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

Colonic Adenomas Clinical Trial

Official title:

The Impact of Split Dose of Low-volume Polyethylene Glycol on Adenoma Detection Rate: a Randomized, Investigator Blind, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02178033
• Other study ID #: Split dose-ADR
• Status: Recruiting
• Phase: N/A
• First received: June 25, 2014
• Last updated: June 27, 2014
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: June 2014
• Source: Valduce Hospital
• Contact: Franco Radaelli, MD
• Phone: 0039031324145
• Email: francoradaelli01[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 514
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoma
• Colonic Adenomas

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedale VAlduce, Gastroenterology Unit	Como
Italy	IRCCS Istituto Clinico Humanitas; Gastroenterology Unit	Milano

Sponsors (4)

Lead Sponsor	Collaborator
Valduce Hospital	Istituti Ospitalieri di Cremona, Istituto Clinico Humanitas, Nuovo Regina Margherita Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma Detection Rate	Proportion of patients with at least one adenoma	1 year	No
Secondary	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)	1 year	No
Secondary	Flat/depressed Adenoma Detection Rate	proportion of patients with at least one flat/depressed adenoma	1 year	No
Secondary	Proximal sessile serrated lesion detection rate	Proportion of patients with at least one proximal sessile serrated lesion	1 year	No
Secondary	Number of adenomas per patient	Number of adenomas per patient	1 year	No
Secondary	Number of advanced adenomas per patient	Number of advanced adenomas per patient	1 year	No
Secondary	Number of proximal adenomas	Number of adenomas located in the proximal colon (right and transverse colon)	1 year	No
Secondary	Quality of bowel preparation	Quality of bowel cleansing measured by the Boston Bowel Preparation Scale	1 year	No