Water Assisted ColonoscopyNCT04987645
Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training
A study testing Water-only infusion technique and Water infusion and air insufflation in people with Water Assisted Colonoscopy, run by Memorial University of Newfoundland at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Water Assisted Colonoscopy
- What is being tested?
- Water-only infusion technique and Water infusion and air insufflation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jun 2022to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B 3V6
About this study
Official title: 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.
Read the 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.
- Conditions
- Water Assisted Colonoscopy
- Being tested
- Water-only infusion technique, Water infusion and air insufflation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-only infusion techniqueProcedure or surgery
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 infusion and air insufflationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Water-Assisted Colonoscopy | Other | If this intervention is chosen randomly, the trainee will use water only technique for insertion. Receives: Procedure: Water-only infusion technique |
| Water and Air Insufflation | Other | If this intervention is chosen randomly, the trainee will use water and air insufflation technique for insertion. Receives: Procedure: Water infusion and air insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal Intubation Rate
The percentage of success in which the trainee advances the colonoscope to the cecum.
Measured: Cecal intubation rate with a 12-15 minute time limit before staff takes over
Secondary outcomes (7)
Time to transverse colon intubation
The time it takes for the trainee to insert the colonoscope to intubate the transverse colon.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Any complications that take place within the time frame of the procedure will be recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start22 Jun 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Water Assisted ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria MacDonald, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987645
- Sponsor's protocol ID
- 2021.161
- Status last verified
- Oct 2023
- First submitted
- 20 Jul 2021
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24890443Lee 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.
PubMed 25493011Leung 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.
PubMed 20593332Hu 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.
PubMed 23652813
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training
- ClinicalTrials.gov ID
- NCT04987645
- Acronym / sponsor ID
- 2021.161
- Conditions
- Water Assisted Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Water-Assisted Colonoscopy | Other | Procedure: Water-only infusion techniqueIf this intervention is chosen randomly, the trainee will use water only technique for insertion. |
| Water and Air Insufflation | Other | Procedure: Water infusion and air insufflationIf this intervention is chosen randomly, the trainee will use water and air insufflation technique for insertion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water-only infusion techniqueDuring 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. | Procedure or surgery | Water-Assisted Colonoscopy |
| Water infusion and air insufflationDuring 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. | Procedure or surgery | Water and Air Insufflation |
Primary outcome
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.
7 secondary outcomes
Time to transverse colon intubation
Time frame: Time from the start of the colonoscopy until the trainee reaches the transverse colon.
Patient comfort
Time frame: Recorded during the colonoscopy
Sedation dosage required
Time frame: Duration of the colonoscopy
Semi-structured exit interview
Time frame: After the data extraction (five minutes to complete)
Rate of transverse colon intubation
Time frame: 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.
Complications during the procedure
Time frame: Any complications that take place within the time frame of the procedure will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Background: PubMed 24890443Hsieh 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.
- Background: PubMed 25493011Lee 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.
- Background: PubMed 20593332Leung 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.
- Background: PubMed 23652813Hu 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.
- Individual participant dataSharing planned: No
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Not yet recruiting
The Effect of Cap-assisted Water Exchange Colonoscopy on Straight Passage of the Colonoscope Through the Sigmoid Colon, Without Loop Formation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-only infusion technique and Water infusion and air insufflation in people with Water Assisted Colonoscopy, run by Memorial University of Newfoundland at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cecal Intubation Rate (time frame: Cecal intubation rate with a 12-15 minute time limit before staff takes over). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04987645, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.