A Multicenter Randomized Phase 4 Trial Comparing Sodium Picosulphate Plus Magnesium Citrate vs Polyethylene Glycol Plus Ascorbic Acid for Bowel PREparation Before COLonoscopy. The PRECOL Trial

Abstract

Background: Adequate bowel preparation before colonoscopy is crucial. Unfortunately, up to 25% of all colonoscopies have inadequate bowel cleansing. From a patient perspective, bowel preparation is a main obstacle for colonoscopy. Several low-volume bowel preparations have been formulated to provide more tolerable purgative solutions without loss of efficacy.

Methods: In this phase 4, randomized, multicenter, two-arm trial, adult outpatients undergoing colonoscopy received either Sodium Picosulphate plus Magnesium Citrate (SPMC) or Polyethylene Glycol plus Ascorbic Acid (PEG-ASC) for bowel preparation. The primary aims were to test quality of bowel cleansing (primary endpoint, scored according the Boston Bowel Preparation Scale) and patient’s acceptance (measured with 6 visual analogue scales). The study was open as for treatment assignment, and blinded for primary endpoint assessment that was done independently on videotaped colonoscopies by 2 endoscopists not aware of study arm. A sample size of 525 patients was calculated to recognize a difference of 10% in the proportion of successes between the arms with a two-sided alpha error of 0·05 and 90% statistical power.

Findings: overall 550 subjects (279 assigned to PEG-ASC and 271 assigned to SPMC) represented the analysis population. There was no statistically significant difference in the success rate according to BBPS: 94·4% with PEG-ASC and 95·7% with SPMC (P=0·49). Acceptance and willing to repeat were significantly better for SPMC with all the scales. Compliance was less than full in 6·6% and 9·9% of cases with PEG-ASC and SPMC, respectively (P=0·17). Nausea and meteorism were significantly more bothersome with PEG-ASC than SPMC. There were no serious adverse events in either group.

Interpretation. SPMC and PEG-ASC are not different in terms of efficacy, but SPMC is better tolerated than PEG-ASC. SPMC could be used as alternative to low-volume PEG based purgative solutions for bowel preparation.

Trial Registration: The trial was registered at ClinicalTrials.gov (NCT01649674) and EudraCT (2011—000587—10).

Funding Statement: This research had no financial support.

Declaration of Interests: Valentina D'Angelo, Ciro Gallo, Elena Di Girolamo, Pietro Marone, Giovanni Battista Rossi, Corrado Civiletti, Marco Romano, Agnese Miranda, Domenico Taranto, Gabriella Sessa, Pasquale Esposito, Raffaele Salerno, Rossella Pumpo, Francesca Romana De Filippo, Elisabetta Della Valle and Mario de Bellis have nothing to disclose regarding financial and personal relationships with other people or organisations, even if it does not directly relate to the submitted work.

Dr. Di Maio reports personal fees from Merck Sharp & Dohme, personal fees from Bristol Myers Squibb, personal fees from Eisai, personal fees from Janssen, personal fees from Astellas, personal fees from AstraZeneca, personal fees from Pfizer, grants from Tesaro, outside the submitted work.

Dr. Perrone reports grants, personal fees and non-financial support from Bayer, personal fees from Sandoz, grants and personal fees from Incyte, personal fees from Celgene, grants and personal fees from Astra Zeneca, personal fees from Pierre Fabre, personal fees from Janssen Cilag, grants from Roche, grants from Pfizer, outside the submitted work.

Dr. Piccirillo reports personal fees from Daiichi Sankyo, personal fees from Glaxo, non-financial support from Bayer, personal fees from Astra Zeneca, grants from Astra Zeneca, personal fees from MSD, outside the submitted work.

Ethics Approval Statement: The study protocol was approved by the Ethics Committees of the 7 participating sites. The study was conducted in accordance with the Declaration of Helsinki Principles, Good Clinical Practice, and applicable regulatory requirements. All participants provided written informed consent.