Colonic AdenomasNCT02178033
The Impact of Split Dose of Low-volume Polyethylene Glycol on Adenoma Detection Rate
A study testing Split dose low-volume PEG solution in people with Colonic Adenomas, run by Valduce Hospital at 2 sites in Italy.
Trial summary
An adequate level of bowel preparation is crucial for the efficacy and safety of colonoscopy. Strong evidences suggest that bowel-preparation quality shows an inverse correlation with length of the interval between the end of cleansing agent intake and the start of colonoscopy (shorter intervals are associated with… Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Colonic Adenomas
- What is being tested?
- Split dose low-volume PEG solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2014to Jan 2015
- 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 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- asymptomatic subjects aged 50-69 participating to regional screening program and undergoing outpatient colonoscopy for positive immunologic fecal occult blood test.
Who cannot join
- patients undergoing colonoscopy as primary screening test
- patients undergoing colonoscopy for symptoms or post-polypectomy/ cancer surveillance
- patients with history of negative large bowel endoscopy within the previous 5 years
- patients with personal history of hereditary syndromes
- patients with history of colonic resection and inflammatory bowel disease
- patients with a history of radiation therapy to abdomen or pelvis
Show all 12Show fewer
- patients with a history of severe cardiovascular, pulmonary, liver or renal disease
- patients with unstable psychiatric illness
- patients at risk for inhalation
- patients on ant-platelet therapy or anticoagulation at the time of endoscopy procedure, preventing polyp resection
- patient with known hypersensitivity or contraindications (i.e., patients with phenylketonuria or glucose-6-phosphate dehydrogenase deficiency) to the study product
- patients who are not able or refuse to provide informed written consent
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale VAlduce, Gastroenterology Unit
Como, 22100
Franco Radaelli, MD, 0039031324145
- Recruiting
IRCCS Istituto Clinico Humanitas; Gastroenterology Unit
Milan, 20100
Alessandro Repici, MD, 00390282241, alessandro.repici@humanitas.it
About this study
Official title: The Impact of Split Dose of Low-volume Polyethylene Glycol on Adenoma Detection Rate: a Randomized, Investigator Blind, Controlled Trial
An adequate level of bowel preparation is crucial for the efficacy and safety of colonoscopy. Strong evidences suggest that bowel-preparation quality shows an inverse correlation with length of the interval between the end of cleansing agent intake and the start of colonoscopy (shorter intervals are associated with better preparation levels). Accordingly, the use of a split-dose administration regimen has been demonstrated to significantly improve the quality of preparation, besides patient acceptability, as compared with standard administration the day before colonoscopy. All randomized controlled trials comparing split versus standard preparations were primarily aimed at assessing the quality of colon cleansing, by means of either validated or not-validated colon cleansing scales. The impact of a split dose regimen on objective colonoscopy performance measures such as adenoma detection rate (ADR) has never been specifically and prospectively evaluated.
The present study is aimed at evaluating whether the split-dose preparation regimen is associated with an increase of adenoma detection.
Read more
For this purpose, asymptomatic subjects aged 50-69, undergoing screening colonoscopy for positive immunologic fecal occult blood test are randomized in a 1:1 ratio to receive low-volume (2L) PEG plus ascorbic acid solution either in a split-dose (study arm) or in a full-dose regimen (control arm).
Treatments are allocated using a computer-generated, randomized code list. The treatment allocation is concealed and is accomplished at the screening visit through non-research personnel who is not involved in the study. To ensure masking, the endoscopists who perform the colonoscopies are not involved in the randomization process and in the pre-procedure data collection.
In this study the the primary outcome measure was the proportion of patients with at least one adenoma (Adenoma Detection Rate) in each harm. Data on bowel cleansing, patient compliance, tolerability and acceptability were also collected.
A sample size of at least 514 patients (257 in each arm) was calculated, by hypothesizing a relative increase of 25% in the adenoma detection rate in the split dose preparation group, assuming a 40% prevalence of one or more adenoma in FIT-positive patients undergoing screening colonoscopy (significance level 0.05, 90% power).
Read the detailed description
All participants will receive the same low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®*, Norgine, Harefield, United Kingdom; each liter containing 100.0 g macrogol 3350, 7.5 g sodium sulfate,2.7 g sodium chloride, 1.0 g potassium chloride, 4.7 g ascorbic acid, 5.9 g sodium ascorbate, and lemon or orange flavoring).
Patients allocated in the "control arm" will receive the whole preparation the day before colonoscopy, whereas, patient randomly allocated to the "active treatment" will take one liter of the bowel preparation the evening before the procedure and the remaining liter the day of the procedure.
Participants will also receive a standardized low-fiber diet before the colonoscopy, avoiding fruit, legumes or vegetables for 3 days before the procedure. They will have a normal breakfast and a light lunch on the day before the procedure, but no solid food will be permitted since then. Liquid food (e.g., clear soup or yoghurt) will be permitted for the evening meal. Clear fluids can be taken at any time, until 2 hours before the procedure.
Treatments are allocated using a computer-generated, randomized code list. The treatment allocation is concealed and is accomplished at the screening visit through non-research personnel who is not involved in the study. To ensure masking, the endoscopists who perform the colonoscopies are not involved in the randomization process and in the pre-procedure data collection.
Data on patient compliance, tolerability and acceptability are collected on the morning of colonoscopy, immediately before the procedure, by a nurse questioned through a standardised questionnaire. The endoscopist is not allowed to take part in the questioning or to supervise the questionnaire.
- Conditions
- Colonic Adenomas
- Being tested
- Split dose low-volume PEG solution
- Keywords
- adenoma detection rate, screening colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split dose low-volume PEG solutionDrug
Also called Low-volumePEG solution used in this study: MOVIPREP®, Norgine, Harefield, United Kingdom
All participants will receive low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®, Norgine, Harefield, United Kingdom); in the "control arm" the whole colonoscopy preparation is administered the day before colonoscopy; in the " active comparator " arm one liter of the bowel preparation is administered on the evening before the colonoscopy and the remaining liter on the day of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| low-volume (2L) PEG | Other | All participants will receive low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®*, Norgine, Harefield, United Kingdom); Bowel cleansing preparation is divided into two equal doses (each MOVIPREP® sachet dissolved in one liter of water, according to manufacturer's instruction). Each dose must be followed by at least 0.5 L of clear fluid at each administration, and should be taken in a maximum time of 2 hours. In this arm, both doses are taken the day before colonoscopy, starting on the evening at about 18:00. Solution intake should be completed before 22.00 h. Receives: Drug: Split dose low-volume PEG solution |
| Split dose low-volume PEG solution | Active comparator | All participants will receive low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®*, Norgine, Harefield, United Kingdom); Bowel cleansing preparation is divided into two equal doses (each MOVIPREP® sachet dissolved in one liter of water, according to manufacturer's instruction). Each dose must be followed by at least 0.5 L of clear fluid at each administration, and should be taken in a maximum time of 2 hours. In this arm, the first dose is taken on the evening before colonoscopy (at about 20:00 h), the second one is taken early in the morning on the day of the procedure, starting about 4 h before the scheduled procedure time. Receives: Drug: Split dose low-volume PEG solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate
Proportion of patients with at least one adenoma
Measured: 1 year
Secondary outcomes (7)
Advanced Adenoma Detection Rate
Number of patients with at least one advanced adenoma (adenoma> or =10mm and/or villous component and/or high grade dysplasia)
Measured: 1 year
Flat/depressed Adenoma Detection Rate
proportion of patients with at least one flat/depressed adenoma
Measured: 1 year
Proximal sessile serrated lesion detection rate
Proportion of patients with at least one proximal sessile serrated lesion
Measured: 1 year
Number of adenomas per patient
Number of adenomas per patient
Measured: 1 year
Number of advanced adenomas per patient
Number of advanced adenomas per patient
Measured: 1 year
Number of proximal adenomas
Number of adenomas located in the proximal colon (right and transverse colon)
Measured: 1 year
Quality of bowel preparation
Quality of bowel cleansing measured by the Boston Bowel Preparation Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionJan 2015 (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 Colonic AdenomasStudies 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
- 514 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Clinico Humanitas, Istituti Ospitalieri di Cremona, Nuovo Regina Margherita Hospital
- Responsible party
- Principal investigator, Franco Radaelli, Valduce Hospital
- Investigators
- Franco Radaelli, MD, Principal investigator, Ospedale Valduce, Gastroenterology Unit, Via Dante 10, 22100, Como, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178033
- Sponsor's protocol ID
- Split dose-ADR
- Status last verified
- Jun 2014
- First submitted
- 25 Jun 2014
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Radaelli F, Paggi S, Hassan C, Senore C, Fasoli R, Anderloni A, Buffoli F, Savarese MF, Spinzi G, Rex DK, Repici A. Split-dose preparation for colonoscopy increases adenoma detection rate: a randomised controlled trial in an organised screening programme. Gut. 2017 Feb;66(2):270-277. doi: 10.1136/gutjnl-2015-310685. Epub 2015 Dec 9.
PubMed 26657900
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Split Dose of Low-volume Polyethylene Glycol on Adenoma Detection Rate: a Randomized, Investigator Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT02178033
- Acronym / sponsor ID
- Split dose-ADR
- Conditions
- Colonic Adenomas
- Keywords
- adenoma detection rate, screening colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 514 participants (estimated)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Collaborators
- Istituto Clinico Humanitas, Istituti Ospitalieri di Cremona, Nuovo Regina Margherita Hospital
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 30 Jun 2014 (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.
An adequate level of bowel preparation is crucial for the efficacy and safety of colonoscopy. Strong evidences suggest that bowel-preparation quality shows an inverse correlation with length of the interval between the end of cleansing agent intake and the start of colonoscopy (shorter intervals are associated with better preparation levels). Accordingly, the use of a split-dose administration regimen has been demonstrated to significantly improve the quality of preparation, besides patient acceptability, as compared with standard administration the day before colonoscopy. All randomized controlled trials comparing split versus standard preparations were primarily aimed at assessing the quality of colon cleansing, by means of either validated or not-validated colon cleansing scales. The impact of a split dose regimen on objective colonoscopy performance measures such as adenoma detection rate (ADR) has never been specifically and prospectively evaluated.
The present study is aimed at evaluating whether the split-dose preparation regimen is associated with an increase of adenoma detection.
For this purpose, asymptomatic subjects aged 50-69, undergoing screening colonoscopy for positive immunologic fecal occult blood test are randomized in a 1:1 ratio to receive low-volume (2L) PEG plus ascorbic acid solution either in a split-dose (study arm) or in a full-dose regimen (control arm).
Treatments are allocated using a computer-generated, randomized code list. The treatment allocation is concealed and is accomplished at the screening visit through non-research personnel who is not involved in the study. To ensure masking, the endoscopists who perform the colonoscopies are not involved in the randomization process and in the pre-procedure data collection.
In this study the the primary outcome measure was the proportion of patients with at least one adenoma (Adenoma Detection Rate) in each harm. Data on bowel cleansing, patient compliance, tolerability and acceptability were also collected.
A sample size of at least 514 patients (257 in each arm) was calculated, by hypothesizing a relative increase of 25% in the adenoma detection rate in the split dose preparation group, assuming a 40% prevalence of one or more adenoma in FIT-positive patients undergoing screening colonoscopy (significance level 0.05, 90% power).
Detailed description
All participants will receive the same low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®*, Norgine, Harefield, United Kingdom; each liter containing 100.0 g macrogol 3350, 7.5 g sodium sulfate,2.7 g sodium chloride, 1.0 g potassium chloride, 4.7 g ascorbic acid, 5.9 g sodium ascorbate, and lemon or orange flavoring).
Patients allocated in the "control arm" will receive the whole preparation the day before colonoscopy, whereas, patient randomly allocated to the "active treatment" will take one liter of the bowel preparation the evening before the procedure and the remaining liter the day of the procedure.
Participants will also receive a standardized low-fiber diet before the colonoscopy, avoiding fruit, legumes or vegetables for 3 days before the procedure. They will have a normal breakfast and a light lunch on the day before the procedure, but no solid food will be permitted since then. Liquid food (e.g., clear soup or yoghurt) will be permitted for the evening meal. Clear fluids can be taken at any time, until 2 hours before the procedure.
Treatments are allocated using a computer-generated, randomized code list. The treatment allocation is concealed and is accomplished at the screening visit through non-research personnel who is not involved in the study. To ensure masking, the endoscopists who perform the colonoscopies are not involved in the randomization process and in the pre-procedure data collection.
Data on patient compliance, tolerability and acceptability are collected on the morning of colonoscopy, immediately before the procedure, by a nurse questioned through a standardised questionnaire. The endoscopist is not allowed to take part in the questioning or to supervise the questionnaire.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-volume (2L) PEG | Other | Drug: Split dose low-volume PEG solutionAll participants will receive low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®*, Norgine, Harefield, United Kingdom); Bowel cleansing preparation is divided into two equal doses (each MOVIPREP® sachet dissolved in one liter of water, according to manufacturer's instruction). Each dose must be followed by at least 0.5 L of clear fluid at each administration, and should be taken in a maximum time of 2 hours. In this arm, both doses are taken the day before colonoscopy, starting on the evening at about 18:00. Solution intake should be completed before 22.00 h. |
| Split dose low-volume PEG solution | Active comparator | Drug: Split dose low-volume PEG solutionAll participants will receive low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®*, Norgine, Harefield, United Kingdom); Bowel cleansing preparation is divided into two equal doses (each MOVIPREP® sachet dissolved in one liter of water, according to manufacturer's instruction). Each dose must be followed by at least 0.5 L of clear fluid at each administration, and should be taken in a maximum time of 2 hours. In this arm, the first dose is taken on the evening before colonoscopy (at about 20:00 h), the second one is taken early in the morning on the day of the procedure, starting about 4 h before the scheduled procedure time. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- asymptomatic subjects aged 50-69 participating to regional screening program and undergoing outpatient colonoscopy for positive immunologic fecal occult blood test.
Key exclusion criteria (12 listed)
- patients undergoing colonoscopy as primary screening test
- patients undergoing colonoscopy for symptoms or post-polypectomy/ cancer surveillance
- patients with history of negative large bowel endoscopy within the previous 5 years
- patients with personal history of hereditary syndromes
- patients with history of colonic resection and inflammatory bowel disease
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 |
|---|---|---|
| Split dose low-volume PEG solutionAlso: Low-volumePEG solution used in this study: MOVIPREP®, Norgine, Harefield, United KingdomAll participants will receive low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®, Norgine, Harefield, United Kingdom); in the "control arm" the whole colonoscopy preparation is administered the day before colonoscopy; in the " active comparator " arm one liter of the bowel preparation is administered on the evening before the colonoscopy and the remaining liter on the day of the procedure. | Drug | Split dose low-volume PEG solution, low-volume (2L) PEG |
Primary outcome
Adenoma Detection Rate
Time frame: 1 year
Proportion of patients with at least one adenoma
7 secondary outcomes
Advanced Adenoma Detection Rate
Time frame: 1 year
Flat/depressed Adenoma Detection Rate
Time frame: 1 year
Proximal sessile serrated lesion detection rate
Time frame: 1 year
Number of adenomas per patient
Time frame: 1 year
Number of advanced adenomas per patient
Time frame: 1 year
Number of proximal adenomas
Time frame: 1 year
Quality of bowel preparation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Derived from this study: PubMed 26657900Radaelli F, Paggi S, Hassan C, Senore C, Fasoli R, Anderloni A, Buffoli F, Savarese MF, Spinzi G, Rex DK, Repici A. Split-dose preparation for colonoscopy increases adenoma detection rate: a randomised controlled trial in an organised screening programme. Gut. 2017 Feb;66(2):270-277. doi: 10.1136/gutjnl-2015-310685. Epub 2015 Dec 9.
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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.
Franco Radaelli, MD principal investigator
Ospedale Valduce, Gastroenterology Unit, Via Dante 10, 22100, Como, Italy.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split dose low-volume PEG solution in people with Colonic Adenomas, run by Valduce Hospital at 2 sites in Italy.
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 12 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 30 Jun 2014. 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 Italy. 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 Franco Radaelli, MD (0039031324145, francoradaelli01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Detection Rate (time frame: 1 year). 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 NCT02178033, 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 30 Jun 2014.