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Combined Simultaneous EGD-colonoscopy Trial (CoSi Endoscopy)

NCT04473456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2020-12-08

No results posted yet for this study

Summary

The COVID -19 pandemic has reduced endoscopy services to an average of 83% producing a significant economic impact on endoscopy units worldwide. Endoscopy as an aerosol-generating procedure requires endoscopy units to allow 12 cycles of air exchange per hour, equivalent to 20 minutes, between patients, to reduce medical risk exposure. Planning strategies to facilitate economic reactivation of endoscopy services in a responsible manner, maintaining adequate security measures for both patients and healthcare personnel is currently a major challenge. Serial endoscopic interventions as esophagogastroduodenoscopy (EGD) and colonoscopy are commonly performed during the same sedation time. Estimated times for quality inspection in the upper digestive tract and the colon, are 7 and 6 minutes, respectively. In addition, time to reach the cecum and to set up the following procedure increase not only procedure time but SARS-CoV-2 exposure to healthcare personnel. Performing these two procedures simultaneously by two endoscopists would considerably reduce procedure time while increasing the number of patients evaluated in one day, especially in the period of service reactivation. There are no studies comparing simultaneous EGD and colonoscopy procedures and, serial procedures. This study aims to determine differences in procedures times between simultaneous EGD-colonoscopy and conventional serial EGD-colonoscopy as an alternative to improve the number of procedures/hour/unit during the COVID-19 era.

Conditions

  • Procedure Time

Interventions

PROCEDURE

Simultaneous EGD and colonoscopy

Patients are examined simultaneously by EGD and colonoscopy

Sponsors & Collaborators

  • Universidad de la Sabana

    collaborator OTHER

  • EmuraCenter LatinoAmerica

    lead NETWORK

Principal Investigators

  • FABIAN EMURA, PhD · EmuraCenter LatinoAmerica

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-13
Primary Completion
2020-09-22
Completion
2020-09-23

Countries

  • Colombia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04473456 on ClinicalTrials.gov