Colon NeoplasmNCT01535326
Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy
A study testing air insufflation, water immersion and water exchange in people with Colon Neoplasm and Pain, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colon Neoplasm, Pain
- What is being tested?
- air insufflation, water immersion and water exchange
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 minimally sedated colonoscopy
Who cannot join
- Obstructive lesions of the colon, inadequate bowel preparation, allergy to meperidine, 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: Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial
In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange).
This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.
Read the detailed description
All procedures will be recorded and stored as digital files.
- Conditions
- Colon Neoplasm, Pain
- Being tested
- air insufflation, water immersion, water exchange
- Keywords
- colonoscopy
- 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.
air insufflationProcedure or surgery
insufflate air during the insertion of colonoscopy
water immersionProcedure or surgery
infuse water during insertion, aspirate water during withdrawal
water exchangeProcedure or surgery
infuse and remove water during insertion phase of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| air insufflation | Placebo comparator | Use air insufflation during colonoscopy Receives: Procedure: air insufflation |
| water immersion | Active comparator | infuse water during insertion, remove water during withdrawal of colonoscopy Receives: Procedure: water immersion |
| water exchange | Active comparator | infuse and remove water during insertion phase of colonoscopy Receives: Procedure: water exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Without Pain
proportion of patients without insertion pain during colonoscopy
Measured: up to 12 months
Secondary outcomes (3)
Patient Pain Score
The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)
Measured: 9 to 12 months
Patient Satisfaction Score
satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied
Measured: 9 to 12 months
Number of Participants With at Least One Adenoma
the number of participants with at least one adenoma in each of the study groups.
Measured: 9 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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
- 270 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, Dr., Principal investigator, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535326
- Sponsor's protocol ID
- DalinTCGH-hsieh-01
- Status last verified
- Jul 2014
- First submitted
- 11 Feb 2012
- Last updated
- 15 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- 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 F, Harker J, Leung J, Siao-Salera R, Mann S, Ramirez F, Friedland S, Amato A, Radaelli F, Paggi S, Terruzzi V, Hsieh Y. Removal of infused water predominantly during insertion (water exchange) is consistently associated with a greater reduction of pain score - review of randomized controlled trials (RCTs) of water method colonoscopy. J Interv Gastroenterol. 2011 Jul;1(3):114-120. doi: 10.4161/jig.1.3.18510. Epub 2011 Jul 1.
PubMed 22163081Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.
PubMed 21184876Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.
PubMed 19555938
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01535326
- Acronym / sponsor ID
- DalinTCGH-hsieh-01
- Conditions
- Colon Neoplasm, Pain
- Keywords
- colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange).
This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.
Detailed description
All procedures 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 |
|---|---|---|
| air insufflation | Placebo comparator | Procedure: air insufflationUse air insufflation during colonoscopy |
| water immersion | Active comparator | Procedure: water immersioninfuse water during insertion, remove water during withdrawal of colonoscopy |
| water exchange | Active comparator | Procedure: water exchangeinfuse and remove water during insertion phase of colonoscopy |
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 minimally sedated colonoscopy
Key exclusion criteria (1 listed)
- Obstructive lesions of the colon, inadequate bowel preparation, allergy to meperidine, 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 |
|---|---|---|
| air insufflationinsufflate air during the insertion of colonoscopy | Procedure or surgery | air insufflation |
| water immersioninfuse water during insertion, aspirate water during withdrawal | Procedure or surgery | water immersion |
| water exchangeinfuse and remove water during insertion phase of colonoscopy | Procedure or surgery | water exchange |
Primary outcome
Proportion of Patients Without Pain
Time frame: up to 12 months
proportion of patients without insertion pain during colonoscopy
3 secondary outcomes
Patient Pain Score
Time frame: 9 to 12 months
Patient Satisfaction Score
Time frame: 9 to 12 months
Number of Participants With at Least One Adenoma
Time frame: 9 to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 22163081Leung F, Harker J, Leung J, Siao-Salera R, Mann S, Ramirez F, Friedland S, Amato A, Radaelli F, Paggi S, Terruzzi V, Hsieh Y. Removal of infused water predominantly during insertion (water exchange) is consistently associated with a greater reduction of pain score - review of randomized controlled trials (RCTs) of water method colonoscopy. J Interv Gastroenterol. 2011 Jul;1(3):114-120. doi: 10.4161/jig.1.3.18510. Epub 2011 Jul 1.
- Background: PubMed 21184876Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.
- Background: PubMed 19555938Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.
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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, Dr. 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 air insufflation, water immersion and water exchange in people with Colon Neoplasm and Pain, 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 15 Aug 2014. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients Without Pain (time frame: up to 12 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 NCT01535326, 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 15 Aug 2014.