COVID-19 Endoscopy Survey

Completed

• Conditions: COVID-19
• Interventions: Other: Practice details

• Registration Number: NCT04342637
• Lead Sponsor: Al-Azhar University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-08
• Study Start: 2020-04-10
• Study First Posted: 2020-04-13
• Primary Completion: 2020-04-25
• Status Verified: 2020-05
• Study Completion: 2020-05-01
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

• physicians working in endoscopy units worldwide

Exclusion Criteria

• physicians not working in endoscopy units worldwide

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Practicing gastroenterologists	Practice details	Practicing physicians performing gastrointestinal endoscpy

Primary Outcome Measures

Name	Time	Method
Effect of GI societies recommendations on prevention of SARS-CoV-2 infection	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)
To measure the percentage change in performed endoscopic procedure in response to COVID-19	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.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Kings County Hospital Center, Brooklyn, NY, USA; 🇺🇸 Albertson, New York, United States

Al-Azhar Univerisity; 🇪🇬 Cairo, Egypt

Ahvaz Imam hospital; 🇮🇷 Ahvaz, Iran, Islamic Republic of

Faculty of Medicine, Zagazig University; 🇪🇬 Zagazig, Sharkia, Egypt