Combined Simultaneous EGD-colonoscopy Trial (CoSi Endoscopy)

NCT04473456 | Completed DMC

• 1 other identifier: 2020-ECL-6-1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Combined simultaneous (CoSi) endoscopy; EGD; Colonoscopy

Outcome Measures

Primary Outcomes (16)

• Procedures time

  Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.

  Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.

• Interprocedure time

  Time elapsed in minutes between the end of the first procedure and the starting of the second procedure (only applies in serial arm)

  Time elapsed in minutes between the end of the first procedure and the starting of the second procedure (only applies in serial arm)

• Upper GI inspection time

  Time taken in minutes to inspect the entire upper GI mucosa according to the complete photodocumentation method proposed by Emura et al.

  Time taken in minutes to inspect the entire upper GI mucosa according to the complete photodocumentation method proposed by Emura et al.

• Colonoscopy withdrawal time

  Time elapsed in minutes between the cecum and the lower rectum used to inspect the colorectal mucosa

  Time elapsed in minutes between the cecum and the lower rectum used to inspect the colorectal mucosa

• Colonoscopy insertion time

  Time elapsed in minutes to reach the cecum

  Time elapsed in minutes to reach the cecum

• EGD time

  Time elapsed in minutes between the insertion of the gastroscope into the mouth and the extraction from the mouth

  Time elapsed in minutes between the insertion of the gastroscope into the mouth and the extraction from the mouth

• Colonoscopy time

  Time elapsed in minutes between the insertion of the colonoscope into the lower rectum and the extraction from the lower rectum

  Time elapsed in minutes between the insertion of the colonoscope into the lower rectum and the extraction from the lower rectum

• Propofol used in EGD

  Amount in mg of Propofol used during EGD

  Amount in mg of Propofol used during EGD

• Propofol used in colonoscopy

  Amount in mg of Propofol used during colonoscopy

  Amount in mg of Propofol used during colonoscopy

• Propofol used in EGD and colonoscopy

  Amount of Propofol in mg used fro procedures in the simultaneous arm.

  Amount of Propofol in mg used fro procedures in the simultaneous arm

• percutaneous pCO2

  Measurement of pCO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.

  Measurement of pCO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.

• percutaneous pO2

  Measurement of pO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.

  Measurement of pO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.

• Position change 1

  Change of patient's position during colonoscopy. Yes or No answer

  During colonoscopy

• Position change 2

  If occurred, how many times the position changed. Numerical variable.

  During olonoscopy

• Post procedure symptoms survey related to colonoscopy

  Nausea, drowsiness, and dizziness are scored by patients using a scale from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).

  20 minutes after the last procedure and after 24 hours

• Post procedure symptoms survey related to sedation

  Abdominal pain, bloating, and pharyngeal pain are scored by patients using a scale from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).

  20 minutes after the last procedure and after 24 hours

Study Arms (2)

Serial arm

NO INTERVENTION

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.

Simultaneous arm

ACTIVE COMPARATOR

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.

Procedure: Simultaneous EGD and colonoscopy

Interventions

Simultaneous EGD and colonoscopy PROCEDURE

Patients are examined simultaneously by EGD and colonoscopy

Simultaneous arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• EmuraCenter LatinoAmerica: lead
• Universidad de la Sabana: collaborator

Study Sites (1)

EmuraCenter LatinoAmerica

Bogota, Cundinamarca, 110121, Colombia

Location

Related Publications (5)

• 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.

  PMID: 31529547 BACKGROUND

• 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.

  PMID: 32534934 BACKGROUND

• 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.

  PMID: 32569438 BACKGROUND

• 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.

  PMID: 27548885 BACKGROUND

• 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.

  PMID: 21607827 BACKGROUND

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• FABIAN EMURA, PhD

  EmuraCenter LatinoAmerica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, and outcomes evaluator are masked.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Patients are randomly assigned to non-intervention and intervention (simultaneous EGD and colonoscopy) arms

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: June 13, 2020
• Primary Completion: September 22, 2020
• Study Completion: September 23, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: December 1, 2020, for 1 month
• Access Criteria: free access

Locations

CO (1)