NCT04401124

Brief Summary

This is a multi-centered, retrospective, observational study aimed at observing the current status of the management of gastrointestinal surgery during the COVID-19 pandemic, particularly the changes on surgery protocols and other key aspects of surgical workflow, so as to share experience with colleagues both domestic and abroad.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Status
unknown

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

First Submitted

Initial submission to the registry

May 22, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

May 25, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

6 days

First QC Date

May 22, 2020

Last Update Submit

May 22, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • treatment of fevers at arrival

    proportion of patients presented with fever, proportion of patients refered to fever clinics, proportion of patients screened for COVID-19, method of screening (CT? nucleated acid test?)

    1 day

  • treatment of post-operative fevers

    proportion of patients on whom fever occured, proportion of patients screened for COVID-19, method of screening (CT? nucleated acid test?)

    1 day

  • assorted surgical parameters

    Duration of operation (≥180min/\<180min); Intra-operative transfusion (Y/N); Surgical approach (Laparoscopy-involved/Open); Resection range (Non-radical/Radical); Lymph node dissection (Unknown/Not dissected/D1/D2 or above); Combined organ resection (Y/N); Post-operative complications (Y/N); Post-operative transfusion (Y/N); Post-operative hospital stay (≥7d/\<7d)

    1 day

Secondary Outcomes (1)

  • hospitals' protection measures and extent of implementation

    1 month

Study Arms (2)

patients treated at surgical emergency rooms

Other: no intervention

patients receiving surgeries (both elected and emergency)

Other: no intervention

Interventions

no intervention

patients receiving surgeries (both elected and emergency)patients treated at surgical emergency rooms

Eligibility Criteria

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

Patients at surgical ER, and patients in gastrointestinal wards

You may qualify if:

  • All patients arriving at surgical emergency and all patients receiving gastrointestinal surgeries in participating centers from 2020.1.1\~2020.3.31.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach NeoplasmsColorectal NeoplasmsGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesStomach DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Zhongtao Zhang, M.D.

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Pang, M.D.

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 22, 2020

First Posted

May 26, 2020

Study Start

May 25, 2020

Primary Completion

May 31, 2020

Study Completion

June 7, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05