Clinical trial NCT04433312: Impact of Cancellation of Non-urgent Surgical Cases on Patients During the COVID-19 Pandemic
Official title: Impact of Cancellation of Non-urgent Surgical Cases on Patients During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Satisfaction, Patient
Quality of Life
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Both sex
* Patients their elective surgeries were cancelled or postponed due to COVID-19 pandemic
* World wide

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Both sex
* Patients their elective surgeries were cancelled or postponed due to COVID-19 pandemic

Exclusion Criteria:

* Patients underwent surgery during COVID-19
* Emergency Surgeries

Primary outcomes:
measure: Quality of Life of the patients
timeFrame: During the COVID-19 pandemic 6 months (March-October 2020)
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Faculty of Medicine
Study officials:
affiliation: Mansoura University
name: Mostafa Shalaby, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Hosam Hamed, MD, MSc, PhD
role: STUDY_CHAIR
affiliation: Mansoura University
name: Ahmed M Elsheikh, MD,MBA,CMQOE
role: STUDY_DIRECTOR
References: