- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433312
Impact of Cancellation of Non-urgent Surgical Cases on Patients During the COVID-19 Pandemic
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Mansoura, Egypt, 35516
- Mansoura faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Both sex
- Patients their elective surgeries were cancelled or postponed due to COVID-19 pandemic
- World wide
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life of the patients
Time Frame: 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
|
During the COVID-19 pandemic 6 months (March-October 2020)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mostafa Shalaby, MD, MSc, PhD, Mansoura University
- Study Chair: Hosam Hamed, MD, MSc, PhD, Mansoura University
- Study Director: Ahmed M Elsheikh, MD,MBA,CMQOE, Mansoura University
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SURG RES COL 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaActive, not recruitingImprove Quality of LifeItaly
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Region VästmanlandUnknownHealth Related Quality of Life
Clinical Trials on Questionnaire
-
H. Lee Moffitt Cancer Center and Research InstituteSan Diego State University; University of Minnesota; University of ArizonaCompletedAnxiety | Psychological StressUnited States
-
Centre Hospitalier Universitaire de NiceCompletedGeneral Population | TDAH | Children Aged 5 to 18 YearsFrance
-
Imperial College LondonRoyal Marsden NHS Foundation Trust; University College London Hospitals; The... and other collaboratorsCompleted
-
Minneapolis Veterans Affairs Medical CenterUnited States Department of DefenseCompletedLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury)United States
-
NSABP Foundation IncNational Cancer Institute (NCI)Completed
-
Stanford UniversityRecruitingAstigmatism | Nearsightedness | FarsightednessUnited States
-
University of LiegeCompletedCritical Illness | Covid19 | Psychological Stress | FamilyBelgium
-
Rabin Medical CenterCompleted
-
Imperial College Healthcare NHS TrustNot yet recruitingCervical Myelopathy
-
National Taiwan University HospitalNational Taiwan UniversityUnknownComputerized Physician Order EntryTaiwan