Intestines CancerNCT05694949
Main Postoperative Complications After COVID-19
An observational study of Intestines Cancer and Pulmonary Cancer, run by RenJi Hospital.
Trial summary
To explore the relationship between SARS-CoV-2 infection in different time before operation and postoperative main complications (mortality, main pulmonary and cardiovascular complications) 30 days after operation; To determine the best timing of surgery after SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestines Cancer, Pulmonary Cancer, Liver Cancer
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Feb 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients having elective or confine surgery in operating room
Who may be able to join
- Age≥18 years;
- Patients undergoing any type of elective or confine surgery in operating room;
- Informed consent.
Who cannot join
- Surgery under local anesthesia (without participation of anesthetist)
- Surgery outside the operating room, such as gastrointestinal endoscopy, puncture biopsy, etc
- Patients who cannot determine whether they have had SARS CoV-2 infection before surgery
- Participating in conflicting clinical study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Main Postoperative Complications After SARS-CoV-2 Infection: A Prospective Cohort Study
To explore the relationship between SARS-CoV-2 infection in different time before operation and postoperative main complications (mortality, main pulmonary and cardiovascular complications) 30 days after operation; To determine the best timing of surgery after SARS-CoV-2 infection.
- Conditions
- Intestines Cancer, Pulmonary Cancer, Liver Cancer, Trauma, Fractures, Bone
- Medical subject headings
- Intestinal Neoplasms, Lung Neoplasms, Liver Neoplasms, Wounds and Injuries, Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at 30 days after operation
All-cause mortality at 30 days after operation
Measured: 30 days after surgery
Secondary outcomes (2)
Main pulmonary complications at 30 days after operation
a composite of postoperative pneumonia, acute respiratory distress syndrome (ARDS) and unexpected ventilation
Measured: 30 days after surgery
Major Adverse Cardiovascular Events (MACE)
a composite of myocardial infarction, new-onset heart failure or cardiogenic shock, deep vein thrombosis (DVT), pulmonary embolism (PE), and cerebrovascular accident (CVA)
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestines CancerStudies of the same condition, open and under way.
- 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
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Chongqing Medical University, Sichuan Academy of Medical Sciences, Second Hospital of Shanxi Medical University
- Responsible party
- Sponsor
- Investigators
- Diansan Su, MD,PHD, Study chair, Renji Hospital, Shanghai Jiaotong University, School of Medcine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694949
- Sponsor's protocol ID
- MPOC-COVID-19
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Main Postoperative Complications After SARS-CoV-2 Infection: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05694949
- Acronym / sponsor ID
- MPOC-COVID-19
- Conditions
- Intestines Cancer, Pulmonary Cancer, Liver Cancer, Trauma, Fractures, Bone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Chongqing Medical University, Sichuan Academy of Medical Sciences, Second Hospital of Shanxi Medical University
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 23 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.
To explore the relationship between SARS-CoV-2 infection in different time before operation and postoperative main complications (mortality, main pulmonary and cardiovascular complications) 30 days after operation; To determine the best timing of surgery after SARS-CoV-2 infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients having elective or confine surgery in operating room
Key inclusion criteria (3 listed)
- Age≥18 years;
- Patients undergoing any type of elective or confine surgery in operating room;
- Informed consent.
Key exclusion criteria (4 listed)
- Surgery under local anesthesia (without participation of anesthetist)
- Surgery outside the operating room, such as gastrointestinal endoscopy, puncture biopsy, etc
- Patients who cannot determine whether they have had SARS CoV-2 infection before surgery
- Participating in conflicting clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality at 30 days after operation
Time frame: 30 days after surgery
All-cause mortality at 30 days after operation
2 secondary outcomes
Main pulmonary complications at 30 days after operation
Time frame: 30 days after surgery
Major Adverse Cardiovascular Events (MACE)
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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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.
Diansan Su, MD,PHD study chair
Renji Hospital, Shanghai Jiaotong University, School of Medcine
Questions about this trial
What is this clinical trial studying?
An observational study of Intestines Cancer and Pulmonary Cancer, run by RenJi 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 3 inclusion and 4 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 25 Jan 2023. 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 Diansan Su, MD,PHD (+8618616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at 30 days after operation (time frame: 30 days after surgery). 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 25 Jan 2023.