Effect of Endoscope Water Pump Flow RatesPhase 2NCT01869296
The Effect of Endoscope Water Pump Flow Rates on Successful Unsedated Colonoscopy by Water Immersion Method: a Randomized Controlled Trial
A Phase 2 study testing higher flow rates and lower flow rates in people with Effect of Endoscope Water Pump Flow Rates, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
The purpose of this study is to compare the cecal intubation rate between two endoscopy water pump with different flow rates (1.7 ml/sec vs 10.4 ml/sec) in water immersion colonoscopy examination in unsedated patients undergoing diagnostic colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effect of Endoscope Water Pump Flow Rates
- What is being tested?
- higher flow rates and lower flow rates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteIndonesia
- Study dates
- May 2013to Jun 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult > 18 years old with indication for colonoscopy, such as chronic diarrhea, chronic constipation, hematochezia, chronic lower abdominal pain, positive fecal occult blood test, and other change of bowel habit symptoms indicative of need for diagnostic colonoscopy examination
Who cannot join
- Patients refuse to participate, patient with obstructive lesion in the colon distal of the cecum, patients with experienced of colon resection, hemodynamically unstable, severe cardiac disorders (such as acute myocardial infarction, unstable angina, malignant arrhythmia, and moderate to severe congestive heart failure), patients with fecal obstruction (whatever the causes) so that impossible to pass the scope through the obstructed segment.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Sardjito General Hospital
Yogyakarta, Special Region of Yogyakarta, 55284
About this study
Official title: The Effect of Endoscopy Water Pump Flow Rates on Successful Unsedated Colonoscopy by Water Immersion Method: a Randomized Controlled Trial
The purpose of this study is to compare the cecal intubation rate between two endoscopy water pump with different flow rates (1.7 ml/sec vs 10.4 ml/sec) in water immersion colonoscopy examination in unsedated patients undergoing diagnostic colonoscopy.
- Being tested
- higher flow rates, lower flow rates
- Keywords
- unsedated, water immersion colonoscopy, endoscope water pump flow rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
higher flow ratesProcedure or surgery
higher flow rates endoscope pump water immersion colonoscopy : 10.4 ml/sec
lower flow ratesProcedure or surgery
lower flow rates endoscope pump water immersion colonoscopy : 1.7 ml/sec
| Study group | Role | What they receive |
|---|---|---|
| higher flow rates endoscope pump | Active comparator | higher flow rates endoscope water pump : 10.4 ml/sec Receives: Procedure: higher flow rates |
| lower flow rates endoscope water pump | Experimental | lower flow rates endoscope water pump : 1.7 ml/sec Receives: Procedure: lower flow rates |
What is being measured
The primary outcome is the main question the study is designed to answer.
cecal intubation rate
Measured: 1.5 years
Secondary outcomes (7)
Cecal intubation time
Measured: 1.5 years
Abdominal discomfort score
Measured: 1.5 years
Willingness to repeat
Measured: 1.5 years
Causes of unsuccessful
Measured: 1.5 years
Abdominal compression
Measured: 1.5 years
Position change
Measured: 1.5 years
Diagnostic lesions
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of Endoscope Water Pump Flow RatesStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PUTUT BAYUPURNAMA, Gadjah Mada University
- Investigators
- Putut Bayupurnama, MD, Principal investigator, Div of Gastroenterology and Hepatology, Dept of Internal Medicine,Fac of Medicine, Gadjah Mada University/Dr.Sardjito General Hospital,Yogyakarta,Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869296
- Sponsor's protocol ID
- PB-02-CWUGM
- Status last verified
- Aug 2016
- First submitted
- 26 May 2013
- Last updated
- 11 Aug 2016
- Results posted
- No
Publications
Bayupurnama P, Ratnasari N, Indrarti F, Triwikatmani C, Maduseno S, Nurdjanah S, Leung FW. Endoscope-connected water pump with high flow rates improves the unsedated colonoscopy performance by water immersion method. Clin Exp Gastroenterol. 2018 Jan 12;11:13-18. doi: 10.2147/CEG.S152669. eCollection 2018.
PubMed 29391819
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endoscopy Water Pump Flow Rates on Successful Unsedated Colonoscopy by Water Immersion Method: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01869296
- Acronym / sponsor ID
- PB-02-CWUGM
- Keywords
- unsedated, water immersion colonoscopy, endoscope water pump flow rates
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Jun 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.
The purpose of this study is to compare the cecal intubation rate between two endoscopy water pump with different flow rates (1.7 ml/sec vs 10.4 ml/sec) in water immersion colonoscopy examination in unsedated patients undergoing diagnostic colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| higher flow rates endoscope pump | Active comparator | Procedure: higher flow rateshigher flow rates endoscope water pump : 10.4 ml/sec |
| lower flow rates endoscope water pump | Experimental | Procedure: lower flow rateslower flow rates endoscope water pump : 1.7 ml/sec |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult > 18 years old with indication for colonoscopy, such as chronic diarrhea, chronic constipation, hematochezia, chronic lower abdominal pain, positive fecal occult blood test, and other change of bowel habit symptoms indicative of need for diagnostic colonoscopy examination
Key exclusion criteria (1 listed)
- Patients refuse to participate, patient with obstructive lesion in the colon distal of the cecum, patients with experienced of colon resection, hemodynamically unstable, severe cardiac disorders (such as acute myocardial infarction, unstable angina, malignant arrhythmia, and moderate to severe congestive heart failure), patients with fecal obstruction (whatever the causes) so that impossible to pass the scope through the obstructed segment.
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 |
|---|---|---|
| higher flow rateshigher flow rates endoscope pump water immersion colonoscopy : 10.4 ml/sec | Procedure or surgery | higher flow rates endoscope pump |
| lower flow rateslower flow rates endoscope pump water immersion colonoscopy : 1.7 ml/sec | Procedure or surgery | lower flow rates endoscope water pump |
Primary outcome
cecal intubation rate
Time frame: 1.5 years
7 secondary outcomes
Cecal intubation time
Time frame: 1.5 years
Abdominal discomfort score
Time frame: 1.5 years
Willingness to repeat
Time frame: 1.5 years
Causes of unsuccessful
Time frame: 1.5 years
Abdominal compression
Time frame: 1.5 years
Position change
Time frame: 1.5 years
Diagnostic lesions
Time frame: 1.5 years
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 11 Aug 2016.
- Derived from this study: PubMed 29391819Bayupurnama P, Ratnasari N, Indrarti F, Triwikatmani C, Maduseno S, Nurdjanah S, Leung FW. Endoscope-connected water pump with high flow rates improves the unsedated colonoscopy performance by water immersion method. Clin Exp Gastroenterol. 2018 Jan 12;11:13-18. doi: 10.2147/CEG.S152669. eCollection 2018.
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.
Putut Bayupurnama, MD principal investigator
Div of Gastroenterology and Hepatology, Dept of Internal Medicine,Fac of Medicine, Gadjah Mada University/Dr.Sardjito General Hospital,Yogyakarta,Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing higher flow rates and lower flow rates in people with Effect of Endoscope Water Pump Flow Rates, run by Gadjah Mada University at 1 site in Indonesia.
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 11 Aug 2016. 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 Indonesia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
cecal intubation rate (time frame: 1.5 years). 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 NCT01869296, which also lists 1 linked publication.
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 11 Aug 2016; AzTrials last refreshed its copy on 7 Nov 2026.