An interventional study of Water-only infusion technique and Water infusion and air insufflation in Water Assisted Colonoscopy, sponsored by Memorial University of Newfoundland. Enrolling by invitation at 1 site in Canada. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by Memorial University of Newfoundland · Not applicable, Interventional, and Other
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.
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.
Memorial University of Newfoundland is the lead sponsor of 49 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
If this intervention is chosen randomly, the trainee will use water only technique for insertion.
Procedure: Water-only infusion technique
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 only infusion technique for this intervention. This intervention is used to look at the impact that water assisted colonoscopy has on resident learning.
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.
Cecal Intubation Rate
The percentage of success in which the trainee advances the colonoscope to the cecum.
Time frame: Cecal intubation rate with a 12-15 minute time limit before staff takes over
Time to transverse colon intubation
The time it takes for the trainee to insert the colonoscope to intubate the transverse colon.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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.
Time frame: 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.
Time frame: Any complications that take place within the time frame of the procedure will be recorded.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Memorial University of Newfoundland