Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training

NCT ID: NCT04987645

Last Updated: 2023-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-22

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Water Assisted Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each participant would be randomly assigned to either water only or water and air insufflation on insertion via a computer-generated random number.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

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

Study Groups

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Water-Assisted Colonoscopy

If this intervention is chosen randomly, the trainee will use water only technique for insertion.

Group Type OTHER

Water-only infusion technique

Intervention Type PROCEDURE

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.

Water and Air Insufflation

If this intervention is chosen randomly, the trainee will use water and air insufflation technique for insertion.

Group Type OTHER

Water infusion and air insufflation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial University of Newfoundland

OTHER

Sponsor Role lead

Responsible Party

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Maria MacDonald

Medical Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 24890443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25493011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20593332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23652813 (View on PubMed)

Other Identifiers

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2021.161

Identifier Type: -

Identifier Source: org_study_id

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