and the study was performed in the presence of steroids, which is not routinely utilized by all surgeons. As such, the proposed study will provide evidence for the use of direct compression intra-operatively after lateral osteotomy in order to reduce post-operative edema and ecchymosis. The findings of this study may provide a simple, effective and non-costly technique to minimize the morbidity of rhinoplasty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients (18 years old and greater) undergoing rhinoplasty requiring lateral osteotomy

排除标准

  • Patients taking anti-coagulation medication, history of bleeding disorder and those who do not complete the follow-up schedule will be excluded from the study.

研究组 & 干预措施

Compression

Active Comparator

Each patient will be randomized to receive compression of their nose on either the left or right for 5 continuous minutes after performing a lateral rhinotomy.

干预措施: Direct compression (Procedure)

No compression

No Intervention

Each patient will serve as their own control with the other side not receiving any compression after a lateral rhinotomy.

结局指标

主要结局

Periorbital edema and ecchymosis

时间窗: up to 4 weeks

The primary outcome of this study is periorbital edema and ecchymosis. Post-operative photographs will be graded by two staff Otolaryngologists and two senior Otolaryngology residents. Each evaluator will be presented a photograph of a patient and be asked to grade the degree of periorbital edema and ecchymosis for the left and right side. Previously published grading scales will be used. The evaluators will be blinded to the allocated side of nasal pressure and to the post-operative day of the photographs.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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