Bowel Preparation for ColonoscopyPhase 4NCT01853709
Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients
A Phase 4 study testing Education, Fiber free diet and Adjuvants in people with Bowel Preparation for Colonoscopy, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Colonoscopy is the gold standard diagnostic procedure for colonic disease. Excellent bowel cleansing is critical for this procedure. However, an inadequate bowel cleansing is a common problem that occurs up to 20% of procedures. This fact has a deep clinical and economical impact. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- Education, Fiber free diet and Adjuvants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSpain
- Study dates
- May 2013to Dec 2013
- 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
- Hospitalized patients who undergo a non urgent colonoscopy
- Patients who give informed consent to participate in the study
- Patients older than 18 years
- Patients who undergo total colonoscopy
Who cannot join
- Non compliance with the 48 hours diet prescribed
- The endoscopy planned is a rectosigmoidoscopy
- Previous colonic surgery
- Mental/cognitive impairment preventing the study assessments
- Severe renal failure
- Electrolytic disbalance(hyponatremia, hypokaliemia, Hyperphosphatemia, hypocalcemia and hypomagnesemia)
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- Intestinal obstruction, perforation or toxic megacolon
- Pregnant or nursing women
- Allergy/intolerance to PEG, bisacodyl or adjuvants
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients. A Randomized Controlled Trial
Colonoscopy is the gold standard diagnostic procedure for colonic disease. Excellent bowel cleansing is critical for this procedure. However, an inadequate bowel cleansing is a common problem that occurs up to 20% of procedures. This fact has a deep clinical and economical impact. In fact, inadequate bowel preparation is associated to misdiagnosis in 30% of lesions. Moreover several clinical conditions such as cirrhosis, antidepressant drugs, and hospitalized patients are predictive factors of inadequate colonic preparations. These circumstances have promoted multiple clinical trials, however there is no consensus about the optimal strategy for colonic cleansing. Education in colonic preparation has obtained conflicting results. Polyethylene glycol (PEG) and sodium phosphate solutions have been the commonest preparations used with a similar efficacy. However, the large volume to ingest (4 litters) makes PEG compliance difficult. Likewise, sodium phosphate also contains high levels in sodium and phosphate which contraindicate its use in elderly patients and / or with comorbidity. The use of adjuvants such as olive oil and bisacodyl allows reducing the volume of polyethylene glycol thereby improving the tolerance and right colon preparation.
The aim of this study is to compare the efficacy of a multidisciplinary approach (education, fiber free diet, polyethylene glycol (PEG) 2L, and adjuvant bisacodyl + olive oil) vs. a conventional approach (fiber free diet+ PEG 4L in split doses ) in cleaning the colon of hospitalized patients.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- Education, Fiber free diet, Adjuvants, Polyethylene glycol (PEG), Bisacodyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Fiber free dietOther
AdjuvantsDietary supplement
Polyethylene glycol (PEG)Drug
BisacodylDrug
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary approach | Experimental | The multidisciplinary approach will include:
Education Fiber free diet Bisacodyl: 10 mg 2 days before the procedure, 20 mg the day before the procedure and 10 mg 3 hours before the procedure Adjuvants: Olive Oil:60 mL/Apple Juice: 200 mL PEG: 1 L the night before the procedure and 1 L 3 hours before the procedure Receives: Behavioral: Education; Other: Fiber free diet; Dietary Supplement: Adjuvants; Drug: Polyethylene glycol (PEG); Drug: Bisacodyl |
| Conventional approach | Active comparator | The conventional approach will include:
Education Fiber free diet Polyethylene glycol (PEG): 2 L the night before the procedure, 2 L 3 hours before the procedure Receives: Behavioral: Education; Other: Fiber free diet; Drug: Polyethylene glycol (PEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with adequate bowel preparation
Adequate bowel preparation is defined as a preparation which allows exploring the whole colonic mucose and detecting flat lesions (Rating as good or excellent in the Boston Bowel preparation scale)
Measured: at the time of performing the colonoscopy
Secondary outcomes (7)
Percentage of patients with adequate bowel preparation by bowel segments
The boston scale will be assessed by the investigators during the procedure.
Measured: At the time of performing the colonoscopy
Tolerance to the colonoscopy
Tolerance to the colonoscopy will be measured by VAS during the colonoscopy, 30 minutes after colonoscopy and 24 hours after colonoscopy
Measured: from colonoscopy up to 24 hours after colonoscopy
Percentage of complete/incomplete colonoscopies and reprogramming
Evaluation of incomplete or inadequate bowel preparation will be assessed after performing the colonoscopy
Measured: After the colonoscopy
Complications during and after the procedure
Measured: up to 24 hours after colonoscopy
Doses of sedation needed during the colonoscopy
Final dose will be calculated at the end of the procedure
Measured: During the colonoscopy process
Tolerance to the preparation
Measured: up to 48 hours
Endoscopic findings
Measured: during the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Junquera, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853709
- Sponsor's protocol ID
- CSPT-END-DIG-2012
- Status last verified
- May 2013
- First submitted
- 29 Apr 2013
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01853709
- Acronym / sponsor ID
- CSPT-END-DIG-2012
- Conditions
- Bowel Preparation for Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 May 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.
Colonoscopy is the gold standard diagnostic procedure for colonic disease. Excellent bowel cleansing is critical for this procedure. However, an inadequate bowel cleansing is a common problem that occurs up to 20% of procedures. This fact has a deep clinical and economical impact. In fact, inadequate bowel preparation is associated to misdiagnosis in 30% of lesions. Moreover several clinical conditions such as cirrhosis, antidepressant drugs, and hospitalized patients are predictive factors of inadequate colonic preparations. These circumstances have promoted multiple clinical trials, however there is no consensus about the optimal strategy for colonic cleansing. Education in colonic preparation has obtained conflicting results. Polyethylene glycol (PEG) and sodium phosphate solutions have been the commonest preparations used with a similar efficacy. However, the large volume to ingest (4 litters) makes PEG compliance difficult. Likewise, sodium phosphate also contains high levels in sodium and phosphate which contraindicate its use in elderly patients and / or with comorbidity. The use of adjuvants such as olive oil and bisacodyl allows reducing the volume of polyethylene glycol thereby improving the tolerance and right colon preparation.
The aim of this study is to compare the efficacy of a multidisciplinary approach (education, fiber free diet, polyethylene glycol (PEG) 2L, and adjuvant bisacodyl + olive oil) vs. a conventional approach (fiber free diet+ PEG 4L in split doses ) in cleaning the colon of hospitalized patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary approach | Experimental | Behavioral: Education, Other: Fiber free diet, Dietary Supplement: Adjuvants, Drug: Polyethylene glycol (PEG), Drug: BisacodylThe multidisciplinary approach will include: Education Fiber free diet Bisacodyl: 10 mg 2 days before the procedure, 20 mg the day before the procedure and 10 mg 3 hours before the procedure Adjuvants: Olive Oil:60 mL/Apple Juice: 200 mL PEG: 1 L the night before the procedure and 1 L 3 hours before the procedure |
| Conventional approach | Active comparator | Behavioral: Education, Other: Fiber free diet, Drug: Polyethylene glycol (PEG)The conventional approach will include: Education Fiber free diet Polyethylene glycol (PEG): 2 L the night before the procedure, 2 L 3 hours before the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized patients who undergo a non urgent colonoscopy
- Patients who give informed consent to participate in the study
- Patients older than 18 years
- Patients who undergo total colonoscopy
Key exclusion criteria (10 listed)
- Non compliance with the 48 hours diet prescribed
- The endoscopy planned is a rectosigmoidoscopy
- Previous colonic surgery
- Mental/cognitive impairment preventing the study assessments
- Severe renal 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 |
|---|---|---|
| Education | Behavioural | Conventional approach, Multidisciplinary approach |
| Fiber free diet | Other | Conventional approach, Multidisciplinary approach |
| Adjuvants | Dietary supplement | Multidisciplinary approach |
| Polyethylene glycol (PEG) | Drug | Conventional approach, Multidisciplinary approach |
| Bisacodyl | Drug | Multidisciplinary approach |
Primary outcome
percentage of patients with adequate bowel preparation
Time frame: at the time of performing the colonoscopy
Adequate bowel preparation is defined as a preparation which allows exploring the whole colonic mucose and detecting flat lesions (Rating as good or excellent in the Boston Bowel preparation scale)
7 secondary outcomes
Percentage of patients with adequate bowel preparation by bowel segments
Time frame: At the time of performing the colonoscopy
Tolerance to the colonoscopy
Time frame: from colonoscopy up to 24 hours after colonoscopy
Percentage of complete/incomplete colonoscopies and reprogramming
Time frame: After the colonoscopy
Complications during and after the procedure
Time frame: up to 24 hours after colonoscopy
Doses of sedation needed during the colonoscopy
Time frame: During the colonoscopy process
Tolerance to the preparation
Time frame: up to 48 hours
Endoscopic findings
Time frame: during the colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
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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.
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 Education, Fiber free diet and Adjuvants in people with Bowel Preparation for Colonoscopy, run by Corporacion Parc Tauli at 1 site in Spain.
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 10 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 15 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 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Félix Junquera, PhD (34937458320, fjunquera@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with adequate bowel preparation (time frame: at the time of performing the colonoscopy). 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 15 May 2013.