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临床试验/NCT07063784
NCT07063784已完成不适用

Patient Positioning for Hand, Wrist, and Elbow Surgery: Stretcher Versus Operating Room Table, A Randomized Controlled Trial

Brett Lewellyn1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年8月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
The primary objective is to determine if there are increased or decreased complications when comparing patients who are having surgical procedures on an OR table vs a standard hospital stretcher.

研究概览

简要总结

The purpose of this study is to determine if there is any difference with regard to complication rates for performing surgery on an operating room (OR) table vs performing surgery on a stretcher with a hand table. The OR table and the stretcher with a hand table are the two types of operative surfaces the investigators will compare. The aim of this study is to compare surgeries of finger, hand, wrist, forearm, and elbow. The investigators will conduct the research at two outpatient surgery centers and an inpatient hospital center to see if operating room surface and time of surgery has any effect on complications after surgery. The investigators also will compare the costs of the two types of operative surfaces for the surgery.

详细描述

The primary objective is to determine if there is any difference with regard to complication rate for performing surgery on an OR table vs performing surgery on a stretcher with a hand table. Outcome measures will include any complications recorded by postoperative questionnaires filled out by patients, and examination of the data to see if there is any statistically significant (using P values) data.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria will involve skeletally mature adult patients who are to be operated on by the principal investigator, in a one year time frame, for any surgical procedure of the upper extremity from the fingertip to the middle portion of the arm above the elbow.

排除标准

  • Exclusion criteria will include: the skeletally immature, any patient with pre-existing neck pain, back pain, or decubitus ulcers; and patients with preexisting "pain" related or other conflicting medical issues: i.e. fibromyalgia; patients who were unable to respond for themselves in postop follow up i.e. dementia, Parkinson's disease, Alzheimer's and stroke.

结局指标

主要结局

The primary objective is to determine if there are increased or decreased complications when comparing patients who are having surgical procedures on an OR table vs a standard hospital stretcher.

时间窗: From enrollment to one year postoperative

次要结局

  • This will include determining any correlation between surgical time, length of follow up and complication rate according to surgical procedure and operating surface.(From enrollment to one year postoperative)

研究者

发起方
Brett Lewellyn
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Brett Lewellyn

Chief Hand & Upper Extremity Surgery

Orlando Health, Inc.

研究点 (1)

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