Same Day Bidirectional Endoscopies - Does the Sequence of Procedures or Choice of Insufflator Matter?

May 8, 2018 updated by: Dr. Lawrence Hookey, Queen's University

Upper endoscopies (Esophagogastroduodenoscopies-EGDs) as well as a lower endoscopies (Colonoscopies) are routinely performed by gastroenterologists to assess the lining of patients' upper and lower gastrointestinal tracts using a video endoscope (a long tube with a video camera on the end). An EGD is performed to examine the upper digestive tract to look for areas of inflammation, ulcerations, or other abnormalities in the swallowing tube, stomach, or duodenal lining. Similarly, a colonoscopy is performed to directly visualize the large bowel for polyps, inflammation, or other abnormalities in the lower bowel lining.

During these procedures, room air is routinely used to insufflate (expand/inflate the stomach and the colon) to allow for better viewing of the lining of the upper and lower gastrointestinal tracts; however, recently the use of carbon dioxide (CO2) (instead of air) has been shown to possibly have less post-procedure patient discomfort. Additionally, when both procedures are performed in the same day, it is currently unknown as to which sequence of procedures is better overall -whether to perform the EGD before colonoscopy or vice versa.

The overall aim of our research is to compare patients' comfort, total amount of sedation used, and overall satisfaction with the procedures between four randomly allocated groups, to see which method of insufflation and which procedural sequence is better when both procedures need to be performed in the same day. We hypothesize that in patients requiring same day endoscopies, performing an EGD prior to Colonoscopy with carbon dioxide (CO2) used as an insufflator is the best tolerated sequence associated with decreased sedation use and increased patient satisfaction/comfort.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Same day bi-directional endoscopies (EGD-esophagogastro-duodenoscopies and colonoscopies) are routinely performed in endoscopy units. Little however is known if the order of sequence of the two procedures (i.e. EGD (upper endoscopy) before colonoscopy (lower endoscopy) or vice-versa) is of any consequence. Those who favor performing EGDs prior to colonoscopies (EGD first approach) argue that the sedation necessary for EGD is then carried over to the colonoscopy and thus allows for a better tolerated colonoscopy. Additionally, abdominal bloating caused by insufflation of air during colonoscopy could lead to reduced tolerance of the subsequent EGD. Others however, argue that the gaseous distention of the small intestine caused by performing the EGD first leads to a more difficult and uncomfortable colonoscopy thereafter, likely due to a mechanical effect of air migrating to the proximal colon. Studies comparing procedural sequences in same day endoscopies have revealed conflicting results to date.

Some studies show that using the EGD first approach before allows for better procedural quality, decreased overall patient discomfort, less sedation, and a much higher chance of determining the diagnosis in the undifferentiated patient (e.g. occult GI bleeding). Other studies either show no difference in overall patient discomfort and satisfaction between both procedures, or even preference for colonoscopy before EGD. While some of these studies use moderate sedation, others use no sedation at all making generalization of these results difficult.

The use of carbon dioxide (CO2) for insufflation during upper and lower endoscopies has recently become popular over traditionally used room air, especially after studies revealed lesser post-procedure patient discomfort with the use of CO2. Whether its use affects the preferred sequence of procedures is still unknown.

Institutional variation across Canada regarding the sequence of procedures for same day bidirectional endoscopies is currently based on a combination of personal preferences and the few studies available. Given the absence of any formal guidelines in this area, we undertake the current study to test the hypothesis: In patients requiring same day bi-directional endoscopies, performing an EGD prior to Colonoscopy with carbon dioxide (CO2) used as an insufflator is the best tolerated sequence associated with decreased sedation use and increased patient satisfaction/comfort.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Hotel Dieu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • any patient with a clinical indication for receiving same day bi-directional endoscopies.

Exclusion Criteria:

  • prior bowel or gastrointestinal surgery(s) (exception: appendectomy, cholecystectomy, hernia repair)
  • known obstructive or cancerous lesions,
  • active inflammatory bowel disease,
  • hereditary polyposis syndromes,
  • allergies to fentanyl and/or midazolam (SOC endoscopy sedatives),
  • difficulties with communication or conditions affecting ability to provide informed consent,
  • neurologic conditions that affect breathing (e.g. GBS, ALS or myasthenia gravis),

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A1
EGD performed before the Colonoscopy with Carbon Dioxide insufflation.
Device: Carbon dioxide insufflation
using an automated carbon dioxide insufflator the gas will be infused on demand during the endoscopies
Procedure: EGD (Esophagogastroduodenoscopy) before Colonoscopy
the order of endoscopies will be randomized as well
Experimental: Group A2
EGD performed before the Colonoscopy with room air insufflation.
Procedure: EGD (Esophagogastroduodenoscopy) before Colonoscopy
the order of endoscopies will be randomized as well
Device: room air insufflation
using standard care room air will be infused on demand
Experimental: Group B1
Colonoscopy performed before the EGD with Carbon Dioxide insufflation.
Device: Carbon dioxide insufflation
using an automated carbon dioxide insufflator the gas will be infused on demand during the endoscopies
Procedure: Colonoscopy before EGD (Esophagogastroduodenoscopy)
Experimental: Group B2
Colonoscopy performed before the EGD with room air insufflation.
Device: room air insufflation
using standard care room air will be infused on demand
Procedure: Colonoscopy before EGD (Esophagogastroduodenoscopy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall patient satisfaction
Time Frame: Day 0 (post procedure)
Validated patient questionnaires administered to patients after both procedures are complete (on Day 0) followed by a recall interview via phone (on Day 7 after the procedures).
Day 0 (post procedure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sedation use
Time Frame: day 0 (day of procedure)
Total sedation calculated as a total cumulative dose administered.
day 0 (day of procedure)
patient comfort
Time Frame: day 0
Patient comfort assessed by the nurses during the procedures using previously validated assessment scales.
day 0
Patient satisfaction
Time Frame: Day 7
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Study Director: Lawrence Hookey, MD, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimate)

December 18, 2015

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bidirectional endoscopy study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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