COVID-19 Endoscopy Survey (COVID-19 Endo)

May 19, 2020 updated by: Mohamed Alboraie, Al-Azhar University

Gastrointestinal Endoscopy in the Era of COVID-19: a Multinational Survey

A questionnaire containing some critical questions about practice inside GI endoscopy units 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 GI endoscopy practice in the studied countries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants has to answer the following questions:

  1. Participating center data:

    • Participant name (surname, first name): (optional)
    • Participant email: (optional)
    • Country: ……..
    • Working days (before COVID-19): ……..
    • Types of procedure performed /day (before COVID-19): …….
    • Number of endoscopists /day (before COVID-19): …….
    • Number of nursing staff /day (before COVID-19): …….
    • Number of administrative staff /day (before COVID-19): …….
    • Number of patients undergoing endoscopy/ day (before COVID-19): …….
    • Availability of negative pressure rooms (before COVID-19): …….
    • Number of endoscopy referrals/ day (before COVID-19): ……..

  2. Response to COVID-19:

    • Working days (after COVID-19): ……..
    • Types of procedure performed /day (after COVID-19): ……..
    • Number of endoscopists /day (after COVID-19): ……..
    • Number of nursing staff /day (after COVID-19): ……..
    • Number of administrative staff /day (after COVID-19): ……..
    • Do you consider teams (MD, RN, tech, anesthesia) that remain together for the entire day so as to compartmentalize and minimize personnel exposure?
    • Number of patients undergoing endoscopy/ day (after COVID-19): ……..
    • Number of endoscopy referrals/ day (after COVID-19): ……..
    • Availability of negative pressure rooms or use portable industrial-grade high-efficiency particulate air (HEPA) filters as a reasonable alternative: ……..
    • Which recommendations do you follow? WEO, AGA, BSG, APSDE, other
    • Applying triage for patients: e.g. FTOCC (APSDE); dose this include any tests
    • Do you use any of this for triage of patients: i) a telephone consultation with the referring provider or (ii) a telehealth visit with the patient or (iii) a multidisciplinary team approach or (virtual) disease/tumor board to facilitate decision-making for complicated patients.
    • Prioritization:

Which classification do you use for endoscopic procedures?

  1. urgent, semi-urgent and elective during COVID-19 outbreak

  2. Time sensitive procedure:

    • Time-sensitive procedures defined as procedures that if deferred may negatively impact patient-important outcomes. The decision to defer a procedure should be made on a case-by-case basis:

    • Time-Sensitive* (within 24 hours-8 weeks):

      1. Threat to the patient's life or Permanent dysfunction of an organ e.g. diagnosis and treatment of GI bleeding or cholangitis
      2. Risk of metastasis or progression of stage of disease e.g. e.g. work up of symptoms suggestive of cancer
      3. Risk of rapidly worsening progression of disease or severity of symptoms e.g. management decisions, such as treatment for IBD
    • Non-Time Sensitive: No short-term impact on patient-important outcomes e.g. screening or surveillance colonoscopy, follow up colonoscopy for +FIT
    • What are the most common clinical presentations? (please choose all that apply): Upper GI bleeding, lower GI bleeding, cholangitis, suspected cancer, foreign body, relive of GI obstruction, gastrostomy, other

  3. Endoscopy and use of PPE:

    • Did you receive appropriate education and training on infection control measures, including hand hygiene.
    • Did you receive adequate training on gowning and removal of PPE?
    • Do you practice Standard hand hygiene procedures before and after each case?
    • What type of personal protective equipment (PPE) do you usually use for doing an endoscopic procedure nowadays? (choose all that apply)

    Surgical mask N95 mask Isolation gown with water resistance Head cover Eye protection Face shield N95 protection in combination with face shield or surgical mask Other (please specify): ……..

    • Do you extend (over 8 hours) use of N95 masks?
    • Do you re-use of N95 masks?
    • Do you extend use (over 8 hours) any other equipment? : …..
    • Do you re use any other equipment? …..
    • If yes, please specify: …… If yes please specify: …..
    • Do you use of double gloves? ……

    • What PPE do you use for the following cases (choose all that apply)?

      1. Suspected cases of SARS-CoV-2 infection:

        Surgical mask N95 mask isolation gown with water resistance head cover eye protection face shield negative pressure room other please specify

      2. Probable cases of SARS-CoV-2 infection:

        Surgical mask N95 mask isolation gown with water resistance head cover eye protection face shield negative pressure room other please specify

      3. confirmed cases of SARS-CoV-2 infection: Surgical mask N95 mask isolation gown with water resistance head cover eye protection face shield negative pressure room other please specify

  4. Post endoscopy:

    • Do you motion in your report the status of the patients (suspected, probable, confirmed case of SARS-CoV-2 infection?
    • Do you use standard endoscopic decontamination or anything extra?
    • Do you give time for sterilizing endoscopy room after each suspected or confirmed case of SARS-CoV-2 infection? How long?
    • Do you call back your patients 2 weeks after procedure to ask them about symptoms/ diagnosis of SARS-CoV-2 infection?
    • Did you report any endoscopy related SARS-CoV-2 infection in your center (anytime for HCWs & up to two weeks after procedures for patients)?
    • Are you preparing a management plan for the waiting list after the current phase of the pandemic?

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11651
        • Al-Azhar Univerisity
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Faculty of medicine, Zagazig University
  • Iran, Islamic Republic of
      • Ahvaz, Iran, Islamic Republic of, 6155873559
        • Ahvaz Imam hospital
  • United States
    • New York
      • Albertson, New York, United States, 11507
        • Kings County Hospital Center, Brooklyn, NY, USA

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

- physicians working and practicing in gastrointestinal endoscopy units worldwide

Description

Inclusion Criteria:

  • physicians working in endoscopy units worldwide

Exclusion Criteria:

  • physicians not working in endoscopy units worldwide

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Practicing gastroenterologists
Practicing physicians performing gastrointestinal endoscpy
Other: Practice details
Physicians will report details of their endoscopy practice through answering the questions of the questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of GI societies recommendations on prevention of SARS-CoV-2 infection
Time Frame: 4- 6 months
To evaluate the validity of different GI societies recommendations applied locally and how effective they are in preventing transmission in endoscopy units through reporting any new cases developing COVID-19 within two weeks of doing endoscopy (whether a patient or health-care worker)
4- 6 months
To measure the percentage change in performed endoscopic procedure in response to COVID-19
Time Frame: 4- 6 months
To measure the percentage change in performed endoscopic procedure in response to COVID-19 in different centers of the world and the alternative solutions given to overcome this problem.
4- 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of COVID-19 precautions on procedure time
Time Frame: 4- 6 months
Effect of COVID-19 precautions on procedure time
4- 6 months
Effect of COVID-19 precautions on time of disinfection
Time Frame: 4- 6 months
Effect of COVID-19 precautions on prolongatIon of time of disinfection
4- 6 months
Effect of COVID-19 precautions on procedure success
Time Frame: 4- 6 months
Effect of COVID-19 precautions on the ability of the endoscopist to finish the procedure successfully
4- 6 months
Effect of COVID-19 precautions on complications
Time Frame: 4- 6 months
Effect of COVID-19 precautions on occurrence of complications
4- 6 months
Effect of COVID-19 precautions on working time
Time Frame: 4- 6 months
Effect of COVID-19 precautions on change of working time (prolongation or shortening)
4- 6 months
Effect of COVID-19 precautions on staff number
Time Frame: 4- 6 months
Effect of COVID-19 precautions on change of staff number
4- 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

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 Major Dates

Study Start (Actual)

April 10, 2020

Primary Completion (Actual)

April 25, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WES-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After publication we may share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 COVID-19

Clinical Trials on Practice details

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe