Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training

Study 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.

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

Conditions
-----------------
Water Assisted Colonoscopy

Intervention / Treatment
-----------------
* Procedure: Water-only infusion technique
* Procedure: Water infusion and air insufflation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each participant would be randomly assigned to either water only or water and air insufflation on insertion via a computer-generated random number.
Masking: Single


Arms and Interventions

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

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. |