Minimally Sedated Patient Undergoing ColonoscopyNCT01948284
Comparing Maximal and Half-maximal Suction Pressure Applied During Water Exchange in Colonoscopy
A study testing half-maximal pressure, maximal pressure and Suction Unit in people with Minimally Sedated Patient Undergoing Colonoscopy, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
This prospective, randomize, controlled trial will compared maximal to half-maximal suction pressure applied during water exchange in patients undergoing minimally sedated colonoscopy. We test the hypothesis that maximal suction pressure is more efficient and causes shorter insertion time. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Minimally Sedated Patient Undergoing Colonoscopy
- What is being tested?
- half-maximal pressure, maximal pressure and Suction Unit
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to Feb 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing minimally sedated colonoscopy performed by YHH
Who cannot join
- known history of obstructive lesions of the colon,
- 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.
Taiwan1 site, 1 recruiting
- Recruiting
Buddhist Dalin Tzu Chi General Hospital
Chiayi City, Taiwan, 622
Yu-Hsi Hsieh, MD, hsieh.yuhsi@msa.hinet.net
Yu-Hsi Hsieh, MD
About this study
Official title: A Randomized, Controlled Trial Comparing Maximal and Half-maximal Suction Pressure Applied During Water Exchange in Colonoscopy
This prospective, randomize, controlled trial will compared maximal to half-maximal suction pressure applied during water exchange in patients undergoing minimally sedated colonoscopy. We test the hypothesis that maximal suction pressure is more efficient and causes shorter insertion time.
- Being tested
- half-maximal pressure, maximal pressure, Suction Unit
- Keywords
- cecal intubation time, water exchange, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
half-maximal pressureProcedure or surgery
the pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the half-maximal (-35 cm Hg).
maximal pressureProcedure or surgery
The pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the maximal (-70 cm Hg).
Suction UnitDevice
Also called suction unit (DF 601, Hanlien, Taipei, Taiwan)
| Study group | Role | What they receive |
|---|---|---|
| maximal suction pressure | Active comparator | The pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the maximal (-70 cm Hg). Receives: Procedure: maximal pressure; Device: Suction Unit |
| half-maximal pressure | Active comparator | The pressure level of the suction unit will be set at the half-maximal (-35 cm Hg). Receives: Procedure: half-maximal pressure; Device: Suction Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
cecal intubation time
Measured: 30 minutes
Secondary outcomes (4)
infused water amount
Measured: 30 minutes
aspirated water amount
Measured: 30 minutes
pain score
Measured: 30 minutes
suction marks on the mucosa
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (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 Minimally Sedated Patient Undergoing 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Felix Leung, MD, Sepulveda Ambulatory Care Center, VAGLAHS
- Responsible party
- Principal investigator, Yu-Hsi hsieh, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948284
- Sponsor's protocol ID
- DalinTzuChi-Hsieh-2013-2
- Status last verified
- Sep 2013
- First submitted
- 17 Sep 2013
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
PubMed 22898423Leung 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 19555938Wasan SK, Schroy PC 3rd. Water-assisted unsedated colonoscopy: does the end justify the means? Gastrointest Endosc. 2009 Mar;69(3 Pt 1):551-3. doi: 10.1016/j.gie.2008.10.045. No abstract available.
PubMed 19231498
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Comparing Maximal and Half-maximal Suction Pressure Applied During Water Exchange in Colonoscopy
- ClinicalTrials.gov ID
- NCT01948284
- Acronym / sponsor ID
- DalinTzuChi-Hsieh-2013-2
- Keywords
- cecal intubation time, water exchange, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Collaborators
- Felix Leung, MD, Sepulveda Ambulatory Care Center, VAGLAHS
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 23 Sep 2013 (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, randomize, controlled trial will compared maximal to half-maximal suction pressure applied during water exchange in patients undergoing minimally sedated colonoscopy. We test the hypothesis that maximal suction pressure is more efficient and causes shorter insertion time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maximal suction pressure | Active comparator | Procedure: maximal pressure, Device: Suction UnitThe pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the maximal (-70 cm Hg). |
| half-maximal pressure | Active comparator | Procedure: half-maximal pressure, Device: Suction UnitThe pressure level of the suction unit will be set at the half-maximal (-35 cm Hg). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing minimally sedated colonoscopy performed by YHH
Key exclusion criteria (5 listed)
- known history of obstructive lesions of the colon,
- 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 |
|---|---|---|
| half-maximal pressurethe pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the half-maximal (-35 cm Hg). | Procedure or surgery | half-maximal pressure |
| maximal pressureThe pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the maximal (-70 cm Hg). | Procedure or surgery | maximal suction pressure |
| Suction UnitAlso: suction unit (DF 601, Hanlien, Taipei, Taiwan) | Device | half-maximal pressure, maximal suction pressure |
Primary outcome
cecal intubation time
Time frame: 30 minutes
4 secondary outcomes
infused water amount
Time frame: 30 minutes
aspirated water amount
Time frame: 30 minutes
pain score
Time frame: 30 minutes
suction marks on the mucosa
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
- Background: PubMed 22898423Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
- 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.
- Background: PubMed 19231498Wasan SK, Schroy PC 3rd. Water-assisted unsedated colonoscopy: does the end justify the means? Gastrointest Endosc. 2009 Mar;69(3 Pt 1):551-3. doi: 10.1016/j.gie.2008.10.045. No abstract available.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing half-maximal pressure, maximal pressure and Suction Unit in people with Minimally Sedated Patient Undergoing Colonoscopy, 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 5 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 23 Sep 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Hsi Hsieh, MD (886-5-2648000 ext. 5204, hsieh.yuhsi@msa.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cecal intubation time (time frame: 30 minutes). 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 NCT01948284, 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 23 Sep 2013.