Bowel Cleansing for ColonoscopyNCT01624454
Optimal Bowel Cleansing Trial
A study testing Laxabon and CitraFleet in people with Bowel Cleansing for Colonoscopy, run by Helse Stavanger HF at 2 sites in Norway.
Trial summary
Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bowel Cleansing for Colonoscopy
- What is being tested?
- Laxabon and CitraFleet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 2 sitesNorway
- Study dates
- Apr 2012to Dec 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pts for out-patient colonoscopy
- age 18-80
Who cannot join
- Active colitis or suspicion thereof (bloody diarrhea, fever and abdominal pain)
- Suspicion of renal insufficiency or ileus/subileus
- Previous colonic surgery
- Pregnancy
- Inability to adhere to cleansing instructions
- Inability to consent
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Sørlandet sykehus
Kristiansand, VestAgder
OUS Rikshospitalet, dept of med gastro
Oslo, Oslo
About this study
Official title: Osmotic or Large Volume Lavage for Optimal Bowel Preparation - a Single-blind Randomized Trial
Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter
Read the detailed description
This randomized quality assurance trial aims to compare cleansing quality of two different principles of colonoscopy lavage. Large volume PEG solutions are considered safe, but cumbersome and inpalatable, while osmotic solutions are generally more acceptable, however, the risk of electrolyte disturbances or renal decompensation may increase.
The study will focus on patient experience and compliance, as well as cleansing quality, endoscopic findings and other technical parameters of the colonoscopy procedure that may be adversely affected by poor bowel cleansing. Three centers will participate, ensuring a diverse patient population. 800 patients are planned for recruitment, but an interim assessment of statistics of the primary aim parameter (bowel cleansing) will be performed to adjust the number.
- Conditions
- Bowel Cleansing for Colonoscopy
- Being tested
- Laxabon, CitraFleet
- Keywords
- colonoscopy, bowel cleansing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaxabonOther
4 l PEG solution split dose cleansing
CitraFleetOther
Small volume osmotic bowelcleansing
| Study group | Role | What they receive |
|---|---|---|
| large volume | Active comparator | bowel cleansing with PEG Receives: Other: Laxabon |
| Osmotic | Active comparator | Not described Receives: Other: CitraFleet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel cleansing quality
Measured: 1 Day
Secondary outcomes (1)
Colonoscopy findings
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
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 Bowel Cleansing for 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lars Aabakken, prof of med, Principal investigator, Prof of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624454
- Sponsor's protocol ID
- SUS-CRAP
- Status last verified
- Jun 2012
- First submitted
- 18 Jun 2012
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Leitao K, Grimstad T, Bretthauer M, Holme O, Paulsen V, Karlsen L, Isaksen K, Cvancarova M, Aabakken L. Polyethylene glycol vs sodium picosulfate/magnesium citrate for colonoscopy preparation. Endosc Int Open. 2014 Dec;2(4):E230-4. doi: 10.1055/s-0034-1377520. Epub 2014 Oct 24.
PubMed 26135098
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osmotic or Large Volume Lavage for Optimal Bowel Preparation - a Single-blind Randomized Trial
- ClinicalTrials.gov ID
- NCT01624454
- Acronym / sponsor ID
- SUS-CRAP
- Conditions
- Bowel Cleansing for Colonoscopy
- Keywords
- colonoscopy, bowel cleansing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Jun 2012 (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.
Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter
Detailed description
This randomized quality assurance trial aims to compare cleansing quality of two different principles of colonoscopy lavage. Large volume PEG solutions are considered safe, but cumbersome and inpalatable, while osmotic solutions are generally more acceptable, however, the risk of electrolyte disturbances or renal decompensation may increase.
The study will focus on patient experience and compliance, as well as cleansing quality, endoscopic findings and other technical parameters of the colonoscopy procedure that may be adversely affected by poor bowel cleansing. Three centers will participate, ensuring a diverse patient population. 800 patients are planned for recruitment, but an interim assessment of statistics of the primary aim parameter (bowel cleansing) will be performed to adjust the number.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| large volume | Active comparator | Other: Laxabonbowel cleansing with PEG |
| Osmotic | Active comparator | Other: CitraFleet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pts for out-patient colonoscopy
- age 18-80
Key exclusion criteria (6 listed)
- Active colitis or suspicion thereof (bloody diarrhea, fever and abdominal pain)
- Suspicion of renal insufficiency or ileus/subileus
- Previous colonic surgery
- Pregnancy
- Inability to adhere to cleansing instructions
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 |
|---|---|---|
| Laxabon4 l PEG solution split dose cleansing | Other | large volume |
| CitraFleetSmall volume osmotic bowelcleansing | Other | Osmotic |
Primary outcome
Bowel cleansing quality
Time frame: 1 Day
1 secondary outcome
Colonoscopy findings
Time frame: 1 Day
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 9 May 2013.
- Derived from this study: PubMed 26135098Leitao K, Grimstad T, Bretthauer M, Holme O, Paulsen V, Karlsen L, Isaksen K, Cvancarova M, Aabakken L. Polyethylene glycol vs sodium picosulfate/magnesium citrate for colonoscopy preparation. Endosc Int Open. 2014 Dec;2(4):E230-4. doi: 10.1055/s-0034-1377520. Epub 2014 Oct 24.
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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.
Lars Aabakken, prof of med principal investigator
Prof of medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laxabon and CitraFleet in people with Bowel Cleansing for Colonoscopy, run by Helse Stavanger HF at 2 sites in Norway.
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 2 inclusion and 6 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 9 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Bowel cleansing quality (time frame: 1 Day). 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 NCT01624454, 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 9 May 2013.