Colorectal CancerNCT03209349
Investigation of Cecal Intubation Rates and Pain Levels Between Water Exchange and Air Insufflation Flexible Sigmoidoscopy
A study testing Water Exchange Sigmoidoscopy and Air Insufflation Sigmoidoscopy in people with Colorectal Cancer, run by Kelowna Gastroenterology Associates at 2 sites in 2 countries.
Trial summary
This study evaluates how often patients without sedation that receive screening sigmoidoscopy are able to have their full colon examined without significant discomfort by comparing a new colonoscopy technique known as the water exchange technique to the traditional air insufflation technique. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Water Exchange Sigmoidoscopy and Air Insufflation Sigmoidoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Jun 2017to 3 Nov 2022
- 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 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic average risk (as per BC colon screening guidelines) individuals
- Ages 50-74 years of age
Who cannot join
- A sigmoidoscopy or colonoscopy within 10 years,
- A FIT within 2 years,
- Individuals classified with any high-risk screening criteria in accordance to the
- BC colon screening guidelines including:
- a personal history of adenoma,
- a first degree relative that was diagnosed with colorectal cancer or multiple adenomas under the age of 60,
- two or more first degree relatives with colorectal cancer at any age, longstanding inflammatory bowel diseases,
- a family history of familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer, - Individuals presenting with rectal pain, rectal bleeding, abdominal pain, or unintentional weight loss at the time of the examination.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Sepulveda Ambulatory Care Center
North Hills, California, 91343
About this study
Official title: Investigation of Cecal Intubation Rates and Pain Levels Between Water Exchange and Air Insufflation Flexible Sigmoidoscopy: A Randomized Controlled Study
This study evaluates how often patients without sedation that receive screening sigmoidoscopy are able to have their full colon examined without significant discomfort by comparing a new colonoscopy technique known as the water exchange technique to the traditional air insufflation technique. It compares the differences between complete colon exam rates for water exchange when compared to the traditional air technique. Patients will be randomised and blinded to the procedure type.
Previous studies have shown that the water exchange method is associated with a significant reduction in discomfort and often allows patients to receive colonoscopy without sedation or with only minimal sedation. However, the potential for water exchange to be used in the screening setting has yet to be evaluated. As per standard practices in sigmoidoscopy screening, patients will not be sedated. However, unlike standard practices in sigmoidoscopy screening, while maintaining minimal levels of discomfort, the investigators will attempt to scope beyond the distal colon.
Read the detailed description
Purpose:
This study is being conducted to evaluate whether a new technique, known as the water exchange technique can more frequently allow for the full colon to be examined in patients undergoing screening sigmoidoscopy.*
Hypothesis \& Goals \& Objectives:
It is hypothesised that there will be a 20% or greater difference in cecal intubation rate (ability for the colonoscope to reach the Ileocecal juncture, and thereby provide full examination of the colon) at a minimal and acceptable level of discomfort in non-sedated colon screening patients receiving a scope using the water-exchange method, when compared to the air insufflation method.
Justification:
Previous studies have shown that the water exchange method is associated with a significant reduction in discomfort and often allows patients to receive colonoscopy without sedation or with only minimal sedation. The ability to increase the likelihood of full colon examination at minimal discomfort has the opportunity to improve upon screening practices and increase the likelihood of patient participation as discomfort and fear of discomfort is a major factor that limits uptake of sigmoidoscopy and colonoscopy screening.
Research Design:
This study takes a patient and interviewer blinded and randomised study design. Patients will be randomly assigned to receive either the water exchange method or the air insufflation method. Rates of cecal intubation are compared across study arms.
Statistical Analysis Plan:
Effect differences in cecal intubation rates, and responses to whether the scope that they received was more uncomfortable than they expected, and whether they would be willing to receive the test again at their next screening interval will be compared using the Chi-Squared or, when the data necessitates, Fisher's Exact Test. Assuming a non-normal distribution in reported pain scores, the Mann Whitney U test will be used to assess the differences in maximum reported pain according to the Wong Baker Faces Pain Rating Scale between study arms.
*The term sigmoidoscopy is used here as patients are prepared for the procedure using a standard sigmoidoscopy protocol, rather than colonoscopy. That is, sedation is not administered; this is a standard practice for sigmoidoscopy procedures but not for colonoscopy.
- Conditions
- Colorectal Cancer
- Being tested
- Water Exchange Sigmoidoscopy, Air Insufflation Sigmoidoscopy
- Keywords
- Sigmoidoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water Exchange SigmoidoscopyProcedure or surgery
See arm description.
Air Insufflation SigmoidoscopyProcedure or surgery
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| Water Exchange Sigmoidoscopy | Experimental | As per standard practices, the patient will be walked to the procedure room and positioned in the left lateral position on the procedure bed, without pre-operative anesthesia. The procedures will be completed within the ambulatory endoscopy clinic at Kelowna General Hospital. The study will use the same colonoscopes that are already being used at KGH for colonoscopy. These are the Olympus 190 series colonoscopes. They can and will be fitted to support both water and air exchange.
For patients assigned the water exchange intervention arm, the insertion of the scope will be followed by infusion and suction of water to minimally distend the lumen. If the lumen does not open, the instrument will be retracted slightly and the infusion started again. As the scope is inserted and progressed through the intestinal lumen some of the infused water will be suctioned back constantly, exchanging clean for opaque water. Receives: Procedure: Water Exchange Sigmoidoscopy |
| Air Insufflation Sigmoidoscopy | Active comparator | As per standard practices, the patient will be walked to the procedure room and positioned in the left lateral position on the procedure bed, without pre-operative anesthesia. The procedures will be completed within the ambulatory endoscopy clinic at Kelowna General Hospital. The study will use the same colonoscopes that are already being used at KGH for colonoscopy. These are the Olympus 190 series colonoscopes. They can and will be fitted to support both water and air exchange.
For patients assigned to the air insufflation intervention arm, extended sigmoidoscopy will be performed with the minimum insufflation required to reach the cecum. Receives: Procedure: Air Insufflation Sigmoidoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full colon exam
Ability for patient to receive full exam of the colon with minimal discomfort
Measured: Immediately following the procedure
Secondary outcomes (2)
Recalled Discomfort
Patient will be contacted at 24 hours following the procedure and in order to document whether the scope was more uncomfortable than expected and if the patient would be willing to receive the test again at their next screening interval.
Measured: Immediately following the procedure
Adenoma detection rates
Histopathological testing and reporting will follow standard practices and adenoma detection rates will be documented and compared between study arms.
Measured: Immediately following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start14 Jun 2017
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kelowna Gastroenterology Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Veteran Affairs Sepulveda Ambulatory Care Cente
- Responsible party
- Sponsor
- Investigators
- Rafael Perini, MD, Principal investigator, Kelowna General Hospital, Department of GastroenterologyAdrian Bak, MD, Principal investigator, Kelowna General Hospital, Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209349
- Sponsor's protocol ID
- 2016-17-078-I
- Status last verified
- Nov 2022
- First submitted
- 14 Jun 2017
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Cecal Intubation Rates and Pain Levels Between Water Exchange and Air Insufflation Flexible Sigmoidoscopy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03209349
- Acronym / sponsor ID
- 2016-17-078-I
- Conditions
- Colorectal Cancer
- Keywords
- Sigmoidoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kelowna Gastroenterology AssociatesUniversity, hospital or other
- Collaborators
- Veteran Affairs Sepulveda Ambulatory Care Cente
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 6 Jul 2017 (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 evaluates how often patients without sedation that receive screening sigmoidoscopy are able to have their full colon examined without significant discomfort by comparing a new colonoscopy technique known as the water exchange technique to the traditional air insufflation technique. It compares the differences between complete colon exam rates for water exchange when compared to the traditional air technique. Patients will be randomised and blinded to the procedure type.
Previous studies have shown that the water exchange method is associated with a significant reduction in discomfort and often allows patients to receive colonoscopy without sedation or with only minimal sedation. However, the potential for water exchange to be used in the screening setting has yet to be evaluated. As per standard practices in sigmoidoscopy screening, patients will not be sedated. However, unlike standard practices in sigmoidoscopy screening, while maintaining minimal levels of discomfort, the investigators will attempt to scope beyond the distal colon.
Detailed description
Purpose:
This study is being conducted to evaluate whether a new technique, known as the water exchange technique can more frequently allow for the full colon to be examined in patients undergoing screening sigmoidoscopy.*
Hypothesis \& Goals \& Objectives:
It is hypothesised that there will be a 20% or greater difference in cecal intubation rate (ability for the colonoscope to reach the Ileocecal juncture, and thereby provide full examination of the colon) at a minimal and acceptable level of discomfort in non-sedated colon screening patients receiving a scope using the water-exchange method, when compared to the air insufflation method.
Justification:
Previous studies have shown that the water exchange method is associated with a significant reduction in discomfort and often allows patients to receive colonoscopy without sedation or with only minimal sedation. The ability to increase the likelihood of full colon examination at minimal discomfort has the opportunity to improve upon screening practices and increase the likelihood of patient participation as discomfort and fear of discomfort is a major factor that limits uptake of sigmoidoscopy and colonoscopy screening.
Research Design:
This study takes a patient and interviewer blinded and randomised study design. Patients will be randomly assigned to receive either the water exchange method or the air insufflation method. Rates of cecal intubation are compared across study arms.
Statistical Analysis Plan:
Effect differences in cecal intubation rates, and responses to whether the scope that they received was more uncomfortable than they expected, and whether they would be willing to receive the test again at their next screening interval will be compared using the Chi-Squared or, when the data necessitates, Fisher's Exact Test. Assuming a non-normal distribution in reported pain scores, the Mann Whitney U test will be used to assess the differences in maximum reported pain according to the Wong Baker Faces Pain Rating Scale between study arms.
*The term sigmoidoscopy is used here as patients are prepared for the procedure using a standard sigmoidoscopy protocol, rather than colonoscopy. That is, sedation is not administered; this is a standard practice for sigmoidoscopy procedures but not for colonoscopy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water Exchange Sigmoidoscopy | Experimental | Procedure: Water Exchange SigmoidoscopyAs per standard practices, the patient will be walked to the procedure room and positioned in the left lateral position on the procedure bed, without pre-operative anesthesia. The procedures will be completed within the ambulatory endoscopy clinic at Kelowna General Hospital. The study will use the same colonoscopes that are already being used at KGH for colonoscopy. These are the Olympus 190 series colonoscopes. They can and will be fitted to support both water and air exchange. For patients assigned the water exchange intervention arm, the insertion of the scope will be followed by infusion and suction of water to minimally distend the lumen. If the lumen does not open, the instrument will be retracted slightly and the infusion started again. As the scope is inserted and progressed through the intestinal lumen some of the infused water will be suctioned back constantly, exchanging clean for opaque water. |
| Air Insufflation Sigmoidoscopy | Active comparator | Procedure: Air Insufflation SigmoidoscopyAs per standard practices, the patient will be walked to the procedure room and positioned in the left lateral position on the procedure bed, without pre-operative anesthesia. The procedures will be completed within the ambulatory endoscopy clinic at Kelowna General Hospital. The study will use the same colonoscopes that are already being used at KGH for colonoscopy. These are the Olympus 190 series colonoscopes. They can and will be fitted to support both water and air exchange. For patients assigned to the air insufflation intervention arm, extended sigmoidoscopy will be performed with the minimum insufflation required to reach the cecum. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Asymptomatic average risk (as per BC colon screening guidelines) individuals
- Ages 50-74 years of age
Key exclusion criteria (8 listed)
- A sigmoidoscopy or colonoscopy within 10 years,
- A FIT within 2 years,
- Individuals classified with any high-risk screening criteria in accordance to the
- a personal history of adenoma,
- a first degree relative that was diagnosed with colorectal cancer or multiple adenomas under the age of 60,
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 Exchange SigmoidoscopySee arm description. | Procedure or surgery | Water Exchange Sigmoidoscopy |
| Air Insufflation SigmoidoscopySee arm description. | Procedure or surgery | Air Insufflation Sigmoidoscopy |
Primary outcome
Full colon exam
Time frame: Immediately following the procedure
Ability for patient to receive full exam of the colon with minimal discomfort
2 secondary outcomes
Recalled Discomfort
Time frame: Immediately following the procedure
Adenoma detection rates
Time frame: Immediately following the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Rafael Perini, MD principal investigator
Kelowna General Hospital, Department of Gastroenterology
Adrian Bak, MD principal investigator
Kelowna General Hospital, Department of Gastroenterology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Exchange Sigmoidoscopy and Air Insufflation Sigmoidoscopy in people with Colorectal Cancer, run by Kelowna Gastroenterology Associates at 2 sites in 2 countries.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Full colon exam (time frame: Immediately following the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2022.