Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training

Randomized Controlled Trial Comparing the Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Water Assisted Colonoscopy
• Intervention / Treatment: Procedure: Water-only infusion technique; Procedure: Water infusion and air insufflation

Detailed Description

In this trial, the investigators will offer participation in the study when patients present for their scheduled routine colonoscopy. The participants will be asked to give consent for the colonoscopy procedure and participation in the trial. After consent is obtained and information is taken from the participants, each participant would be randomly assigned to either water only or water and air insufflation on insertion via a computer-generated random number. All patients over the age of 18 presenting for their scheduled colonoscopy at either the Health Sciences Centre or St. Clare's Mercy Hospital in St. John's, Newfoundland, can participate in the study. The colonoscopy will then be done in the usual manner with appropriate sedation. Patients will then be debriefed regarding their colonoscopy following the procedure in recovery. At the completion of the data extraction above, all trainee participants will undergo a semi-structured exit interview with one of the study investigators.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Newfoundland and Labrador
    • St.John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Water-Assisted Colonoscopy; If this intervention is chosen randomly, the trainee will use water only technique for insertion.	Procedure: Water-only infusion technique; 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.
Other: Water and Air Insufflation; If this intervention is chosen randomly, the trainee will use water and air insufflation technique for insertion.	Procedure: Water infusion and air insufflation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to transverse colon intubation	The time it takes for the trainee to insert the colonoscope to intubate the transverse colon.	Time from the start of the colonoscopy until the trainee reaches the transverse colon.
Patient comfort	Nurse Assessed Patient Comfort Score will be used to assess patient comfort.	Recorded during the colonoscopy
Sedation dosage required	We will document how much sedation was required during the procedure. A standard dosage will be given to all patients at the start of the procedure. If more sedation was needed during the procedure, this will be recorded.	Duration of the colonoscopy
Semi-structured exit interview	At the completion of the data extraction, all trainee participants will undergo a semi-structured exit interview with one of the study investigators to assess their learning experience.	After the data extraction (five minutes to complete)
Rate of transverse colon intubation	The percentage of success in which the trainee advances the colonoscope to the transverse colon.	Time from colonoscope insertion to transverse colon intubation.
Polyp/adenoma detection rate	After the procedures are completed, a study investigator will review the Meditech records and record the number of polyps/adenomas detected for each case.	This will occur after all the procedures have been completed. Will take roughly 1-2 days to record the number of polpys/adenomas detected.
Complications during the procedure	Any complications during the procedure will be recorded.These include bleeding, perforation resulting in subsequent abdominal surgery, and an adverse reaction to any anaesthetics used during the procedure.	Any complications that take place within the time frame of the procedure will be recorded.

Collaborators and Investigators

• Sponsor: Memorial University of Newfoundland

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021.161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No