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Clinical Trials/NCT04987645
NCT04987645
Enrolling By Invitation
Not Applicable

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

Memorial University of Newfoundland1 site in 1 country140 target enrollmentJune 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Water Assisted Colonoscopy
Sponsor
Memorial University of Newfoundland
Enrollment
140
Locations
1
Primary Endpoint
Cecal Intubation Rate
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 22, 2022
End Date
June 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria MacDonald

Medical Student

Memorial University of Newfoundland

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Cecal Intubation Rate

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

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

Secondary Outcomes

  • Time to transverse colon intubation(Time from the start of the colonoscopy until the trainee reaches the transverse colon.)
  • 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.)
  • Patient comfort(Recorded during the colonoscopy)
  • Polyp/adenoma detection rate(This will occur after all the procedures have been completed. Will take roughly 1-2 days to record the number of polpys/adenomas detected.)
  • Sedation dosage required(Duration of the colonoscopy)
  • Complications during the procedure(Any complications that take place within the time frame of the procedure will be recorded.)

Study Sites (1)

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