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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

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 questi
Sponsor: Valduce Hospital

Current Primary Outcome: Adenoma Detection Rate [ Time Frame: 1 year ]

Proportion of patients with at least one adenoma


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)
  • Flat/depressed Adenoma Detection Rate [ Time Frame: 1 year ]
    proportion of patients with at least one flat/depressed adenoma
  • Proximal sessile serrated lesion detection rate [ Time Frame: 1 year ]
    Proportion of patients with at least one proximal sessile serrated lesion
  • Number of adenomas per patient [ Time Frame: 1 year ]
    Number of adenomas per patient
  • Number of advanced adenomas per patient [ Time Frame: 1 year ]
    Number of advanced adenomas per patient
  • Number of proximal adenomas [ Time Frame: 1 year ]
    Number of adenomas located in the proximal colon (right and transverse colon)
  • Quality of bowel preparation [ Time Frame: 1 year ]
    Quality of bowel cleansing measured by the Boston Bowel Preparation Scale


Original Secondary Outcome: Same as current

Information By: Valduce Hospital

Dates:
Date Received: June 25, 2014
Date Started: January 2014
Date Completion: January 2015
Last Updated: June 27, 2014
Last Verified: June 2014