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

NCT02178033 | Unknown

• 1 other identifier: Split dose-ADR
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 2

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).

Conditions

Colonic Adenomas

Keywords

adenoma detection rate, screening colonoscopy

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate

  Proportion of patients with at least one adenoma

  1 year

Secondary Outcomes (7)

• Advanced Adenoma Detection Rate

  1 year

• Flat/depressed Adenoma Detection Rate

  1 year

• Proximal sessile serrated lesion detection rate

  1 year

• Number of adenomas per patient

  1 year

• Number of advanced adenomas per patient

  1 year

Study Arms (2)

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.

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.

Drug: Split dose low-volume PEG solution

Interventions

Split dose low-volume PEG solution DRUG

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.

Also known as: Low-volumePEG solution used in this study: MOVIPREP®, Norgine, Harefield, United Kingdom

Split dose low-volume PEG solution; low-volume (2L) PEG

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• asymptomatic subjects aged 50-69 participating to regional screening program and undergoing outpatient colonoscopy for positive immunologic fecal occult blood test.

You may not qualify if:

• 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

Sponsors & Collaborators

• Valduce Hospital: lead
• Istituto Clinico Humanitas: collaborator
• Istituti Ospitalieri di Cremona: collaborator
• Nuovo Regina Margherita Hospital: collaborator

Study Sites (2)

Ospedale VAlduce, Gastroenterology Unit

Como, 22100, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas; Gastroenterology Unit

Milan, 20100, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 26657900 DERIVED

Study Officials

• Franco Radaelli, MD

  Ospedale Valduce, Gastroenterology Unit, Via Dante 10, 22100, Como, Italy.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franco Radaelli, MD

CONTACT

0039031324145; francoradaelli01@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 30, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: June 30, 2014

Record last verified: 2014-06

Locations

IT (2)