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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04987645
Enrollment
140
Registered
2021-08-03
Start date
2022-06-22
Completion date
2024-06-30
Last updated
2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Water Assisted Colonoscopy

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.

Interventions

PROCEDUREWater-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.

PROCEDUREWater 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.

Sponsors

Memorial University of Newfoundland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

The participant will be blinded to the intervention until after the pain score has been completed.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Cecal Intubation RateCecal intubation rate with a 12-15 minute time limit before staff takes overThe percentage of success in which the trainee advances the colonoscope to the cecum.

Secondary

MeasureTime frameDescription
Patient comfortRecorded during the colonoscopyNurse Assessed Patient Comfort Score will be used to assess patient comfort.
Sedation dosage requiredDuration of the colonoscopyWe 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.
Semi-structured exit interviewAfter 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.
Time to transverse colon intubationTime 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.
Polyp/adenoma detection rateThis 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.
Complications during the procedureAny 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.
Rate of transverse colon intubationTime from colonoscope insertion to transverse colon intubation.The percentage of success in which the trainee advances the colonoscope to the transverse colon.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026