Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training

October 3, 2023 updated by: Maria MacDonald, Memorial University of Newfoundland

Randomized Controlled Trial Comparing the Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St.John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cecal Intubation Rate
Time Frame: 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.
Cecal intubation rate with a 12-15 minute time limit before staff takes over

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to transverse colon intubation
Time Frame: 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.
Time from the start of the colonoscopy until the trainee reaches the transverse colon.
Patient comfort
Time Frame: Recorded during the colonoscopy
Nurse Assessed Patient Comfort Score will be used to assess patient comfort.
Recorded during the colonoscopy
Sedation dosage required
Time Frame: 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.
Duration of the colonoscopy
Semi-structured exit interview
Time Frame: 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.
After the data extraction (five minutes to complete)
Rate of transverse colon intubation
Time Frame: Time from colonoscope insertion to transverse colon intubation.
The percentage of success in which the trainee advances the colonoscope to the transverse colon.
Time from colonoscope insertion to transverse colon intubation.
Polyp/adenoma detection rate
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.
After the procedures are completed, a study investigator will review the Meditech records and record the number of polyps/adenomas detected for each case.
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
Time Frame: 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.
Any complications that take place within the time frame of the procedure will be recorded.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial University of Newfoundland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021.161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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