NCT05685914

Brief Summary

The goal of this observational study is to determine 30-day mortality and post endoscopic surgery complications in patients with COVID-19 infection who undergo endoscopic surgery.This results will inform future risk stratification, decision making and improve patient's clinical care.This study is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

January 12, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 9, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

January 12, 2023

Last Update Submit

May 5, 2023

Conditions

COVID-19Surgery-Complications

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    Death up to 30-days post surgery

    30 days

Secondary Outcomes (1)

  • postoperative complications

    30 days

Interventions

endoscopic surgeryPROCEDURE

Emergency or elective surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing endoscopic surgery done in an operating theatre by a surgeon.

You may qualify if:

  • Patients undergoing any type of endoscopic surgery in an operating theatre and these patients had COVID-19 infection either at the time of surgery or within 30 days of surgery.

You may not qualify if:

  • If COVID-19 infection is diagnosed \>30 days after discharge, the patient should not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, 100142, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Lin Chang

CONTACT

+86 01088196613changlin0730@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 17, 2023

Study Start

May 31, 2023

Primary Completion

June 30, 2023

Study Completion

August 31, 2023

Last Updated

May 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)