Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training

NCT04987645 | Unknown

• 1 other identifier: 2021.161
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a randomized trial comparing the use of only water or water and air insufflation during colonoscopy insertion by trainees. This study will be looking at the impact that water-assisted colonoscopy has on resident learning. The investigators hypothesize that the use of water only compared to water and air will improve the learning experience for trainees.

Conditions

Water Assisted Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Cecal Intubation Rate

  The percentage of success in which the trainee advances the colonoscope to the cecum.

  Cecal intubation rate with a 12-15 minute time limit before staff takes over

Secondary Outcomes (7)

• Time to transverse colon intubation

  Time from the start of the colonoscopy until the trainee reaches the transverse colon.

• Patient comfort

  Recorded during the colonoscopy

• Sedation dosage required

  Duration of the colonoscopy

• Semi-structured exit interview

  After the data extraction (five minutes to complete)

• Rate of transverse colon intubation

  Time from colonoscope insertion to transverse colon intubation.

Study Arms (2)

Water-Assisted Colonoscopy

OTHER

If this intervention is chosen randomly, the trainee will use water only technique for insertion.

Procedure: Water-only infusion technique

Water and Air Insufflation

OTHER

If this intervention is chosen randomly, the trainee will use water and air insufflation technique for insertion.

Procedure: Water infusion and air insufflation

Interventions

Water-only infusion technique PROCEDURE

During a routine colonoscopy, a resident in the study will use water only infusion technique for this intervention. This intervention is used to look at the impact that water assisted colonoscopy has on resident learning.

Water-Assisted Colonoscopy

Water infusion and air insufflation PROCEDURE

During a routine colonoscopy, a resident in the study will use water infusion and air insufflation technique for this intervention. This intervention is used to look at the impact that water assisted colonoscopy has on resident learning.

Water and Air Insufflation

Eligibility Criteria

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

You may qualify if:

• All patients over the age of 18 presenting for their scheduled routine colonoscopy at either the Health Sciences Center or St. Clare's Mercy Hospital in St. John's, NL, can participate in the study.

You may not qualify if:

• Previous bowel resection, refusal to participate, inability to provide informed consent, known bowel obstruction, emergency colonoscopy. It will be noted if patients have had a previous hysterectomy, patient's age, BMI, gender, and quality of bowel preparation as these factors have been known to prolong cecal intubation.

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

Study Sites (1)

Health Sciences Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Related Publications (4)

• Hsieh YH, Koo M, Leung FW. A patient-blinded randomized, controlled trial comparing air insufflation, water immersion, and water exchange during minimally sedated colonoscopy. Am J Gastroenterol. 2014 Sep;109(9):1390-400. doi: 10.1038/ajg.2014.126. Epub 2014 Jun 3.

  PMID: 24890443 BACKGROUND

• Lee SH, Park YK, Lee DJ, Kim KM. Colonoscopy procedural skills and training for new beginners. World J Gastroenterol. 2014 Dec 7;20(45):16984-95. doi: 10.3748/wjg.v20.i45.16984.

  PMID: 25493011 BACKGROUND

• Leung CW, Kaltenbach T, Soetikno R, Wu KK, Leung FW, Friedland S. Water immersion versus standard colonoscopy insertion technique: randomized trial shows promise for minimal sedation. Endoscopy. 2010 Jul;42(7):557-63. doi: 10.1055/s-0029-1244231. Epub 2010 Jun 30.

  PMID: 20593332 BACKGROUND

• Hu D, Xu Y, Sun Y, Zhu Q. Water infusion versus air insufflation for colonoscopy: a meta-analysis of randomized controlled trials. Tech Coloproctol. 2013 Oct;17(5):487-96. doi: 10.1007/s10151-013-1023-x. Epub 2013 May 8.

  PMID: 23652813 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will be blinded to the intervention until after the pain score has been completed.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Student

Model Details: Each participant would be randomly assigned to either water only or water and air insufflation on insertion via a computer-generated random number.

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 3, 2021
• Study Start: June 22, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)