COVID-19 Endoscopy Survey

COVID-19 Clinical Trial

— COVID-19 Endo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342637
• Other study ID #: WES-2
• Status: Completed
• Start date: April 10, 2020
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: May 1, 2020
• Est. primary completion date: April 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• physicians working in endoscopy units worldwide

Exclusion Criteria:

• physicians not working in endoscopy units worldwide

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Practice details
Physicians will report details of their endoscopy practice through answering the questions of the questionnaire

Locations

Country	Name	City	State
Egypt	Al-Azhar Univerisity	Cairo
Egypt	Faculty of Medicine, Zagazig University	Zagazig	Sharkia
Iran, Islamic Republic of	Ahvaz Imam hospital	Ahvaz
United States	Kings County Hospital Center, Brooklyn, NY, USA	Albertson	New York

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Countries where clinical trial is conducted

United States,  Egypt,  Iran, Islamic Republic of, 

References & Publications (6)

Chiu PWY, Ng SC, Inoue H, Reddy DN, Ling Hu E, Cho JY, Ho LK, Hewett DG, Chiu HM, Rerknimitr R, Wang HP, Ho SH, Seo DW, Goh KL, Tajiri H, Kitano S, Chan FKL. Practice of endoscopy during COVID-19 pandemic: position statements of the Asian Pacific Society — View Citation

Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.20 — View Citation

Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Apr 11;395(10231):1225-1228. doi: 10.1016/S0140-6736(20)30627-9. Epub 2020 Mar 13. Review. — View Citation

Ruuskanen O, Lahti E, Jennings LC, Murdoch DR. Viral pneumonia. Lancet. 2011 Apr 9;377(9773):1264-75. doi: 10.1016/S0140-6736(10)61459-6. Epub 2011 Mar 22. Review. — View Citation

Sultan S, Lim JK, Altayar O, Davitkov P, Feuerstein JD, Siddique SM, Falck-Ytter Y, El-Serag HB; AGA. AGA Institute Rapid Recommendations for Gastrointestinal Procedures During the COVID-19 Pandemic. Gastroenterology. 2020 Mar 31. pii: S0016-5085(20)30458 — View Citation

Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of GI societies recommendations on prevention of SARS-CoV-2 infection	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
Primary	To measure the percentage change in performed endoscopic procedure in response to COVID-19	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	Effect of COVID-19 precautions on procedure time	Effect of COVID-19 precautions on procedure time	4- 6 months
Secondary	Effect of COVID-19 precautions on time of disinfection	Effect of COVID-19 precautions on prolongatIon of time of disinfection	4- 6 months
Secondary	Effect of COVID-19 precautions on procedure success	Effect of COVID-19 precautions on the ability of the endoscopist to finish the procedure successfully	4- 6 months
Secondary	Effect of COVID-19 precautions on complications	Effect of COVID-19 precautions on occurrence of complications	4- 6 months
Secondary	Effect of COVID-19 precautions on working time	Effect of COVID-19 precautions on change of working time (prolongation or shortening)	4- 6 months
Secondary	Effect of COVID-19 precautions on staff number	Effect of COVID-19 precautions on change of staff number	4- 6 months

External Links

•   WEO COVID-19 Response Taskforce. WEO Advice to Endoscopists. accessed April 7, 2020.
•   WHO: Coronavirus Disease 2019 (COVID-19): Situation Report--51. WHO website. Published March 11, 2020. Accessed April 6, 2020.