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Combined Simultaneous EGD-colonoscopy Trial (CoSi Endoscopy)

NCT ID: NCT04473456

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-13

Study Completion Date

2020-09-23

Brief Summary

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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.

Detailed Description

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Study type:

This is a prospective controlled randomized study to determine differences in procedure times of simultaneous EGD-colonoscopy and serial EGD-colonoscopy. Patients are randomized into two groups: the serial group, where the EGD is performed first and thereafter the colonoscopy and, the simultaneous group, where the two procedures are performed at the same time, each by a trained gastroenterologist.

Patients:

Eligible patients are those consecutively scheduled for EGD and colonoscopy at EmuraCenter LatinoAmerica, Bogota DC, Colombia between June and August, 2020. Indications for procedures include among others abdominal pain, screening for digestive cancer, chronic anemia, digestive bleeding, and chronic diarrhea. Exclusion criteria are inadequate bowel preparation with Boston score with at least 1 point in any segment, residual gastric food, previous digestive system surgery, and refusal to participate. Patients and their accompanying person give written consent of the procedures and are asked to complete a telephone survey related to COVID-19 symptoms 1 day before the procedure and 30 minutes before the procedure.

Randomization:

Endoscopists participating in the study are experts endoscopists. In both groups, colonoscopies are performed by the same expert endoscopist. EGD in the serial group is performed by the attending endoscopist responsible for procedures that day.

Outcomes:

Variables to be compared between groups include unit entry's time, time to completion of both procedures, EGD time, EGD inspection time, colonoscopy time, time to teach the cecum, withdrawal time, inter-procedure time, unit's exit time, the dose of sedation agent and endoscopic findings. Oxygenation (pO2) and percutaneous pCo2 are evaluated 5 minutes before, 5, and 10 minutes during the procedure and 5 minutes after completing the last procedure. A trained physician or anesthesiologist will administrate sedation to patients using Propofol. Post-procedure symptoms will be assessed by written survey 30 minutes and 24 hours after the procedure. This survey evaluates 6 symptoms, 3 of which are related to sedation: Nausea, drowsiness, and dizziness. and, the other 3 symptoms are related to the endoscopic procedure: abdominal pain, bloating, and pharyngeal pain. Each of the 6 symptoms will be scored from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).

Patient position and location of endoscopy systems:

All patients are positioned in the left lateral decubitus position. For simultaneous procedures, the EGD tower is located to the left side and the colonoscopy tower at the right side of the bedside at the level patient's head.

EGD:

The systematic complete photodocumentation approach proposed by Emura et al will be carried out to inspect the upper GI tract mucosa using a Fuji 7000 video processor and a Fuji Lasereo EG-760 gastroscope. BLI-bright digital chromoendoscopy will be performed to observe the hypopharynx, the esophagus, and the esophagogastric junction and, the LCI mode for evaluation of the stomach and duodenal mucosa. Low CO2 insufflation will be used using the Fuji GW-100 insufflator.

Colonoscopy in the serial group:

A Fuji Lasereo 7000 equipment and an EC-760ZP-V / L colonoscope will be used. The CO2 insufflation will be carried out with Fuji GW-100 equipment.

Colonoscopy in the parallel-group:

An Olympus Evis Exera II equipment and an H-180-AI colonoscope will be used. An Olympus UCR insufflator will be used for CO2 insufflation.

Transcutaneous measurement of pCo2:

The pCO2 measurements will be performed using a Tosca TCM kit (XLab Solutions). This equipment uses a transducer (ts sensor 54) that is positioned on the patient's arm and measures pCO2 non-invasively.

Conditions

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Procedure Time

Keywords

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Combined simultaneous (CoSi) endoscopy EGD Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomly assigned to non-intervention and intervention (simultaneous EGD and colonoscopy) arms
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Participants, care providers, and outcomes evaluator are masked.

Study Groups

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Serial arm

In the serial group, all colonoscopies will be performed by the same endoscopist. EGDs are performed by the attending endoscopist on the day of the procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Simultaneous arm

In the simultaneous group, all colonoscopies will be performed by the same endoscopist. EGDs are performed by the attending endoscopist on the day of the procedure.

Group Type ACTIVE_COMPARATOR

Simultaneous EGD and colonoscopy

Intervention Type PROCEDURE

Patients are examined simultaneously by EGD and colonoscopy

Interventions

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Simultaneous EGD and colonoscopy

Patients are examined simultaneously by EGD and colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Eligible patients are those scheduled for EGD and colonoscopy at EmuraCenter Latinoamerica, Bogota DC, Colombia between June and August 2020. Procedure indications: abdominal pain, chronic anemia, chronic diarrhea, cancer screening, gastrointestinal bleeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de la Sabana

OTHER

Sponsor Role collaborator

EmuraCenter LatinoAmerica

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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FABIAN EMURA, PhD

Role: PRINCIPAL_INVESTIGATOR

EmuraCenter LatinoAmerica

Locations

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EmuraCenter LatinoAmerica

Bogota, Cundinamarca, Colombia

Site Status

Countries

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Colombia

References

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Emura F, Sharma P, Arantes V, Cerisoli C, Parra-Blanco A, Sumiyama K, Araya R, Sobrino S, Chiu P, Matsuda K, Gonzalez R, Fujishiro M, Tajiri H. Principles and practice to facilitate complete photodocumentation of the upper gastrointestinal tract: World Endoscopy Organization position statement. Dig Endosc. 2020 Jan;32(2):168-179. doi: 10.1111/den.13530. Epub 2019 Nov 6.

Reference Type BACKGROUND
PMID: 31529547 (View on PubMed)

Parasa S, Reddy N, Faigel DO, Repici A, Emura F, Sharma P. Global Impact of the COVID-19 Pandemic on Endoscopy: An International Survey of 252 Centers From 55 Countries. Gastroenterology. 2020 Oct;159(4):1579-1581.e5. doi: 10.1053/j.gastro.2020.06.009. Epub 2020 Jun 11. No abstract available.

Reference Type BACKGROUND
PMID: 32534934 (View on PubMed)

Guda NM, Emura F, Reddy DN, Rey JF, Seo DW, Gyokeres T, Tajiri H, Faigel D. Recommendations for the Operation of Endoscopy Centers in the setting of the COVID-19 pandemic - World Endoscopy Organization guidance document. Dig Endosc. 2020 Sep;32(6):844-850. doi: 10.1111/den.13777. Epub 2020 Aug 12.

Reference Type BACKGROUND
PMID: 32569438 (View on PubMed)

Bisschops R, Areia M, Coron E, Dobru D, Kaskas B, Kuvaev R, Pech O, Ragunath K, Weusten B, Familiari P, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Senore C, Dinis-Ribeiro M, Rutter MD. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2016 Sep;48(9):843-64. doi: 10.1055/s-0042-113128. Epub 2016 Aug 22. No abstract available.

Reference Type BACKGROUND
PMID: 27548885 (View on PubMed)

Trencheva K, Dhar P, Sonoda T, Lee S, Samuels J, Stein B, Milsom J. Physiologic effects of simultaneous carbon dioxide insufflation by laparoscopy and colonoscopy: prospective evaluation. Surg Endosc. 2011 Oct;25(10):3279-85. doi: 10.1007/s00464-011-1705-2. Epub 2011 May 24.

Reference Type BACKGROUND
PMID: 21607827 (View on PubMed)

Other Identifiers

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2020-ECL-6-1

Identifier Type: -

Identifier Source: org_study_id