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临床试验/NCT04433312
NCT04433312Unknown不适用

Impact of Cancellation of Non-urgent Surgical Cases on Patients During the COVID-19 Pandemic

Mansoura University1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10,000
试验地点
1
主要终点
Quality of Life of the patients

研究概览

简要总结

A questionnaire is developed based on the literature and clinical experience. Initial testing will be performed on 20 patients. The first and second sectors include patient demographics and patient clinical diagnosis/scheduled surgery, respectively. The following sectors examine the process of delivering the cancellation/re-scheduling; care after cancellation and whether the procedure conducted elsewhere or not; and the impact of cancellation on patient health, career, and financial aspects.

详细描述

This study is a cross-sectional survey of patients who were scheduled for elective surgical procedures and their surgeries were cancelled or postponed during the first wave of COVID-19 pandemic. The survey consists of a semi-structured questionnaire that is provided in the English language. A subsequent translation in patients' own Language will be provided based on geographical distribution. The survey will be conducted online, via email, or via telephone call based on the available and best method of participation according to involved hospital. Participants will be aware of the nature of the study and informed that their participation will be voluntary. Collected data will be confidential and anonymous.

The questionnaire is developed based on a literature review and clinical experience. Initial testing of the questionnaire will be performed with 20 patients to assess the reliability and inter-rater variations. Ambiguous questions and questions with a high rate of "I do not know" the answer will be excluded. To ensure high compliance, the questionnaire included the least possible number of questions. The questionnaire consists of closed questions except for two open questions that explore patients' suggestions to decrease the insult of cancellation on his life.

After initial testing, the final questionnaire will be formulated. The first sector of the questionnaire includes patient demographics and baseline characteristics; the second sector is regarding patient clinical condition, diagnosis, and scheduled surgery. The following sector examines the process of delivering the cancellation to the patient and requirements for re-scheduling. Patients will be classified into satisfied or dissatisfied according to the responses in this sector. The following sector addresses the course of care after cancellation and whether the patient conducted the surgery elsewhere or not. The last sector explores the impact of cancellation on patient health, career, and financial aspects. The impact of cancellation on patients' life will be classified into negative/positive/neutral based on the answers to this sector.

Statistical analyses will be performed using SPSS v. 20. Data distribution will be tested for normality using the Kolmogorov-Smirnov test and the Shapiro-Wilk test. Categorical variables will be expressed as group percentages and will be compared for independent samples using the Chi-square test. Continuous data of the survey will be presented as medians with ranges or means and standard deviations. A comparison of continuous data will be compared for independent samples using the T-test or Mann-Whitney test according to the data distribution. Spearman correlation coefficient will be used for further assessment of the strength of the association between variables. The statistical significance level will be set at <0.05.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients their elective surgeries were cancelled or postponed due to COVID-19 pandemic

排除标准

  • Patients underwent surgery during COVID-19
  • Emergency Surgeries

结局指标

主要结局

Quality of Life of the patients

时间窗: During the COVID-19 pandemic 6 months (March-October 2020)

A questionnaire based on the literature review to access the quality of the life of the patients

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

Mostafa shalaby, MD, MSc, PhD

Dr

Mansoura University

研究点 (1)

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