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The Impact of Split Dose of Low-volume Polyethylene Glycol on Adenoma Detection Rate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02178033
Recruitment Status : Unknown
Verified June 2014 by Franco Radaelli, Valduce Hospital.
Recruitment status was:  Recruiting
First Posted : June 30, 2014
Last Update Posted : June 30, 2014
Sponsor:
Collaborators:
Istituto Clinico Humanitas
Istituti Ospitalieri di Cremona
Nuovo Regina Margherita Hospital
Information provided by (Responsible Party):
Franco Radaelli, Valduce Hospital

Brief 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 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).


Condition or disease Intervention/treatment Phase
Colonic Adenomas Drug: Split dose low-volume PEG solution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 514 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: The Impact of Split Dose of Low-volume Polyethylene Glycol on Adenoma Detection Rate: a Randomized, Investigator Blind, Controlled Trial
Study Start Date : January 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: MoviPrep

Arm Intervention/treatment
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.
Drug: Split dose low-volume PEG solution
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 Name: Low-volumePEG solution used in this study: MOVIPREP®, Norgine, Harefield, United Kingdom

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.
Drug: Split dose low-volume PEG solution
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 Name: Low-volumePEG solution used in this study: MOVIPREP®, Norgine, Harefield, United Kingdom




Primary Outcome Measures :
  1. Adenoma Detection Rate [ Time Frame: 1 year ]
    Proportion of patients with at least one adenoma


Secondary Outcome Measures :
  1. 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)

  2. Flat/depressed Adenoma Detection Rate [ Time Frame: 1 year ]
    proportion of patients with at least one flat/depressed adenoma

  3. Proximal sessile serrated lesion detection rate [ Time Frame: 1 year ]
    Proportion of patients with at least one proximal sessile serrated lesion

  4. Number of adenomas per patient [ Time Frame: 1 year ]
    Number of adenomas per patient

  5. Number of advanced adenomas per patient [ Time Frame: 1 year ]
    Number of advanced adenomas per patient

  6. Number of proximal adenomas [ Time Frame: 1 year ]
    Number of adenomas located in the proximal colon (right and transverse colon)

  7. Quality of bowel preparation [ Time Frame: 1 year ]
    Quality of bowel cleansing measured by the Boston Bowel Preparation Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178033


Contacts
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Contact: Franco Radaelli, MD 0039031324145 francoradaelli01@gmail.com

Locations
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Italy
Ospedale VAlduce, Gastroenterology Unit Recruiting
Como, Italy, 22100
Contact: Franco Radaelli, MD    0039031324145      
IRCCS Istituto Clinico Humanitas; Gastroenterology Unit Recruiting
Milano, Italy, 20100
Contact: Alessandro Repici, MD    00390282241    alessandro.repici@humanitas.it   
Sponsors and Collaborators
Valduce Hospital
Istituto Clinico Humanitas
Istituti Ospitalieri di Cremona
Nuovo Regina Margherita Hospital
Investigators
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Principal Investigator: Franco Radaelli, MD Ospedale Valduce, Gastroenterology Unit, Via Dante 10, 22100, Como, Italy.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Franco Radaelli, MD, Valduce Hospital
ClinicalTrials.gov Identifier: NCT02178033    
Other Study ID Numbers: Split dose-ADR
First Posted: June 30, 2014    Key Record Dates
Last Update Posted: June 30, 2014
Last Verified: June 2014
Keywords provided by Franco Radaelli, Valduce Hospital:
adenoma detection rate, screening colonoscopy
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharmaceutical Solutions