search
Back to results

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

Primary Purpose

Anemia, Colon Polyps

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Carbon dioxide insufflation
room air insufflation
EGD (Esophagogastroduodenoscopy) before Colonoscopy
Colonoscopy before EGD (Esophagogastroduodenoscopy)
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Colonoscopy, Esophagogastroduodenoscopy, Patient satisfaction, Bidirectional endoscopies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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),

Sites / Locations

  • Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A1

Group A2

Group B1

Group B2

Arm Description

EGD performed before the Colonoscopy with Carbon Dioxide insufflation.

EGD performed before the Colonoscopy with room air insufflation.

Colonoscopy performed before the EGD with Carbon Dioxide insufflation.

Colonoscopy performed before the EGD with room air insufflation.

Outcomes

Primary Outcome Measures

Overall patient satisfaction
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).

Secondary Outcome Measures

sedation use
Total sedation calculated as a total cumulative dose administered.
patient comfort
Patient comfort assessed by the nurses during the procedures using previously validated assessment scales.
Patient satisfaction

Full Information

First Posted
December 14, 2015
Last Updated
May 8, 2018
Sponsor
Queen's University
search

1. Study Identification

Unique Protocol Identification Number
NCT02635217
Brief Title
Same Day Bidirectional Endoscopies - Does the Sequence of Procedures or Choice of Insufflator Matter?
Official Title
Same Day Bidirectional Endoscopies - Does the Sequence of Procedures or Choice of Insufflator Matter?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Colon Polyps
Keywords
Colonoscopy, Esophagogastroduodenoscopy, Patient satisfaction, Bidirectional endoscopies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A1
Arm Type
Experimental
Arm Description
EGD performed before the Colonoscopy with Carbon Dioxide insufflation.
Arm Title
Group A2
Arm Type
Experimental
Arm Description
EGD performed before the Colonoscopy with room air insufflation.
Arm Title
Group B1
Arm Type
Experimental
Arm Description
Colonoscopy performed before the EGD with Carbon Dioxide insufflation.
Arm Title
Group B2
Arm Type
Experimental
Arm Description
Colonoscopy performed before the EGD with room air insufflation.
Intervention Type
Device
Intervention Name(s)
Carbon dioxide insufflation
Intervention Description
using an automated carbon dioxide insufflator the gas will be infused on demand during the endoscopies
Intervention Type
Device
Intervention Name(s)
room air insufflation
Intervention Description
using standard care room air will be infused on demand
Intervention Type
Procedure
Intervention Name(s)
EGD (Esophagogastroduodenoscopy) before Colonoscopy
Intervention Description
the order of endoscopies will be randomized as well
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy before EGD (Esophagogastroduodenoscopy)
Primary Outcome Measure Information:
Title
Overall patient satisfaction
Description
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).
Time Frame
Day 0 (post procedure)
Secondary Outcome Measure Information:
Title
sedation use
Description
Total sedation calculated as a total cumulative dose administered.
Time Frame
day 0 (day of procedure)
Title
patient comfort
Description
Patient comfort assessed by the nurses during the procedures using previously validated assessment scales.
Time Frame
day 0
Title
Patient satisfaction
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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),
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Hookey, MD
Organizational Affiliation
Queen's University
Official's Role
Study Director
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20546443
Citation
Cho JH, Kim JH, Lee YC, Song SY, Lee SK. Comparison of procedural sequences in same-day bidirectional endoscopy without benzodiazepine and propofol sedation: starting at the bottom or the top. J Gastroenterol Hepatol. 2010 May;25(5):899-904. doi: 10.1111/j.1440-1746.2009.06157.x.
Results Reference
background
PubMed Identifier
1728127
Citation
Zuckerman G, Benitez J. A prospective study of bidirectional endoscopy (colonoscopy and upper endoscopy) in the evaluation of patients with occult gastrointestinal bleeding. Am J Gastroenterol. 1992 Jan;87(1):62-6.
Results Reference
background
PubMed Identifier
24100751
Citation
Carter D, Lahat A, Papageorgiou NP, Goldstein S, Eliakim R, Bardan E. Comparison of procedural sequence in same-day consecutive bidirectional endoscopy using moderate sedation: a prospective randomized study. J Clin Gastroenterol. 2014 Mar;48(3):236-40. doi: 10.1097/MCG.0b013e3182a87e5f.
Results Reference
background
PubMed Identifier
23355152
Citation
Choi JS, Youn YH, Lee SK, Choi JY, Kim HM, Kim YJ, Han KJ, Cho HG, Song SY, Cho JH. Which should go first during same-day upper and lower gastrointestinal endoscopy? A randomized prospective study focusing on colonoscopy performance. Surg Endosc. 2013 Jun;27(6):2209-15. doi: 10.1007/s00464-012-2741-2. Epub 2013 Jan 26.
Results Reference
background
PubMed Identifier
21615790
Citation
Hsieh YH, Lin HJ, Tseng KC. Which should go first during same-day bidirectional endosocopy with propofol sedation? J Gastroenterol Hepatol. 2011 Oct;26(10):1559-64. doi: 10.1111/j.1440-1746.2011.06786.x.
Results Reference
background
Citation
Kavitha K, Bharathi R, et. al Same Day Dual Endoscopy: Does the Sequence Matter? Gastrointestinal Endoscopy (abstract) 63.5 (2006) AB 145.
Results Reference
background
PubMed Identifier
25393051
Citation
Sajid MS, Caswell J, Bhatti MI, Sains P, Baig MK, Miles WF. Carbon dioxide insufflation vs conventional air insufflation for colonoscopy: a systematic review and meta-analysis of published randomized controlled trials. Colorectal Dis. 2015 Feb;17(2):111-23. doi: 10.1111/codi.12837.
Results Reference
background
PubMed Identifier
23012681
Citation
Kurien M, Din S, Dear KL, Elphick DA. Same day bidirectional endoscopy - does the procedural order matter? J Gastrointestin Liver Dis. 2012 Sep;21(3):328. No abstract available.
Results Reference
background
PubMed Identifier
23317691
Citation
Rostom A, Ross ED, Dube C, Rutter MD, Lee T, Valori R, Bridges RJ, Pontifex D, Webbink V, Rees C, Brown C, Whetter DH, Kelsey SG, Hilsden RJ. Development and validation of a nurse-assessed patient comfort score for colonoscopy. Gastrointest Endosc. 2013 Feb;77(2):255-61. doi: 10.1016/j.gie.2012.10.003.
Results Reference
background
PubMed Identifier
21814063
Citation
Munson GW, Van Norstrand MD, O'donnell JJ, Hammes NL, Francis DL. Intraprocedural evaluation of comfort for sedated outpatient upper endoscopy and colonoscopy: the La Crosse (WI) intra-endoscopy sedation comfort score. Gastroenterol Nurs. 2011 Jul-Aug;34(4):296-301. doi: 10.1097/SGA.0b013e3182248777.
Results Reference
background
PubMed Identifier
10968848
Citation
Aronchick CA, Lipshutz WH, Wright SH, Dufrayne F, Bergman G. A novel tableted purgative for colonoscopic preparation: efficacy and safety comparisons with Colyte and Fleet Phospho-Soda. Gastrointest Endosc. 2000 Sep;52(3):346-52. doi: 10.1067/mge.2000.108480.
Results Reference
background
PubMed Identifier
15044882
Citation
Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc. 2004 Apr;59(4):482-6. doi: 10.1016/s0016-5107(03)02875-x. Erratum In: Gastrointest Endosc. 2004 Aug;60(2):326.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs