COVID-19NCT05685914
Outcomes of Endoscopic Operation in COVID-19 Infection: Cohort Study.
An observational study of COVID-19 and Surgery-Complications, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The goal of this observational study is to determine 30-day mortality and post endoscopic surgery complications in patients with COVID-19 infection who undergo endoscopic surgery.This results will inform future risk stratification, decision making and improve patient's clinical care.This study is an investigator-led… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19, Surgery-Complications
- What is being tested?
- endoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2023to 31 Aug 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing endoscopic surgery done in an operating theatre by a surgeon.
Who may be able to join
- Patients undergoing any type of endoscopic surgery in an operating theatre and these patients had COVID-19 infection either at the time of surgery or within 30 days of surgery.
Who cannot join
- If COVID-19 infection is diagnosed >30 days after discharge, the patient should not be included.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Cancer Hospital & Institute
Beijing, 100142
Lin Chang, +86 01088196613, changlin0730@126.com
About this study
The goal of this observational study is to determine 30-day mortality and post endoscopic surgery complications in patients with COVID-19 infection who undergo endoscopic surgery.This results will inform future risk stratification, decision making and improve patient's clinical care.This study is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk.
- Conditions
- COVID-19, Surgery-Complications
- Being tested
- endoscopic surgery
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic surgeryProcedure or surgery
Emergency or elective surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Death up to 30-days post surgery
Measured: 30 days
Secondary outcomes (1)
postoperative complications
Determine postoperative complications one month after surgery.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start31 May 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685914
- Sponsor's protocol ID
- qiwu
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Endoscopic Operation in COVID-19 Infection: Cohort Study.
- ClinicalTrials.gov ID
- NCT05685914
- Acronym / sponsor ID
- qiwu
- Conditions
- COVID-19, Surgery-Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 31 May 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 17 Jan 2023 (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.
The goal of this observational study is to determine 30-day mortality and post endoscopic surgery complications in patients with COVID-19 infection who undergo endoscopic surgery.This results will inform future risk stratification, decision making and improve patient's clinical care.This study is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing endoscopic surgery done in an operating theatre by a surgeon.
Key inclusion criteria (1 listed)
- Patients undergoing any type of endoscopic surgery in an operating theatre and these patients had COVID-19 infection either at the time of surgery or within 30 days of surgery.
Key exclusion criteria (1 listed)
- If COVID-19 infection is diagnosed >30 days after discharge, the patient should not be included.
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 |
|---|---|---|
| endoscopic surgeryEmergency or elective surgery | Procedure or surgery | – |
Primary outcome
30-day mortality
Time frame: 30 days
Death up to 30-days post surgery
1 secondary outcome
postoperative complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
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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.
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 COVID-19 and Surgery-Complications, run by Peking University Cancer Hospital & Institute 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Chang (+86 01088196613, changlin0730@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.