Inflammatory Bowel DiseaseNCT01933867
Water-aided Colonoscopy in Inflammatory Bowel Disease Patients
A study testing Water immersion and Air insufflation insertion in people with Inflammatory Bowel Disease, run by Vitkovice Hospital at 1 site in Czechia.
Trial summary
Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of lower discomfort and need for sedation during colonoscopy. Patients with inflammatory bowel diseases (IBD) undergo repeated colonoscopy in course of their disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Water immersion and Air insufflation insertion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2013to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- known diagnosis of inflammatory bowel disease
- planned diagnostic outpatient colonoscopy
- signed informed consent
- willingness to undergo unsedated colonoscopy
Who cannot join
- ulcerative proctitis
- bowel resection longer than ileocecal resection
- requirement for sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Water-aided Colonoscopy in Patients With Inflammatory Bowel Disease - a Single-center, Single-blinded Randomized Trial
Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of lower discomfort and need for sedation during colonoscopy. Patients with inflammatory bowel diseases (IBD) undergo repeated colonoscopy in course of their disease. According to our preliminary experience, water immersion could be beneficial while scoping these patients. As far as the investigators know, water-aided colonoscopy has never been studied in this indication. Results of our trial might support use of water-aided colonoscopy in common practice and decrease associated discomfort in IBD patients.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Water immersion, Air insufflation insertion
- Keywords
- water, colonoscopy, Crohn´s disease, ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water immersionProcedure or surgery
Water immersion means infusion of room temperature water during colonoscope insertion without air insufflation.
Air insufflation insertionProcedure or surgery
Also called Room air insufflation during colonoscope insertion.
| Study group | Role | What they receive |
|---|---|---|
| Water immersion colonoscopy | Experimental | Water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. Receives: Procedure: Water immersion |
| Air insufflation colonoscopy | Active comparator | Standard room air insufflation during both colonoscope insertion and withdrawal. Receives: Procedure: Air insufflation insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of unsedated colonoscopy
Successful unsedated colonoscopy is defined as reaching the cecum by using given insertion technique without administering sedation.
Measured: at the end of each colonoscopy
Secondary outcomes (2)
Discomfort during colonoscopy
Discomfort level using visual continuous scale 0-10 (0 = no pain, 10 = worst pain).
Measured: at the end of each colonoscopy
Cecal intubation time
Cecal intubation time is defined as time between colonoscope introduction into the anus and reaching the cecum.
Measured: while reaching the cecum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
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 Inflammatory Bowel DiseaseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitkovice Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Premysl Falt MD, Vitkovice Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933867
- Sponsor's protocol ID
- DDC VN 06
- Status last verified
- Jun 2014
- First submitted
- 28 Aug 2013
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Falt P, Smajstrla V, Fojtik P, Urban O, Hill M. Water-Aided Colonoscopy in Inflammatory Bowel Disease Patients-A Randomised, Single-Centre Trial. J Crohns Colitis. 2015 Sep;9(9):720-4. doi: 10.1093/ecco-jcc/jjv093. Epub 2015 Jun 3.
PubMed 26040317
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water-aided Colonoscopy in Patients With Inflammatory Bowel Disease - a Single-center, Single-blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT01933867
- Acronym / sponsor ID
- DDC VN 06
- Conditions
- Inflammatory Bowel Disease
- Keywords
- water, colonoscopy, Crohn´s disease, ulcerative colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Vitkovice HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 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.
Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of lower discomfort and need for sedation during colonoscopy. Patients with inflammatory bowel diseases (IBD) undergo repeated colonoscopy in course of their disease. According to our preliminary experience, water immersion could be beneficial while scoping these patients. As far as the investigators know, water-aided colonoscopy has never been studied in this indication. Results of our trial might support use of water-aided colonoscopy in common practice and decrease associated discomfort in IBD patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water immersion colonoscopy | Experimental | Procedure: Water immersionWater immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
| Air insufflation colonoscopy | Active comparator | Procedure: Air insufflation insertionStandard room air insufflation during both colonoscope insertion and withdrawal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- known diagnosis of inflammatory bowel disease
- planned diagnostic outpatient colonoscopy
- signed informed consent
- willingness to undergo unsedated colonoscopy
Key exclusion criteria (3 listed)
- ulcerative proctitis
- bowel resection longer than ileocecal resection
- requirement for sedation
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 immersionWater immersion means infusion of room temperature water during colonoscope insertion without air insufflation. | Procedure or surgery | Water immersion colonoscopy |
| Air insufflation insertionAlso: Room air insufflation during colonoscope insertion. | Procedure or surgery | Air insufflation colonoscopy |
Primary outcome
Success rate of unsedated colonoscopy
Time frame: at the end of each colonoscopy
Successful unsedated colonoscopy is defined as reaching the cecum by using given insertion technique without administering sedation.
2 secondary outcomes
Discomfort during colonoscopy
Time frame: at the end of each colonoscopy
Cecal intubation time
Time frame: while reaching the cecum
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 18 Nov 2014.
- Derived from this study: PubMed 26040317Falt P, Smajstrla V, Fojtik P, Urban O, Hill M. Water-Aided Colonoscopy in Inflammatory Bowel Disease Patients-A Randomised, Single-Centre Trial. J Crohns Colitis. 2015 Sep;9(9):720-4. doi: 10.1093/ecco-jcc/jjv093. Epub 2015 Jun 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water immersion and Air insufflation insertion in people with Inflammatory Bowel Disease, run by Vitkovice Hospital at 1 site in Czechia.
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 4 inclusion and 3 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 18 Nov 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 Czechia. 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?
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?
Success rate of unsedated colonoscopy (time frame: at the end of each colonoscopy). 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 NCT01933867, 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 18 Nov 2014.