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

January 11, 2023 updated by: Wei Zhang, Changhai Hospital
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Colorectal cancer patients undergoing surgery with perioperative COVID-19 infection.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WeiZhang

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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