Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training

Sponsor
Memorial University of Newfoundland (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04987645
Collaborator
(none)
140
1
2
5.3
26.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Water-only infusion technique
  • Procedure: Water infusion and air insufflation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant)
Masking Description:
The participant will be blinded to the intervention until after the pain score has been completed.
Primary Purpose:
Other
Official Title:
Randomized Controlled Trial Comparing the Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training
Actual Study Start Date :
Jun 22, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Cecal Intubation Rate [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 Outcome Measures

  1. Time to transverse colon intubation [Time from the start of the colonoscopy until the trainee reaches the transverse colon.]

    The time it takes for the trainee to insert the colonoscope to intubate the transverse colon.

  2. Patient comfort [Recorded during the colonoscopy]

    Nurse Assessed Patient Comfort Score will be used to assess patient comfort.

  3. Sedation dosage required [Duration of the colonoscopy]

    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.

  4. Semi-structured exit interview [After the data extraction (five minutes to complete)]

    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.

  5. Rate of transverse colon intubation [Time from colonoscope insertion to transverse colon intubation.]

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

  6. 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.]

    After the procedures are completed, a study investigator will review the Meditech records and record the number of polyps/adenomas detected for each case.

  7. Complications during the procedure [Any complications that take place within the time frame of the procedure will be recorded.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Health Sciences Centre St.John's Newfoundland and Labrador Canada A1B 3V6

Sponsors and Collaborators

  • Memorial University of Newfoundland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Maria MacDonald, Medical Student, Memorial University of Newfoundland
ClinicalTrials.gov Identifier:
NCT04987645
Other Study ID Numbers:
  • 2021.161
First Posted:
Aug 3, 2021
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 25, 2022