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

Sponsor
Changhai Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05682898
Collaborator
(none)
300
16.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Timing of colorectal cancer surgery

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Perioperative Management of Colorectal Cancer Patients Infected With COVID-19: a Multicenter Prospective Cohort Study.
Anticipated Study Start Date :
Jan 15, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of surgical complications [30 days after surgery]

    Complications including: intraperitoneal hemorrhage, anastomotic leak, anastomotic bleeding, abdominal infection, pulmonary infection, chylous fistula, intestinal obstruction, et al.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Changhai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wei Zhang, Professor, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT05682898
Other Study ID Numbers:
  • WeiZhang
First Posted:
Jan 12, 2023
Last Update Posted:
Jan 12, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2023