Inflammatory Bowel DiseasesNCT04970849
Survey Study About Endoscopy During COVID-19 Pandemic for IBD Doctors
An observational study of Inflammatory Bowel Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- observation
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2021to 15 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Doctors who are involved in the endoscopic treatment of IBD patients;
- The endoscopist reads and signs an informed consent online. -
Who cannot join
- 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.
- Other conditions that the researchers considered unsuitable for inclusion or influenced the participants'ability to complete the study.-
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital Zhejiang University School of Medicine
Zhengzhou, Hangzhou, 310000
About this study
Official title: Patterns of Endoscopy During COVID-19 Pandemic: a Global Survey of Interventional Inflammatory Bowel Disease Practice
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.
Read the detailed description
The 20-item survey questionnaire was sent to physician members of the American Society for Gastrointestinal Endoscopy Special Interest Group in Interventional IBD, Chinese IBD Society Endoscopy Interest Group, and the China Crohn's and Colitis Foundation. The data of the survey was collected and analyzed.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- observation
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
Also called endoscopy with no drug
IBD doctors who perform the endoscopy perform the questionnaire
| Study group | Role | What they receive |
|---|---|---|
| one group that is IBD endoscopist who perform the endoscopy for IBD patients | Complete the questionnaire online Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (1)
The incidence of COVID19 in IBD patients who underwent endoscopy
The percentage of IBD patients who underwent endoscopy since the outbreak was tested positive for COVID 19
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start15 Jul 2021
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Chen, Principal investigator, 浙江大学医学院附属第二医院
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970849
- Sponsor's protocol ID
- I2020001357
- Status last verified
- Apr 2020
- First submitted
- 15 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The result of questionnaire can be shared
Publications
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.
PubMed 32171057
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Endoscopy During COVID-19 Pandemic: a Global Survey of Interventional Inflammatory Bowel Disease Practice
- ClinicalTrials.gov ID
- NCT04970849
- Acronym / sponsor ID
- I2020001357
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The 20-item survey questionnaire was sent to physician members of the American Society for Gastrointestinal Endoscopy Special Interest Group in Interventional IBD, Chinese IBD Society Endoscopy Interest Group, and the China Crohn's and Colitis Foundation. The data of the survey was collected and analyzed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group that is IBD endoscopist who perform the endoscopy for IBD patients | – | Other: observationComplete the questionnaire online |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Doctors who are involved in the endoscopic treatment of IBD patients;
- The endoscopist reads and signs an informed consent online. -
Key exclusion criteria (3 listed)
- 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.
- Other conditions that the researchers considered unsuitable for inclusion or influenced the participants'ability to complete the study.-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationAlso: endoscopy with no drugIBD doctors who perform the endoscopy perform the questionnaire | Other | one group that is IBD endoscopist who perform the endoscopy for IBD patients |
Primary outcome
The influence of covid-19 pandemic on endoscopic practice by IBD endoscopist
Time frame: 1 week
The incidence of scheduled IBD endoscopies were postponed or cancelled due to the pandemic.
1 secondary outcome
The incidence of COVID19 in IBD patients who underwent endoscopy
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Results publication: PubMed 32171057Mao 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.
- Individual participant dataSharing planned: Yes. The result of questionnaire can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Chen principal investigator
浙江大学医学院附属第二医院
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influence of covid-19 pandemic on endoscopic practice by IBD endoscopist (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04970849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.