Satisfaction, PatientNCT04433312
Impact of Cancellation of Non-urgent Surgical Cases on Patients During the COVID-19 Pandemic
An observational study of Satisfaction, Patient and Quality of Life, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Satisfaction, Patient, Quality of Life
- What is being tested?
- Questionnaire
- How many people
- 10,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 1 Dec 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: * Both sex * Patients their elective surgeries were cancelled or postponed due to COVID-19 pandemic * World wide
Who may be able to join
- Both sex
- Patients their elective surgeries were cancelled or postponed due to COVID-19 pandemic
Who cannot join
- Patients underwent surgery during COVID-19
- Emergency Surgeries
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura Faculty of Medicine
Al Mansurah, 35516
Mostafa Shalaby, MD, MSc, PhD, 00201001645917, mostafashalaby@mans.edu.eg
About this study
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.
Read the 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.
- Conditions
- Satisfaction, Patient, Quality of Life
- Being tested
- Questionnaire
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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. 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life of the patients
A questionnaire based on the literature review to access the quality of the life of the patients
Measured: During the COVID-19 pandemic 6 months (March-October 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PatientStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa shalaby, MD, MSc, PhD, Mansoura University
- Investigators
- Mostafa Shalaby, MD, MSc, PhD, Principal investigator, Mansoura UniversityHosam Hamed, MD, MSc, PhD, Study chair, Mansoura UniversityAhmed M Elsheikh, MD,MBA,CMQOE, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433312
- Sponsor's protocol ID
- SURG RES COL 2
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cancellation of Non-urgent Surgical Cases on Patients During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04433312
- Acronym / sponsor ID
- SURG RES COL 2
- Conditions
- Satisfaction, Patient, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- * Both sex * Patients their elective surgeries were cancelled or postponed due to COVID-19 pandemic * World wide
Key inclusion criteria (2 listed)
- Both sex
- Patients their elective surgeries were cancelled or postponed due to COVID-19 pandemic
Key exclusion criteria (2 listed)
- Patients underwent surgery during COVID-19
- Emergency Surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireThe 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. 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. | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa Shalaby, MD, MSc, PhD principal investigator
Mansoura University
Hosam Hamed, MD, MSc, PhD study chair
Mansoura University
Ahmed M Elsheikh, MD,MBA,CMQOE study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Satisfaction, Patient and Quality of Life, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa M Shalaby, MD, MSc, PhD (00201001645917, mostafashalaby@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life of the patients (time frame: During the COVID-19 pandemic 6 months (March-October 2020)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.