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NCT05682898 Clinical Trial

Perioperative Management of Colorectal Cancer Patients Infected With COVID-19: a Multicenter Prospective Cohort Study.

Colorectal Cancer Clinical Trial

Official title:
Perioperative Management of Colorectal Cancer Patients Infected With COVID-19: a Multicenter Prospective Cohort Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05682898
Other study ID # WeiZhang
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 15, 2023
Est. completion date June 1, 2024

Study information
Verified date January 2023
Source Changhai Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date June 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - undergoing colorectal cancer surgery - infected with COVID-19 but nucleic acid test result is negative - the patients compliance is good - signed the consents voluntarily Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Timing of colorectal cancer 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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Changhai Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of surgical complications Complications including: intraperitoneal hemorrhage, anastomotic leak, anastomotic bleeding, abdominal infection, pulmonary infection, chylous fistula, intestinal obstruction, et al. 30 days after surgery
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