Colon NeoplasmNCT01699399
Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation
A study testing water immersion, water exchange and air insufflation in people with Colon Neoplasm, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
This prospective, randomized controlled trial compares traditional air insufflation with water immersion and water exchange in patients undergoing colonoscopy using on demand sedation. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colon Neoplasm
- What is being tested?
- water immersion, water exchange and air insufflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Dec 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing colonoscopy performed by the endoscopist at our endoscopic suite
Who cannot join
- request for sedation, indicated for bidirectional endoscopy, obstructive lesions of the colon, allergy to meperidine or propofol, American Society of Anesthesiology (ASA) risk Class 3 or higher, massive ascites, past history of partial colectomy, or refusal to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Trial Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation
This prospective, randomized controlled trial compares traditional air insufflation with water immersion and water exchange in patients undergoing colonoscopy using on demand sedation. We test the hypothesis that compared with air insufflation the proportion of patients who require on demand sedation during colonoscopy will be significantly lowered by water immersion and water exchange, and water exchange will produce the greatest reduction
Read the detailed description
The patients will be allocated into 3 groups by computerized randomization. In group A (water exchange), water will be infused and removed at the same time throughout the entire colon during the insertion phase with the air pump turned off. In group B (water immersion), water will be infused in the insertion phase and removed in the withdrawal phase. The water will be used mainly to open the lumen, without attempting to clear the colon contents. In group A and B, warm-to-touch water will be infused mainly infused through the accessory channel of the colonoscope using a foot-switch controlled water pump (JW2, Fujinon, Saitama, Japan). Air insufflation not used until the cecum has been reached. . In group C, air insufflation will be used throughout the procedure. Aliquots of 30 to 50 ml of water will be used for washing residual stool, as needed. In all three groups, loop reduction maneuvers, abdominal compression and change of patient position will be utilized at the discretion of the colonoscopist and recorded. Intubation of the cecum will be defined as successful only if the base of the cecum is touched with the tip of the colonoscope. Detailed examinations will be undertaken during the withdrawal phase.
During colonoscopy, a study nurse will ask the patient to report the level of pain (0 = none, 10 = most severe) at 2 to 3-minute intervals or at any time the patient voiced discomfort. For pain scores ≧2, maneuvers to minimize pain will be implemented. Immediately thereafter, the nurse will offer sedation, which the patients can accept or decline. If accepted, after an initial bolus of 1 mg/kg or 0.5 mg/kg for patients over 65 years propofol (Diprivan, Astra-Zeneca, Stockholm, Sweden) will be titrated in 20- to 30-mg increments to achieve an adequate level of sedation. The need of additional drug will be estimated by patient pain response (moans, grimaces and movements). Usually no more propofol will be added during the withdrawal phase. The initial amount of propofol, and those before and after arrival to the cecum will be recorded.
The following parameters will be evaluated and recorded on the patient data sheet: quality of bowel preparation, cecal intubation time, withdrawal time total procedure time, use of abdominal pressure, need for changing position, presence of polyps and reasons for incomplete colonoscopy.
The procedure will be recorded and stored as digital files.
- Conditions
- Colon Neoplasm
- Being tested
- water immersion, water exchange, air insufflation
- Keywords
- colonoscopy, pain, sedation, water
- Medical subject headings
- Colonic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water immersionProcedure or surgery
water exchangeProcedure or surgery
air insufflationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| water immersion | Experimental | infuse water during insertion phase of colonoscopy instead of air insufflation; remove the water during withdrawal phase. Receives: Procedure: water immersion |
| water exchange | Experimental | infuse and remove water during the insertion phase of colonoscopy. Air insufflation is used only in the withdrawal phase Receives: Procedure: water exchange |
| air insufflation | Active comparator | standard colonoscopy using traditional air insufflation during insertion Receives: Procedure: air insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of patients requiring sedation
Measured: 3 months
Secondary outcomes (1)
patient pain during insertion
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon NeoplasmStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Hsi hsieh, Dalin Tzu Chi General Hospital
- Investigators
- Yu-Hsi Hsieh, M.D., Principal investigator, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699399
- Sponsor's protocol ID
- DTCRD101(2)-E-03
- Status last verified
- May 2019
- First submitted
- 30 Sep 2012
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.
PubMed 21633535Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.
PubMed 20619405Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
PubMed 20883846
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation
- ClinicalTrials.gov ID
- NCT01699399
- Acronym / sponsor ID
- DTCRD101(2)-E-03
- Conditions
- Colon Neoplasm
- Keywords
- colonoscopy, pain, sedation, water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 3 Oct 2012 (estimated)
- 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 prospective, randomized controlled trial compares traditional air insufflation with water immersion and water exchange in patients undergoing colonoscopy using on demand sedation. We test the hypothesis that compared with air insufflation the proportion of patients who require on demand sedation during colonoscopy will be significantly lowered by water immersion and water exchange, and water exchange will produce the greatest reduction
Detailed description
The patients will be allocated into 3 groups by computerized randomization. In group A (water exchange), water will be infused and removed at the same time throughout the entire colon during the insertion phase with the air pump turned off. In group B (water immersion), water will be infused in the insertion phase and removed in the withdrawal phase. The water will be used mainly to open the lumen, without attempting to clear the colon contents. In group A and B, warm-to-touch water will be infused mainly infused through the accessory channel of the colonoscope using a foot-switch controlled water pump (JW2, Fujinon, Saitama, Japan). Air insufflation not used until the cecum has been reached. . In group C, air insufflation will be used throughout the procedure. Aliquots of 30 to 50 ml of water will be used for washing residual stool, as needed. In all three groups, loop reduction maneuvers, abdominal compression and change of patient position will be utilized at the discretion of the colonoscopist and recorded. Intubation of the cecum will be defined as successful only if the base of the cecum is touched with the tip of the colonoscope. Detailed examinations will be undertaken during the withdrawal phase.
During colonoscopy, a study nurse will ask the patient to report the level of pain (0 = none, 10 = most severe) at 2 to 3-minute intervals or at any time the patient voiced discomfort. For pain scores ≧2, maneuvers to minimize pain will be implemented. Immediately thereafter, the nurse will offer sedation, which the patients can accept or decline. If accepted, after an initial bolus of 1 mg/kg or 0.5 mg/kg for patients over 65 years propofol (Diprivan, Astra-Zeneca, Stockholm, Sweden) will be titrated in 20- to 30-mg increments to achieve an adequate level of sedation. The need of additional drug will be estimated by patient pain response (moans, grimaces and movements). Usually no more propofol will be added during the withdrawal phase. The initial amount of propofol, and those before and after arrival to the cecum will be recorded.
The following parameters will be evaluated and recorded on the patient data sheet: quality of bowel preparation, cecal intubation time, withdrawal time total procedure time, use of abdominal pressure, need for changing position, presence of polyps and reasons for incomplete colonoscopy.
The procedure will be recorded and stored as digital files.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| water immersion | Experimental | Procedure: water immersioninfuse water during insertion phase of colonoscopy instead of air insufflation; remove the water during withdrawal phase. |
| water exchange | Experimental | Procedure: water exchangeinfuse and remove water during the insertion phase of colonoscopy. Air insufflation is used only in the withdrawal phase |
| air insufflation | Active comparator | Procedure: air insufflationstandard colonoscopy using traditional air insufflation during insertion |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing colonoscopy performed by the endoscopist at our endoscopic suite
Key exclusion criteria (1 listed)
- request for sedation, indicated for bidirectional endoscopy, obstructive lesions of the colon, allergy to meperidine or propofol, American Society of Anesthesiology (ASA) risk Class 3 or higher, massive ascites, past history of partial colectomy, or refusal to provide written informed consent.
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 immersion | Procedure or surgery | water immersion |
| water exchange | Procedure or surgery | water exchange |
| air insufflation | Procedure or surgery | air insufflation |
Primary outcome
Proportions of patients requiring sedation
Time frame: 3 months
1 secondary outcome
patient pain during insertion
Time frame: 3 months
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 21 May 2019.
- Background: PubMed 21633535Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.
- Background: PubMed 20619405Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.
- Background: PubMed 20883846Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
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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.
Yu-Hsi Hsieh, M.D. principal investigator
Dalin Tzu Chi General Hospital
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 immersion, water exchange and air insufflation in people with Colon Neoplasm, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 21 May 2019. 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 Taiwan. 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?
Proportions of patients requiring sedation (time frame: 3 months). 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 NCT01699399, which also lists 3 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 21 May 2019.