- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02178033
The Impact of Split Dose of Low-volume Polyethylene Glycol on Adenoma Detection Rate
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.
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Como, Italy, 22100
- Recruiting
- Ospedale VAlduce, Gastroenterology Unit
-
Contact:
- Franco Radaelli, MD
- Phone Number: 0039031324145
-
Milano, Italy, 20100
- Recruiting
- IRCCS Istituto Clinico Humanitas; Gastroenterology Unit
-
Contact:
- Alessandro Repici, MD
- Phone Number: 00390282241
- Email: alessandro.repici@humanitas.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- asymptomatic subjects aged 50-69 participating to regional screening program and undergoing outpatient colonoscopy for positive immunologic fecal occult blood test.
Exclusion criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: low-volume (2L) PEG
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.
|
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.
Other Names:
|
Active Comparator: Split dose low-volume PEG solution
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adenoma Detection Rate
Time Frame: 1 year
|
Proportion of patients with at least one adenoma
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Advanced Adenoma Detection Rate
Time Frame: 1 year
|
Number of patients with at least one advanced adenoma (adenoma> or =10mm and/or villous component and/or high grade dysplasia)
|
1 year
|
Flat/depressed Adenoma Detection Rate
Time Frame: 1 year
|
proportion of patients with at least one flat/depressed adenoma
|
1 year
|
Proximal sessile serrated lesion detection rate
Time Frame: 1 year
|
Proportion of patients with at least one proximal sessile serrated lesion
|
1 year
|
Number of adenomas per patient
Time Frame: 1 year
|
Number of adenomas per patient
|
1 year
|
Number of advanced adenomas per patient
Time Frame: 1 year
|
Number of advanced adenomas per patient
|
1 year
|
Number of proximal adenomas
Time Frame: 1 year
|
Number of adenomas located in the proximal colon (right and transverse colon)
|
1 year
|
Quality of bowel preparation
Time Frame: 1 year
|
Quality of bowel cleansing measured by the Boston Bowel Preparation Scale
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Franco Radaelli, MD, Ospedale Valduce, Gastroenterology Unit, Via Dante 10, 22100, Como, Italy.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Split dose-ADR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colonic Adenomas
-
Chinese University of Hong KongCompleted
-
Martin-Luther-Universität Halle-WittenbergUniversity of Ulm; Deutsche Krebshilfe e.V., Bonn (Germany); KKS NetzwerkCompletedColorectal Serrated Adenomas | Colorectal Tubular Adenomas | Colorectal Villous Adenomas | Colorectal Tubulovillous AdenomasGermany
-
Professor Michael BourkeActive, not recruiting
-
Valduce HospitalUnknown
-
Professor Michael BourkeCompleted
-
Changhai HospitalWuhan Union Hospital, China; Wenzhou Central Hospital; The First Affiliated Hospital...RecruitingColonic Polyps | Colorectal AdenomasChina
-
Genomictree, Inc.Samsung Medical Center; Pusan National University Hospital; Asan Medical Center; Seoul National University Hospital and other collaboratorsRecruitingColorectal Cancer | Advanced Colorectal Neoplasm | Advanced Adenomas | Non-neoplastic Polyps | Non-advanced AdenomasKorea, Republic of
-
PeerMedical Ltd.CompletedColon Cancer | Colon Adenomas | Colon Polyps | Colon DiseasesIsrael
-
Pathway GenomicsCompletedColon Cancer | Colon Adenomas | Colon PolypsUnited States
-
London North West Healthcare NHS TrustCompletedColonic Neoplasms | Colo-rectal Cancer | Colon Adenoma | Adenomas SerratedUnited Kingdom
Clinical Trials on Split dose low-volume PEG solution
-
Kyunghee University Medical CenterHanyang University; Kangbuk Samsung HospitalCompleted
-
Alan BarkunPendopharmCompleted
-
University of CalgaryUnknownColorectal CancerCanada
-
Inje UniversityCompletedColonoscopy | Bowel PreparationKorea, Republic of
-
Air Force Military Medical University, ChinaUnknown
-
Air Force Military Medical University, ChinaCompleted
-
Inje UniversityUnknownColonoscopyKorea, Republic of
-
McGill University Health Centre/Research Institute...Terminated
-
American University of Beirut Medical CenterCompletedBowel Cleansing in Preparation for ColonoscopyLebanon