NCT04970849

Brief Summary

Performance of diagnostic or therapeutic endoscopic procedures in inflammatory bowel disease (IBD) patients can be challenging during a viral pandemic; the main concerns being the safety and protection of patients and health care providers (HCP). The aim of this study is to identify endoscopic practice patterns and outcomes of IBD and coronavirus disease 19 (COVID-19) with a worldwide survey of HCP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
Last Updated

July 21, 2021

Status Verified

April 1, 2020

Enrollment Period

Same day

First QC Date

July 15, 2021

Last Update Submit

July 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The influence of covid-19 pandemic on endoscopic practice by IBD endoscopist

    The incidence of scheduled IBD endoscopies were postponed or cancelled due to the pandemic.

    1 week

Secondary Outcomes (1)

  • The incidence of COVID19 in IBD patients who underwent endoscopy

    1 week

Study Arms (1)

one group that is IBD endoscopist who perform the endoscopy for IBD patients

Complete the questionnaire online

Other: observation

Interventions

IBD doctors who perform the endoscopy perform the questionnaire

Also known as: endoscopy with no drug
one group that is IBD endoscopist who perform the endoscopy for IBD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The content of survey included: The number of procedures, the indication of endoscopy, the number of patients with IBD diagnosed Covid-19, and the influence of the epidemic situation on the diagnosis and treatment of IBD.

You may qualify if:

  • Doctors who are involved in the endoscopic treatment of IBD patients;
  • The endoscopist reads and signs an informed consent online. -

You may not qualify if:

  • Doctors who are not involved in the endoscopic treatment of IBD patients
  • Doctors who need the help of an agent, a witness, or someone else who can not complete the questionnaire independently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital Zhejiang University School of Medicine

Zhengzhou, Hangzhou, 310000, China

Location

Related Publications (1)

  • Mao R, Liang J, Shen J, Ghosh S, Zhu LR, Yang H, Wu KC, Chen MH; Chinese Society of IBD, Chinese Elite IBD Union; Chinese IBD Quality Care Evaluation Center Committee. Implications of COVID-19 for patients with pre-existing digestive diseases. Lancet Gastroenterol Hepatol. 2020 May;5(5):425-427. doi: 10.1016/S2468-1253(20)30076-5. Epub 2020 Mar 11. No abstract available.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

ObservationEndoscopy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative TechniquesDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Yan Chen

    浙江大学医学院附属第二医院

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2021

First Posted

July 21, 2021

Study Start

July 15, 2021

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

July 21, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

The result of questionnaire can be shared

Shared Documents
STUDY PROTOCOL
Time Frame
now is available
Access Criteria
All the doctors

Locations