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临床试验/NCT06202573
NCT06202573已完成不适用

The Effect of the Number of Steps on Edema and Ecchymosis Due to Rhinoplasty Surgery

Istinye University3 个研究点 分布在 2 个国家目标入组 124 人开始时间: 2024年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
3
主要终点
Effect of Step Count on Edema After Rhinoplasty

研究概览

简要总结

Rhinoplasty surgery is being performed in increasing numbers in our country and around the world. After rhinoplasty surgery, patients experience swelling and bruising (ecchymosis) in their eyes. Many methods have been used to reduce this edema and bruising. Some of these methods are surgical techniques, medications, and supportive treatments used during and after surgery. (cortisol, vitamins, ice applications, etc.) When the literature is examined, there is currently no consensus on methods that reduce swelling and bruising. Again, in meta-analysis studies, there is no prominent or definitive method for reducing bruising and swelling. In our clinical observations, it has been observed that edema and bruising are significantly less common in tourists coming to our country from abroad. The idea that the reason for this may be that tourists walk a lot when they come to Istanbul, they want to travel a lot and see new places, has emerged as a hypothesis in our minds. The relationship between the number of steps taken during the day and postoperative edema-ecchymosis has not been examined before in the literature. In this respect, we think that our study will contribute to the literature.

详细描述

Edema and ecchymosis occurring in the eyes and face after rhinoplasty surgery greatly reduce the quality of life of patients. Many studies have been conducted in the literature to reduce this edema and ecchymosis. However, there is currently no successful method in the literature. Our aim in our study is to mobilize patients early after surgery and to investigate the effect of the number of steps they take after surgery on edema and attachment. For this purpose, 5 cohort groups will be created from patients who underwent rhinoplasty surgery by the same doctor. Patients will be randomly assigned to groups. The study was planned as a prospective, non-randomized, controlled study with parallel groups. Consecutive patients undergoing primary open septorhinoplasty were allocated to one of five predefined postoperative management groups in a fixed sequential rotation according to the order of surgery. Allocation was sequential and non-random. Outcome assessment was performed by an independent assessor blinded to group allocation.

Group A: patients who have a step counter and whom we do not motivate to walk Group B: control group patients with and without step counters Group C: patients who have a step counter and whom we motivate to take at least 5000 steps Group D: patients with step counters, whom we motivated to take at least 10000 steps Group E: patients who have a step counter, who do not motivate us to walk, and who will apply ice only on the 1st day after surgery

Criteria for inclusion in the study: Having primary septorhinoplasty surgery under general anesthesia, being between the ages of 18-40, being the surgery patient of 1 researcher doctors (Dr. Salih Aydın).

Criteria for inclusion in the study: revision septorhinoplasty surgery, patients with a chronic diagnosed disease such as diabetes, surgeries performed with conventional osteotomy, and surgeries without osteotomy. Measurements made with smartwatches other than the Xiaomi Band 5

The information of the patients participating in the study will be recorded on the forms. In this form: age, gender, accompanying diseases, smoking, drug use, occupation, doctor performing the surgery, duration of surgery (between intubation and extubation), end time of the surgery, the time he started walking on the first day, the number of steps taken on the first day and for 9 days. The daily step count (new day recordings will start at midnight) will be recorded. Patients will be asked to take facial photographs in the morning and evening. These photographs will be evaluated and noted using the edema-ecchymosis scale by a blind investigator. "Xiaomi Mi Band 5 smart bracelet" will be used to determine the number of steps taken. These wristbands will be given to the patients by the doctor performing the surgery and will be taken back at the end of the study. In light of the data obtained, the effect of early postoperative mobilization and the number of steps on edema and ecchymosis will be revealed.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having primary septorhinoplasty surgery under general anesthesia, being between the ages of 18-40, being the surgery patient of Dr. Salih Aydın

排除标准

  • revision septorhinoplasty surgery, those with a chronic diagnosed disease such as concomitant diabetes, surgeries performed with conventional osteotomy, surgeries without osteotomy. Measurements made with smart watches other than Xiaomi band 5

结局指标

主要结局

Effect of Step Count on Edema After Rhinoplasty

时间窗: 6 months

prospective study

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Salih Aydın

Prof.Dr.

Istinye University

研究点 (3)

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