EndoscopyPhase 4NCT00677794
Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination
A Phase 4 study testing Clear fluids, Picosalax and Polyethylene glycol in people with Endoscopy, run by Queen's University at 1 site in Canada.
Trial summary
There remains debate regarding whether small bowel cleansing is required prior to video capsule endoscopy, and if so, which method is best. This study prospectively tests cleansing with no preparation, preparation with picosalax, and preparation with polyethylene glycol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopy
- What is being tested?
- Clear fluids, Picosalax and Polyethylene glycol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Jun 2015
- Phase
- Phase 4
- 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
- patients undergoing VCE.
Who cannot join
- bowel obstruction or ileus;
- known stricture or fistula;
- previous small bowel surgery;
- severe gastroparesis or motility disorder
- renal impairment (serum creatinine over normal range within three months of study);
- congestive heart failure;
Show all 9Show fewer
- cirrhosis;
- implanted cardiac pacemaker or defibrillator or other electromedical device;
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination: a Randomized, Blinded, Controlled Trial
There remains debate regarding whether small bowel cleansing is required prior to video capsule endoscopy, and if so, which method is best. This study prospectively tests cleansing with no preparation, preparation with picosalax, and preparation with polyethylene glycol.
- Conditions
- Endoscopy
- Being tested
- Clear fluids, Picosalax, Polyethylene glycol
- Keywords
- Video Capsule Endoscopy, Small Bowel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear fluidsDrug
Clear fluids only after lunch.
PicosalaxDrug
Two sachets the evening prior to Video Capsule Endoscopy (VCE).
Polyethylene glycolDrug
Two (2) litres the evening prior to Video Capsule Endoscopy (VCE).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Clear fluids only after lunch. Receives: Drug: Clear fluids |
| 2 | Active comparator | Two sachets of picosalax the evening prior to Video Capsule Endoscopy (VCE). Receives: Drug: Picosalax |
| 3 | Active comparator | Polyethylene glycol, 2 liters the evening prior to Video Capsule Endoscopy (VCE). Receives: Drug: Polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
small bowel cleansing
Measured: during exam
Secondary outcomes (3)
yield of Video Capsule Endoscopy (VCE) in iron deficiency
Measured: during study
tolerance of preparation
Measured: during preparation
effect of preparation on blood chemistry
Measured: 24 hours after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2013
- 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 EndoscopyStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Responsible party
- Principal investigator, Dr. Lawrence Hookey, Queen's University
- Investigators
- Lawrence Hookey, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677794
- Sponsor's protocol ID
- small bowel cleansing and VCE
- Status last verified
- Sep 2015
- First submitted
- 13 May 2008
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hookey L, Louw J, Wiepjes M, Rubinger N, Van Weyenberg S, Day AG, Paterson W. Lack of benefit of active preparation compared with a clear fluid-only diet in small-bowel visualization for video capsule endoscopy: results of a randomized, blinded, controlled trial. Gastrointest Endosc. 2017 Jan;85(1):187-193. doi: 10.1016/j.gie.2016.07.028. Epub 2016 Jul 21.
PubMed 27451294
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination: a Randomized, Blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT00677794
- Acronym / sponsor ID
- small bowel cleansing and VCE
- Conditions
- Endoscopy
- Keywords
- Video Capsule Endoscopy, Small Bowel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Study start
- Mar 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 May 2008 (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.
There remains debate regarding whether small bowel cleansing is required prior to video capsule endoscopy, and if so, which method is best. This study prospectively tests cleansing with no preparation, preparation with picosalax, and preparation with polyethylene glycol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Clear fluidsClear fluids only after lunch. |
| 2 | Active comparator | Drug: PicosalaxTwo sachets of picosalax the evening prior to Video Capsule Endoscopy (VCE). |
| 3 | Active comparator | Drug: Polyethylene glycolPolyethylene glycol, 2 liters the evening prior to Video Capsule Endoscopy (VCE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing VCE.
Key exclusion criteria (9 listed)
- bowel obstruction or ileus;
- known stricture or fistula;
- previous small bowel surgery;
- severe gastroparesis or motility disorder
- renal impairment (serum creatinine over normal range within three months of study);
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 |
|---|---|---|
| Clear fluidsClear fluids only after lunch. | Drug | 1 |
| PicosalaxTwo sachets the evening prior to Video Capsule Endoscopy (VCE). | Drug | 2 |
| Polyethylene glycolTwo (2) litres the evening prior to Video Capsule Endoscopy (VCE). | Drug | 3 |
Primary outcome
small bowel cleansing
Time frame: during exam
3 secondary outcomes
yield of Video Capsule Endoscopy (VCE) in iron deficiency
Time frame: during study
tolerance of preparation
Time frame: during preparation
effect of preparation on blood chemistry
Time frame: 24 hours after ingestion
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 25 Sep 2015.
- Derived from this study: PubMed 27451294Hookey L, Louw J, Wiepjes M, Rubinger N, Van Weyenberg S, Day AG, Paterson W. Lack of benefit of active preparation compared with a clear fluid-only diet in small-bowel visualization for video capsule endoscopy: results of a randomized, blinded, controlled trial. Gastrointest Endosc. 2017 Jan;85(1):187-193. doi: 10.1016/j.gie.2016.07.028. Epub 2016 Jul 21.
Related trials for Endoscopy
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
RecruitingObservational study
Outcomes of Knife-Assisted Full-Thickness Resection for Rectal Lesions: A Multicenter Study
Colorectal Cancer
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.
Lawrence Hookey, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clear fluids, Picosalax and Polyethylene glycol in people with Endoscopy, run by Queen's University at 1 site in Canada.
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 9 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 25 Sep 2015. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
small bowel cleansing (time frame: during exam). 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 NCT00677794, 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 25 Sep 2015.