Colonoscopy Diagnostic Techniques and ProceduresPhase 2NCT01341847
The Water Method Colonoscopy in Routine Unsedated Colonoscopy Examinations
A Phase 2 study testing water method colonoscopy and air method colonoscopy in people with Colonoscopy Diagnostic Techniques and Procedures, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
Aim of the Study : This study will compare the colonoscopy examination between the air method (air insufflation) and water method (water infusion) in unsedated patients with indication (symptoms and signs based) of colonoscopy examination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy Diagnostic Techniques and Procedures
- What is being tested?
- water method colonoscopy and air method colonoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIndonesia
- Study dates
- Apr 2011to Jun 2012
- 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 for 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 cause) so that impossible to pass the scope through the obstructed segment;
- Patients with communication problems.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Endoscopy Room of Dr Sardjito General Hospital
Yogyakarta, Special Province of Yogyakarta, 55284
About this study
Official title: The Water Method Colonoscopy in Routine Unsedated Colonoscopy Examinations : A Randomized Controlled Trial(RCT) in Diagnostic Cases in Indonesian Patients
Aim of the Study :
This study will compare the colonoscopy examination between the air method (air insufflation) and water method (water infusion) in unsedated patients with indication (symptoms and signs based) of colonoscopy examination. This study is based on earlier study which showed that water method had better results in reducing abdominal pain, caecal intubation and patients willingness to repeat colonoscopy examination than air method.
Read more
Background:
Colonoscopy examination is an important method to examine and establish the diagnosis of various diseases in the colon. Colonoscopy is successful when the tip of the scope reach the cecum and observe the caecal valve and/ or appendix orifice. This examination can be performed unsedated or under sedation (conscious sedation or deep sedation/general anaesthesia). The main disadvantage of unsedated colonoscopy method is the abdominal discomfort or pain during examination that may make patient distress and hemodynamically unstable and possibly stoppage of the examination before reach the cecum, but the severity of abdominal symptoms is vary from patient to patient. Many efforts have been tried to reduce the abdominal discomfort during examination. This unsedated method with air insufflation is our hospital standard method for colonoscopy examination since early 1980s, and less than 1% of patients were colonoscopied with conscious or deep sedation. Our study showed the success rate of this standard unsedated method was about 82%. The advantage of this method is inexpensive (feasible for most of people in developing country like us), patient may be examined ambulatory without escort, may back to work as soon as the examination is finished. Studies showed that replace the air insufflation with water infusion into colon since the beginning of the examination increased the success rate of caecal intubation and reduced the abdominal pain symptoms during colonoscopy examination(1). Sedation or general anaesthesia may increase the success rate of colonoscopy examination but it is costly, and may increase the adverse event especially in the elderly or patients with significance cardiopulmonary problems.
Research Design and Methods:
Eligible patients in the hospital clinics or wards will be offered to follow unsedated colonoscopy examination. The principle investigator (PI) will explain the study, the colonoscopy procedure , the various symptoms that may be felt during examination, the possible adverse event and medical effort to prevent it. Patient who sign the informed consent will be included in the study.
Methods on the day of exam. Enrolled patients will be sent to the endoscopy room and colonoscopy will be performed by the principle investigator. Patient lie on the left lateral position with right hip and knee flexed and left leg straight. When the PI about to start the single-handed colonoscopy examination, the blinded observer open the sealed envelops with the code enclosed. A standard colonoscope will be inserted. Patient may be ordered to change the position and or abdominal compression may be applied by nurse to aid the colonoscope advancement. Oximetry, cardiac rhythm and blood pressure will be monitored during examination. Blinding will not be performed in this study because of the feeling of water or air effect inside the colon can be differentiated by the patient so that in our opinion it actually can not be blinded..The control method includes usual air insufflation during insertion and shortening maneuvers. The study method includes only water infusion (air pump is turned off) through the colonoscope during insertion since the scope is inserted into the anus until reach the cecum. Water will be infused as needed under endoscopist judgement through the adaptor on biopsy channel with endoscopic washer pump. The usual air insufflation will be used during colonoscope withdrawal to facilitate mucosal examination and perform any other intervention, such as biopsy. Hypothesis testing: The unsedated colonoscopy with natural temperature water infusion minimize the pain symptoms than unsedated colonoscopy with usual air insufflation.
- Being tested
- water method colonoscopy, air method colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water method colonoscopyProcedure or surgery
This technique allow only water infusion (air pump is turned off) through the adaptor on the biopsy channel of colonoscope during insertion since the scope is inserted into the anus until reach the cecum.
air method colonoscopyProcedure or surgery
This technique only use usual air insufflation technique during colonoscope insertion and shortening maneuvers.
| Study group | Role | What they receive |
|---|---|---|
| Water method colonoscopy | Active comparator | This technique allow only water infusion (air pump is turned off) through the adaptor on the biopsy channel of the colonoscope during insertion since the scope is inserted into the anus until reach the cecum. Water will be infused as needed under endoscopist judgement through the adaptor on biopsy channel with endoscopic washer pump. The usual air insufflation will be used during colonoscope withdrawal to facilitate mucosal examination and perform any other intervention, such as biopsy Receives: Procedure: water method colonoscopy |
| air method colonoscopy | Other | This technique only use usual air insufflation technique during colonoscope insertion and shortening maneuvers. Receives: Procedure: air method colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal discomfort score
The level of abdominal discomfort experienced by the patient during the colonoscopy examination and reported to a blinded observer shortly before discharge (5 to 10 minutes after colonoscopy) will be measured on a linier visual analog scale :0=none, 10= most severe
Measured: one year
Secondary outcomes (1)
Cecal Intubation
Touching the tip of the colonoscope to the cecum with visualization of the ileocecal valve and/or appendix orifice
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy Diagnostic Techniques and ProceduresStudies 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
- None (open label)
- Enrolment
- 110 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, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Gadjah Mada University/Sardjito General Hospital, Yogyakarta, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341847
- Sponsor's protocol ID
- PB-63
- Status last verified
- Jul 2012
- First submitted
- 25 Apr 2011
- Last updated
- 4 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Water Method Colonoscopy in Routine Unsedated Colonoscopy Examinations : A Randomized Controlled Trial(RCT) in Diagnostic Cases in Indonesian Patients
- ClinicalTrials.gov ID
- NCT01341847
- Acronym / sponsor ID
- PB-63
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Apr 2011 (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.
Aim of the Study :
This study will compare the colonoscopy examination between the air method (air insufflation) and water method (water infusion) in unsedated patients with indication (symptoms and signs based) of colonoscopy examination. This study is based on earlier study which showed that water method had better results in reducing abdominal pain, caecal intubation and patients willingness to repeat colonoscopy examination than air method.
Background:
Colonoscopy examination is an important method to examine and establish the diagnosis of various diseases in the colon. Colonoscopy is successful when the tip of the scope reach the cecum and observe the caecal valve and/ or appendix orifice. This examination can be performed unsedated or under sedation (conscious sedation or deep sedation/general anaesthesia). The main disadvantage of unsedated colonoscopy method is the abdominal discomfort or pain during examination that may make patient distress and hemodynamically unstable and possibly stoppage of the examination before reach the cecum, but the severity of abdominal symptoms is vary from patient to patient. Many efforts have been tried to reduce the abdominal discomfort during examination. This unsedated method with air insufflation is our hospital standard method for colonoscopy examination since early 1980s, and less than 1% of patients were colonoscopied with conscious or deep sedation. Our study showed the success rate of this standard unsedated method was about 82%. The advantage of this method is inexpensive (feasible for most of people in developing country like us), patient may be examined ambulatory without escort, may back to work as soon as the examination is finished. Studies showed that replace the air insufflation with water infusion into colon since the beginning of the examination increased the success rate of caecal intubation and reduced the abdominal pain symptoms during colonoscopy examination(1). Sedation or general anaesthesia may increase the success rate of colonoscopy examination but it is costly, and may increase the adverse event especially in the elderly or patients with significance cardiopulmonary problems.
Research Design and Methods:
Eligible patients in the hospital clinics or wards will be offered to follow unsedated colonoscopy examination. The principle investigator (PI) will explain the study, the colonoscopy procedure , the various symptoms that may be felt during examination, the possible adverse event and medical effort to prevent it. Patient who sign the informed consent will be included in the study.
Methods on the day of exam. Enrolled patients will be sent to the endoscopy room and colonoscopy will be performed by the principle investigator. Patient lie on the left lateral position with right hip and knee flexed and left leg straight. When the PI about to start the single-handed colonoscopy examination, the blinded observer open the sealed envelops with the code enclosed. A standard colonoscope will be inserted. Patient may be ordered to change the position and or abdominal compression may be applied by nurse to aid the colonoscope advancement. Oximetry, cardiac rhythm and blood pressure will be monitored during examination. Blinding will not be performed in this study because of the feeling of water or air effect inside the colon can be differentiated by the patient so that in our opinion it actually can not be blinded..The control method includes usual air insufflation during insertion and shortening maneuvers. The study method includes only water infusion (air pump is turned off) through the colonoscope during insertion since the scope is inserted into the anus until reach the cecum. Water will be infused as needed under endoscopist judgement through the adaptor on biopsy channel with endoscopic washer pump. The usual air insufflation will be used during colonoscope withdrawal to facilitate mucosal examination and perform any other intervention, such as biopsy. Hypothesis testing: The unsedated colonoscopy with natural temperature water infusion minimize the pain symptoms than unsedated colonoscopy with usual air insufflation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water method colonoscopy | Active comparator | Procedure: water method colonoscopyThis technique allow only water infusion (air pump is turned off) through the adaptor on the biopsy channel of the colonoscope during insertion since the scope is inserted into the anus until reach the cecum. Water will be infused as needed under endoscopist judgement through the adaptor on biopsy channel with endoscopic washer pump. The usual air insufflation will be used during colonoscope withdrawal to facilitate mucosal examination and perform any other intervention, such as biopsy |
| air method colonoscopy | Other | Procedure: air method colonoscopyThis technique only use usual air insufflation technique during colonoscope insertion and shortening maneuvers. |
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 for colonoscopy examination
Key exclusion criteria (5 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 cause) so that impossible to pass the scope through the obstructed segment;
- Patients with communication problems.
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 method colonoscopyThis technique allow only water infusion (air pump is turned off) through the adaptor on the biopsy channel of colonoscope during insertion since the scope is inserted into the anus until reach the cecum. | Procedure or surgery | Water method colonoscopy |
| air method colonoscopyThis technique only use usual air insufflation technique during colonoscope insertion and shortening maneuvers. | Procedure or surgery | air method colonoscopy |
Primary outcome
Abdominal discomfort score
Time frame: one year
The level of abdominal discomfort experienced by the patient during the colonoscopy examination and reported to a blinded observer shortly before discharge (5 to 10 minutes after colonoscopy) will be measured on a linier visual analog scale :0=none, 10= most severe
1 secondary outcome
Cecal Intubation
Time frame: one year
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 4 Jul 2012.
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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.
Putut Bayupurnama, MD principal investigator
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Gadjah Mada University/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 water method colonoscopy and air method colonoscopy in people with Colonoscopy Diagnostic Techniques and Procedures, 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 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: finished, as of the sponsor's last update on 4 Jul 2012. 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?
Abdominal discomfort score (time frame: one year). 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 4 Jul 2012.