Colorectal CancerNCT05682898
Perioperative Management of Colorectal Cancer Patients Infected With COVID-19: a Multicenter Prospective Cohort Study.
An observational study of Colorectal Cancer and Surgical Procedure, Unspecified, run by Changhai Hospital.
Trial summary
This trial is a multicenter prospective cohort study to explore timing of colorectal cancer surgery after COVID-19 infection so that can assist clinicians and patients. Currently, there is less evidence on perioperative outcomes after COVID-19 vaccination and the omicron variant. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Surgical Procedure, Unspecified
- What is being tested?
- Timing of colorectal cancer surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 1 Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Colorectal cancer patients undergoing surgery with perioperative COVID-19 infection.
Who may be able to join
- undergoing colorectal cancer surgery
- infected with COVID-19 but nucleic acid test result is negative
- the patients compliance is good
- signed the consents voluntarily
Who cannot join
- undergoing emergency surgery(intestinal obstruction, intestinal perforation, intestinal hemorrhage, et al.)
- The patients' situations which judged by situations is not suitable to participate in the clinical trial
About this study
This trial is a multicenter prospective cohort study to explore timing of colorectal cancer surgery after COVID-19 infection so that can assist clinicians and patients. Currently, there is less evidence on perioperative outcomes after COVID-19 vaccination and the omicron variant. Therefore, it is necessary to update previously published consensus which recommends that patients should avoid elective surgery within 7 weeks of COVID-19 infection remain, unless the benefits of doing so exceed the risk of waiting. Aiming at the above problems, we plan to carry out a multicenter prospective cohort study to develop perioperative management according patients' different conditions.
- Conditions
- Colorectal Cancer, Surgical Procedure, Unspecified
- Being tested
- Timing of colorectal cancer surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of colorectal cancer surgeryProcedure or surgery
The timing of colorectal cancer surgery is different according patients' different conditions which is difined as more than 7 weeks or less than 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| More than 7 weeks | Timing of colorectal cancer surgery is more than 7 weeks after confirmed COVID-19 infection by COVID-19 nucleic acid test. Receives: Procedure: Timing of colorectal cancer surgery | |
| Less than 7 weeks | Timing of colorectal cancer surgery is less than 7 weeks after confirmed COVID-19 infection by COVID-19 nucleic acid test. Receives: Procedure: Timing of colorectal cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical complications
Complications including: intraperitoneal hemorrhage, anastomotic leak, anastomotic bleeding, abdominal infection, pulmonary infection, chylous fistula, intestinal obstruction, et al.
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 posted12 Jan 2023
- Study start15 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682898
- Sponsor's protocol ID
- WeiZhang
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 12 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 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Management of Colorectal Cancer Patients Infected With COVID-19: a Multicenter Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05682898
- Acronym / sponsor ID
- WeiZhang
- Conditions
- Colorectal Cancer, Surgical Procedure, Unspecified
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 12 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.
This trial is a multicenter prospective cohort study to explore timing of colorectal cancer surgery after COVID-19 infection so that can assist clinicians and patients. Currently, there is less evidence on perioperative outcomes after COVID-19 vaccination and the omicron variant. Therefore, it is necessary to update previously published consensus which recommends that patients should avoid elective surgery within 7 weeks of COVID-19 infection remain, unless the benefits of doing so exceed the risk of waiting. Aiming at the above problems, we plan to carry out a multicenter prospective cohort study to develop perioperative management according patients' different conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| More than 7 weeks | – | Procedure: Timing of colorectal cancer surgeryTiming of colorectal cancer surgery is more than 7 weeks after confirmed COVID-19 infection by COVID-19 nucleic acid test. |
| Less than 7 weeks | – | Procedure: Timing of colorectal cancer surgeryTiming of colorectal cancer surgery is less than 7 weeks after confirmed COVID-19 infection by COVID-19 nucleic acid test. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Colorectal cancer patients undergoing surgery with perioperative COVID-19 infection.
Key inclusion criteria (4 listed)
- undergoing colorectal cancer surgery
- infected with COVID-19 but nucleic acid test result is negative
- the patients compliance is good
- signed the consents voluntarily
Key exclusion criteria (2 listed)
- undergoing emergency surgery(intestinal obstruction, intestinal perforation, intestinal hemorrhage, et al.)
- The patients' situations which judged by situations is not suitable to participate in the clinical trial
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 |
|---|---|---|
| Timing of colorectal cancer surgeryThe timing of colorectal cancer surgery is different according patients' different conditions which is difined as more than 7 weeks or less than 7 weeks. | Procedure or surgery | Less than 7 weeks, More than 7 weeks |
Primary outcome
Incidence of surgical complications
Time frame: 30 days after surgery
Complications including: intraperitoneal hemorrhage, anastomotic leak, anastomotic bleeding, abdominal infection, pulmonary infection, chylous fistula, intestinal obstruction, et al.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Surgical Procedure, Unspecified, run by Changhai 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 4 inclusion and 2 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 12 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?
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?
Incidence of surgical complications (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 12 Jan 2023.