NCT06638957

Brief Summary

The goal of this observational study is to assess the impact of the COVID-19 pandemic on colorectal cancer (CRC) outcomes, particularly focusing on stage distribution and recurrence-free survival in patients undergoing surgery at eight tertiary care institutions in Korea from 2018 to 2020. Main Question Does the COVID-19 pandemic lead to more advanced stages of colorectal cancer at diagnosis and higher complication rates during surgery? Is there a significant difference in recurrence-free survival between CRC patients treated before and during the pandemic? This study found that more patients presented with advanced-stage CRC during the COVID-19 pandemic, with significantly higher rates of tumor-related complications (perforations, abscesses, and preoperative obstructions), as well as an increase in open surgeries and combined resections. No significant difference in recurrence-free survival was observed between the pre-COVID-19 and COVID-19 periods, although postoperative complication rates were higher, especially among rectal cancer patients and those receiving preoperative chemoradiotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,951

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

October 7, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

colorectalcovidoncologic outcome

Outcome Measures

Primary Outcomes (1)

  • stage distribution in patients who underwent CRC surgery during the pre-COVID-19 period, compared with those who underwent the surgery during the COVID-19 period.

    We aimed to document the pathological stage for each patient based on the biopsy results after surgery and analyze how the stage distribution differed between the pre-COVID and COVID groups.

    At the time the biopsy results were available for patients who underwent surgery between 2018 and 2020 (7 days after surgery).

Secondary Outcomes (1)

  • 2-year recurrence free survival (RFS) and surgical complication rate in patients who underwent CRC surgery during the pre-COVID-19 period, compared with those who underwent the surgery during the COVID-19 period.

    Outcome measures will be assessed at 2 years post-surgery.

Study Arms (2)

patients with colorectal cancer who underwent surgical treatment from 2018 to 2020

The pre-COVID-19 period extended from 2018 to February 2020

patients with colorectal cancer who underwent surgical treatment from 2020

the COVID-19 period began in March 2020 to December 2020

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Between 2018 and 2020, 14951 patients underwent surgery for suspected CRC across the eight institutions.

You may qualify if:

  • Patients diagnosed with colorectal cancer who underwent surgery
  • in 8 institution including Asan Medical Center, Seoul St. Mary's Hospital, Korea University Anam Hospital, Samsung Medical Center, Pusan National University Yangsan Hospital, Gangnam Severance Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital

You may not qualify if:

  • Familial adenomatous polyposis (FAP)
  • Hereditary non-polyposis colon cancer (HNPCC)
  • Cancer associated with inflammatory bowel disease (IBD)
  • Colorectal cancer not proven on biopsy, and pathologies other than adenocarcinoma.
  • Emergency operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan medical center

Seoul, Songpa, 05505, South Korea

Location

MeSH Terms

Conditions

Colorectal NeoplasmsCOVID-19

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 15, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

September 20, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations