Gastric CancerNCT04401124
Status of Management of Surgery in Beijing During COVID-19
An observational study of Gastric Cancer and Colorectal Cancer, run by Beijing Friendship Hospital.
Trial summary
This is a multi-centered, retrospective, observational study aimed at observing the current status of the management of gastrointestinal surgery during the COVID-19 pandemic, particularly the changes on surgery protocols and other key aspects of surgical workflow, so as to share experience with colleagues both… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer, Colorectal Cancer, Gastrointestinal Disease
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2020to 7 Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at surgical ER, and patients in gastrointestinal wards
Who may be able to join
- All patients arriving at surgical emergency and all patients receiving gastrointestinal surgeries in participating centers from 2020.1.1~2020.3.31.
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Descriptive Study on the Proper Management of Gastrointestinal Surgeries During the COVID-19 Pandemic, With an Emphasis on the Alteration of Surgical Protocol and Workflow
This is a multi-centered, retrospective, observational study aimed at observing the current status of the management of gastrointestinal surgery during the COVID-19 pandemic, particularly the changes on surgery protocols and other key aspects of surgical workflow, so as to share experience with colleagues both domestic and abroad.
- Conditions
- Gastric Cancer, Colorectal Cancer, Gastrointestinal Disease
- Being tested
- no intervention
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| patients treated at surgical emergency rooms | Not described Receives: Other: no intervention | |
| patients receiving surgeries (both elected and emergency) | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment of fevers at arrival
proportion of patients presented with fever, proportion of patients refered to fever clinics, proportion of patients screened for COVID-19, method of screening (CT? nucleated acid test?)
Measured: 1 day
treatment of post-operative fevers
proportion of patients on whom fever occured, proportion of patients screened for COVID-19, method of screening (CT? nucleated acid test?)
Measured: 1 day
assorted surgical parameters
Duration of operation (≥180min/<180min); Intra-operative transfusion (Y/N); Surgical approach (Laparoscopy-involved/Open); Resection range (Non-radical/Radical); Lymph node dissection (Unknown/Not dissected/D1/D2 or above); Combined organ resection (Y/N); Post-operative complications (Y/N); Post-operative transfusion (Y/N); Post-operative hospital stay (≥7d/<7d)
Measured: 1 day
Secondary outcomes (1)
hospitals' protection measures and extent of implementation
Out-patient of surgery (Open/Closed); Emergency of surgery (Open/Closed); Fever clinic (Open/Closed); Surgical ward (Open/Closed); Functional level of surgical ward (Receive emergency surgery patients only/Receive surgery patients only/Receive all kinds of patients); Isolation ward for suspected COVID-19 patients (With/Without); Bed number in each surgical ward room (1/2/≥3); Isolation area within surgical ward (With/Without); Usage of sub-pressure operation theaters (Routinely applied/Applied for suspected patients/Never applied); Protection level of surgeons in surgical ward (No specific protection/Regular medical masks/Any of N95 mask, eye/face shields, gowns); Protection level of surgeons in ER room (No specific protection/Regular medical masks/Any of N95 mask, eye shields, face shields, gowns)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start25 May 2020 (estimated)
- Primary completion31 May 2020 (estimated)
- Study completion7 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Beijing Hospital, Xuanwu Hospital, Beijing, Peking Union Medical College Hospital, Beijing Chao Yang Hospital, Peking University Cancer Hospital & Institute, China-Japan Friendship Hospital, Peking University Shougang Hospital
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
- Investigators
- Zhongtao Zhang, M.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401124
- Sponsor's protocol ID
- BFH-SurgeryCovid
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study on the Proper Management of Gastrointestinal Surgeries During the COVID-19 Pandemic, With an Emphasis on the Alteration of Surgical Protocol and Workflow
- ClinicalTrials.gov ID
- NCT04401124
- Acronym / sponsor ID
- BFH-SurgeryCovid
- Conditions
- Gastric Cancer, Colorectal Cancer, Gastrointestinal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Beijing Hospital, Xuanwu Hospital, Beijing, Peking Union Medical College Hospital, Beijing Chao Yang Hospital, Peking University Cancer Hospital & Institute, China-Japan Friendship Hospital, Peking University Shougang Hospital
- Study start
- 25 May 2020 (estimated)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 7 Jun 2020 (estimated)
- First posted
- 26 May 2020 (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.
This is a multi-centered, retrospective, observational study aimed at observing the current status of the management of gastrointestinal surgery during the COVID-19 pandemic, particularly the changes on surgery protocols and other key aspects of surgical workflow, so as to share experience with colleagues both domestic and abroad.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients treated at surgical emergency rooms | – | Other: no intervention |
| patients receiving surgeries (both elected and emergency) | – | Other: no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at surgical ER, and patients in gastrointestinal wards
Key inclusion criteria (1 listed)
- All patients arriving at surgical emergency and all patients receiving gastrointestinal surgeries in participating centers from 2020.1.1~2020.3.31.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| no interventionno intervention | Other | patients receiving surgeries (both elected and emergency), patients treated at surgical emergency rooms |
Primary outcome
treatment of fevers at arrival
Time frame: 1 day
proportion of patients presented with fever, proportion of patients refered to fever clinics, proportion of patients screened for COVID-19, method of screening (CT? nucleated acid test?)
treatment of post-operative fevers
Time frame: 1 day
proportion of patients on whom fever occured, proportion of patients screened for COVID-19, method of screening (CT? nucleated acid test?)
assorted surgical parameters
Time frame: 1 day
Duration of operation (≥180min/<180min); Intra-operative transfusion (Y/N); Surgical approach (Laparoscopy-involved/Open); Resection range (Non-radical/Radical); Lymph node dissection (Unknown/Not dissected/D1/D2 or above); Combined organ resection (Y/N); Post-operative complications (Y/N); Post-operative transfusion (Y/N); Post-operative hospital stay (≥7d/<7d)
1 secondary outcome
hospitals' protection measures and extent of implementation
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Zhongtao Zhang, M.D. principal investigator
Beijing Friendship Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Colorectal Cancer, run by Beijing Friendship Hospital.
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 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Kai Pang, M.D. (18811792819 ext. 18811792819, pang_kai@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment of fevers at arrival (time frame: 1 day). The study lists 3 primary outcomes in all. 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 27 May 2020.