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

NCT02635217 | Completed DMC

• 1 other identifier: Bidirectional endoscopy study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Colon Polyps

Keywords

Colonoscopy; Esophagogastroduodenoscopy; Patient satisfaction; Bidirectional endoscopies

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 0 (post procedure)

Secondary Outcomes (3)

• sedation use

  day 0 (day of procedure)

• patient comfort

  day 0

• Patient satisfaction

  Day 7

Study Arms (4)

Group A1

EXPERIMENTAL

EGD performed before the Colonoscopy with Carbon Dioxide insufflation.

Device: Carbon dioxide insufflation; Procedure: EGD (Esophagogastroduodenoscopy) before Colonoscopy

Group A2

EXPERIMENTAL

EGD performed before the Colonoscopy with room air insufflation.

Device: room air insufflation; Procedure: EGD (Esophagogastroduodenoscopy) before Colonoscopy

Group B1

EXPERIMENTAL

Colonoscopy performed before the EGD with Carbon Dioxide insufflation.

Device: Carbon dioxide insufflation; Procedure: Colonoscopy before EGD (Esophagogastroduodenoscopy)

Group B2

EXPERIMENTAL

Colonoscopy performed before the EGD with room air insufflation.

Device: room air insufflation; Procedure: Colonoscopy before EGD (Esophagogastroduodenoscopy)

Interventions

Carbon dioxide insufflation DEVICE

using an automated carbon dioxide insufflator the gas will be infused on demand during the endoscopies

Group A1; Group B1

room air insufflation DEVICE

using standard care room air will be infused on demand

Group A2; Group B2

EGD (Esophagogastroduodenoscopy) before Colonoscopy PROCEDURE

the order of endoscopies will be randomized as well

Group A1; Group A2

Colonoscopy before EGD (Esophagogastroduodenoscopy) PROCEDURE

Group B1; Group B2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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),

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

Related Publications (12)

• 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.

  PMID: 20546443 BACKGROUND

• 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.

  PMID: 1728127 BACKGROUND

• 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.

  PMID: 24100751 BACKGROUND

• 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.

  PMID: 23355152 BACKGROUND

• 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.

  PMID: 21615790 BACKGROUND

• Kavitha K, Bharathi R, et. al Same Day Dual Endoscopy: Does the Sequence Matter? Gastrointestinal Endoscopy (abstract) 63.5 (2006) AB 145.

  BACKGROUND

• 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.

  PMID: 25393051 BACKGROUND

• 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.

  PMID: 23012681 BACKGROUND

• 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.

  PMID: 23317691 BACKGROUND

• 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.

  PMID: 21814063 BACKGROUND

• 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.

  PMID: 10968848 BACKGROUND

• 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.

  PMID: 15044882 BACKGROUND

MeSH Terms

Conditions

Anemia; Colonic Polyps; Patient Satisfaction

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

• Lawrence Hookey, MD

  Queen's University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Medical Director Endoscopy Unit, Hotel Dieu Hospital

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 18, 2015
• Study Start: January 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 9, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)