Water Immersion Method Colonoscopy in Unsedated PatientsRLPvsLLPNCT03489824
Effectiveness of RL- vs LL-starting Position in Unsedated Water Immersion Colonoscopy
A study testing modified- WIM colonoscopy in people with Water Immersion Method Colonoscopy in Unsedated Patients, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
Abdominal discomfort is of the most important patient interest when in an unsedated colonoscopy examination. Water method for colonoscopy examination has been studied widely and evidence showed effectiveness in reducing discomfort and increase cecal intubation time and increasing cecal intubation rates in unsedated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Water Immersion Method Colonoscopy in Unsedated Patients
- What is being tested?
- modified- WIM colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteIndonesia
- Study dates
- 20 Feb 2018to 30 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ≥18 years old with the 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 the need for diagnostic colonoscopy examination.
Who cannot join
- Patients who refuse to participate, patients with obstructive lesions in the colon distal of the cecum. , patients with experienced colon resection, patients who are hemodynamically unstable, and patients with severe cardiac disorders (such as acute myocardial infarction, unstable angina, malignant arrhythmia, and moderate to severe congestive heart failure ).
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Endoscopy Room of Dr Sardjito General Hospital
Yogyakarta, Special Province of Yogyakarta, 55284
Abror
Putut Bayupurnama, MD
About this study
Official title: The Effectiveness of Right- vs Left-lateral Starting Position in Unsedated Colonoscopy With Modified-Water Immersion Method Colonoscopy
Abdominal discomfort is of the most important patient interest when in an unsedated colonoscopy examination. Water method for colonoscopy examination has been studied widely and evidence showed effectiveness in reducing discomfort and increase cecal intubation time and increasing cecal intubation rates in unsedated patients.
Read the detailed description
Abdominal discomfort is of the most important patient interest when in an unsedated colonoscopy examination. Water method for colonoscopy examination has been studied widely and evidence showed effectiveness in reducing discomfort and increase cecal intubation time and increasing cecal intubation rates in unsedated patients. Our previous studies showed that water immersion method reduced the VAS score, accelerated the intubation time significantly without different changing cecal intubation rate. Previous right-sided vs. left-sided starting position colonoscopy study in sedated patients with air insufflation colonoscopy method showed that right-sided starting position improved the abdominal discomfort score and faster cecal intubation time. We want postulate that the right-sided starting position can also maximize the water method advantages in lowering the discomfort score, faster cecal intubation time and higher cecal intubation rates, and it will improve patient acceptance of water unsedated colonoscopy and willingness to repeat.
- Being tested
- modified- WIM colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified- WIM colonoscopyProcedure or surgery
Also called modified-water immersion method colonoscopy
Modified-water immersion method of colonoscopy refers to the freely episodic suction of the infused-water during colonoscopy insertion phase at a moment to negotiate the angulated colon to facilitate cecal intubation but not suction the mucosa. The original water immersion method only suctions the water when the colon is over-distended or it is dirty and exchanges it with the new cleans water during insertion then evacuates all of the water during withdrawal
| Study group | Role | What they receive |
|---|---|---|
| modified-WIM colonoscopy in RLP | Experimental | Modified-water immersion method colonoscopy is performed to patients with right-lateral starting position (RLP). Patients will lie in the right lateral position with both hips and knees flexed at the beginning and change the position into supine and at last left-lateral position when it is needed. Receives: Procedure: modified- WIM colonoscopy |
| modified-WIM colonoscopy in LLP | Active comparator | Modified-water immersion method (WIM) colonoscopy is performed to patients with left-lateral starting position (LLP). Patients will lie in the left lateral position with right hip and knee flexed and left leg straight at the beginning and change the position into supine and at last right lateral position when it is needed. Receives: Procedure: modified- WIM colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal discomfort score
The patient reported level of abdominal discomfort experienced during the colonoscopy examination. The patients will punctuate the VAS score line form by themselves, immediately after the end of examination (patient still lying on the examination bed). The VAS will be measured on a linear visual analog scale: 0=none, 10=most severe.
Measured: during the study
Secondary outcomes (4)
Cecal Intubation rate
The proportion of patients with successful insertion of the colonoscope to the cecum with the tip of the colonoscope touching the floor of the cecum with visualization of the medial cecal wall between the ileocecal valve and/or appendix orifice
Measured: during the study
Cecal intubation time
Time need to insert from the anus to the cecum
Measured: during the study
Time needs to pass rectosigmoid
Time needs to pass rectosigmoid is measured from the insertion until to when the colonoscope length passes the 40 cm sign on the colonoscope without looping.
Measured: during the study
Difficulties during colonoscope insertion
Difficulties which are found during colonoscope insertion will be recorded and analyzed (e.g., looping; predominant faecal obstruction visualization level, need to use abdominal compression, need to change from starting position)
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start20 Feb 2018
- Primary completionMar 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
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 Water Immersion Method Colonoscopy in Unsedated PatientsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PUTUT BAYUPURNAMA, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489824
- Sponsor's protocol ID
- PB-WC003
- Acronym
- RLPvsLLP
- Status last verified
- Mar 2018
- First submitted
- 30 Mar 2018
- Last updated
- 6 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bayupurnama P, Ratnasari N, Indrarti F, Triwikatmani C, Maduseno S, Nurdjanah S, W Leung F. The Effectiveness of Right- vs Left-lateral Starting Position in Unsedated Diagnostic Colonoscopy with Modified-water Immersion Method: A Randomized Controlled Trial Study. Clin Exp Gastroenterol. 2020 Sep 24;13:369-375. doi: 10.2147/CEG.S270793. eCollection 2020.
PubMed 33061515
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Right- vs Left-lateral Starting Position in Unsedated Colonoscopy With Modified-Water Immersion Method Colonoscopy
- ClinicalTrials.gov ID
- NCT03489824
- Acronym / sponsor ID
- RLPvsLLP / PB-WC003
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 6 Apr 2018 (actual)
- 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.
Abdominal discomfort is of the most important patient interest when in an unsedated colonoscopy examination. Water method for colonoscopy examination has been studied widely and evidence showed effectiveness in reducing discomfort and increase cecal intubation time and increasing cecal intubation rates in unsedated patients.
Detailed description
Abdominal discomfort is of the most important patient interest when in an unsedated colonoscopy examination. Water method for colonoscopy examination has been studied widely and evidence showed effectiveness in reducing discomfort and increase cecal intubation time and increasing cecal intubation rates in unsedated patients. Our previous studies showed that water immersion method reduced the VAS score, accelerated the intubation time significantly without different changing cecal intubation rate. Previous right-sided vs. left-sided starting position colonoscopy study in sedated patients with air insufflation colonoscopy method showed that right-sided starting position improved the abdominal discomfort score and faster cecal intubation time. We want postulate that the right-sided starting position can also maximize the water method advantages in lowering the discomfort score, faster cecal intubation time and higher cecal intubation rates, and it will improve patient acceptance of water unsedated colonoscopy and willingness to repeat.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified-WIM colonoscopy in RLP | Experimental | Procedure: modified- WIM colonoscopyModified-water immersion method colonoscopy is performed to patients with right-lateral starting position (RLP). Patients will lie in the right lateral position with both hips and knees flexed at the beginning and change the position into supine and at last left-lateral position when it is needed. |
| modified-WIM colonoscopy in LLP | Active comparator | Procedure: modified- WIM colonoscopyModified-water immersion method (WIM) colonoscopy is performed to patients with left-lateral starting position (LLP). Patients will lie in the left lateral position with right hip and knee flexed and left leg straight at the beginning and change the position into supine and at last right lateral position when it is needed. |
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 the 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 the need for diagnostic colonoscopy examination.
Key exclusion criteria (1 listed)
- Patients who refuse to participate, patients with obstructive lesions in the colon distal of the cecum. , patients with experienced colon resection, patients who are hemodynamically unstable, and patients with severe cardiac disorders (such as acute myocardial infarction, unstable angina, malignant arrhythmia, and moderate to severe congestive heart failure ).
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 |
|---|---|---|
| modified- WIM colonoscopyAlso: modified-water immersion method colonoscopyModified-water immersion method of colonoscopy refers to the freely episodic suction of the infused-water during colonoscopy insertion phase at a moment to negotiate the angulated colon to facilitate cecal intubation but not suction the mucosa. The original water immersion method only suctions the water when the colon is over-distended or it is dirty and exchanges it with the new cleans water during insertion then evacuates all of the water during withdrawal | Procedure or surgery | modified-WIM colonoscopy in LLP, modified-WIM colonoscopy in RLP |
Primary outcome
Abdominal discomfort score
Time frame: during the study
The patient reported level of abdominal discomfort experienced during the colonoscopy examination. The patients will punctuate the VAS score line form by themselves, immediately after the end of examination (patient still lying on the examination bed). The VAS will be measured on a linear visual analog scale: 0=none, 10=most severe.
4 secondary outcomes
Cecal Intubation rate
Time frame: during the study
Cecal intubation time
Time frame: during the study
Time needs to pass rectosigmoid
Time frame: during the study
Difficulties during colonoscope insertion
Time frame: during the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Derived from this study: PubMed 33061515Bayupurnama P, Ratnasari N, Indrarti F, Triwikatmani C, Maduseno S, Nurdjanah S, W Leung F. The Effectiveness of Right- vs Left-lateral Starting Position in Unsedated Diagnostic Colonoscopy with Modified-water Immersion Method: A Randomized Controlled Trial Study. Clin Exp Gastroenterol. 2020 Sep 24;13:369-375. doi: 10.2147/CEG.S270793. eCollection 2020.
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 modified- WIM colonoscopy in people with Water Immersion Method Colonoscopy in Unsedated Patients, 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: status not confirmed, as of the sponsor's last update on 6 Apr 2018. 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.
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 PUTUT BAYUPURNAMA, MD (+62274553119, pututby@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal discomfort score (time frame: during the study). 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 NCT03489824, 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 6 Apr 2018.