Clinical trial NCT04987645: Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training
Official title: Randomized Controlled Trial Comparing the Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Water Assisted Colonoscopy
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Cecal Intubation Rate
timeFrame: Cecal intubation rate with a 12-15 minute time limit before staff takes over
Secondary outcomes:
measure: Time to transverse colon intubation
timeFrame: Time from the start of the colonoscopy until the trainee reaches the transverse colon.
measure: Patient comfort
timeFrame: Recorded during the colonoscopy
measure: Sedation dosage required
timeFrame: Duration of the colonoscopy
measure: Semi-structured exit interview
timeFrame: After the data extraction (five minutes to complete)
measure: Rate of transverse colon intubation
timeFrame: Time from colonoscope insertion to transverse colon intubation.
measure: Polyp/adenoma detection rate
timeFrame: This will occur after all the procedures have been completed. Will take roughly 1-2 days to record the number of polpys/adenomas detected.
measure: Complications during the procedure
timeFrame: Any complications that take place within the time frame of the procedure will be recorded.
Other outcomes:
Locations:
city: St.John's
country: Canada
facility: Health Sciences Centre
state: Newfoundland and Labrador
Study officials:
References:
citation: Hsieh YH, Koo M, Leung FW. A patient-blinded randomized, controlled trial comparing air insufflation, water immersion, and water exchange during minimally sedated colonoscopy. Am J Gastroenterol. 2014 Sep;109(9):1390-400. doi: 10.1038/ajg.2014.126. Epub 2014 Jun 3.
citation: Lee SH, Park YK, Lee DJ, Kim KM. Colonoscopy procedural skills and training for new beginners. World J Gastroenterol. 2014 Dec 7;20(45):16984-95. doi: 10.3748/wjg.v20.i45.16984.
citation: Leung CW, Kaltenbach T, Soetikno R, Wu KK, Leung FW, Friedland S. Water immersion versus standard colonoscopy insertion technique: randomized trial shows promise for minimal sedation. Endoscopy. 2010 Jul;42(7):557-63. doi: 10.1055/s-0029-1244231. Epub 2010 Jun 30.
citation: Hu D, Xu Y, Sun Y, Zhu Q. Water infusion versus air insufflation for colonoscopy: a meta-analysis of randomized controlled trials. Tech Coloproctol. 2013 Oct;17(5):487-96. doi: 10.1007/s10151-013-1023-x. Epub 2013 May 8.