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2020-05-18
2020-07-01
2020-07-05
670
NCT04385147
Al-Azhar University
Al-Azhar University
OBSERVATIONAL
Advanced Endoscopy During COVID-19
In this study, investigators aim to explore the status of advanced endoscopy in different endoscopy units all over the world.
In this study, investigators aim to explore the status of advanced endoscopy (endoscopic retrograde cholangiopancreatography and endoscopic ultrasound on a global level) in different endoscopy units all over the world, to report the characteristics of patients presented to these units and their procedure details. evaluate the validity of different GI societies recommendations applied in different GI endoscopy units on the prevention of SARS-CoV-2 nosocomial transmission and the overall impact of this recommendations on the service provided by each GI unit. Target audience: - Physicians performing advanced gastrointestinal endoscopies in different countries. Objectives: * Primary objective: 1- To explore the status of advanced endoscopy (endoscopic retrograde cholangiopancreatography and endoscopic ultrasound on a global level) in different endoscopy units all over the world, to report the characteristics of patients presented to these units and their procedure details. * Secondary objectives: 1. Effect of COVID-19 precautions on procedure time, procedure success, complications and patient outcomes 2. Effect of COVID-19 on working time and staff number Process: A questionnaire containing advanced endoscopy procedure details in different countries will be distributed via emails. Responses will be collected in an online platform and data will be analyzed to reveal the effect of SARS-CoV-2 pandemic on different aspects of advanced endoscopy practice in the studied countries.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-05-11 | N/A | 2020-07-07 |
2020-05-11 | N/A | 2020-07-08 |
2020-05-12 | N/A | 2020-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : ERCP Patients who will have endoscopic retrograde cholangiopancreatography | OTHER: Endoscopic management according to standard of care
|
| : EUS Patients who will have endoscopic ultrasound | OTHER: Endoscopic management according to standard of care
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Age, gender, nationality | Investigators will report the baseline demographic data (age, gender, nationality) of all patients. | 3 months |
| Indication for procedure, status of SARS-CoV-2 infection | Investigators will report the baseline data clinical data (indication for procedure, status of SARS-CoV-2 infection) of all patients. | 3 months |
| Complete blood count and liver functions tests | Investigators will report the baseline laboratory data (complete blood count and liver functions tests) of all patients. | 3 months |
| procedure related complications | Investigators will report the procedure related complications. | 3 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Effect of COVID-19 precautions on procedure time | Investigators will report wether the precautions lead to increase timing of the procedure | 3 months |
| Effect of COVID-19 precautions on staff number | Investigators will report wether the precautions affected staff number (increased or decreased) | 3 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
