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.
Creators
- D'Angelo Valentina1
- Piccirillo Maria Carmela2
- Di Maio Massimo3
- Gallo Ciro4
- Di Girolamo Elena1
- Marone Pietro1
- Rossi Giovanni Battista1
- Civiletti Corrado1
- Romano Marco5
- Miranda Agnese5
- Taranto Domenico6
- Sessa Gabriella6
- Esposito Pasquale5
- Salerno Raffaele7
- Pumpo Rossella8
- De Filippo Francesca Romana9
- Della Valle Elisabetta10
- de Bellis Mario1
- Perrone Francesco2
- 1. Division of Gastroenterology and Digestive Endoscopy, Department of Abdominal Oncology, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale, Napoli, Italy
- 2. Clinical Trial Unit, Department of Translational Research, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale, Napoli, Italy
- 3. Department of Oncology, University of Torino, Ospedale Mauriziano, Torino, Italy
- 4. Medical Statistics Unit, University of Campania Luigi Vanvitelli, Napoli, Italy
- 5. Division of Gastroenterology, University of Campania Luigi Vanvitelli, Napoli, Italy
- 6. Division of Gastroenterology, Clinica Mediterranea, Napoli, Italy
- 7. Division of Gastroenterology, ASST Fatebenefratelli Sacco, Milano, Italy
- 8. Digestive Endoscopy Unit, Ospedale S. Maria del Loreto Nuovo, Napoli, Italy
- 9. Division of Gastroenterology, Ospedale Ruggi D'Aragona, Salerno, Italy
- 10. Department of Public Health, University of Campania Federico II, Napoli, Italy
Description
This is the database for final analysis of the PRECOL clinical trial, whose abstract follows
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.
Funding. This research had no financial support.
ClinicalTrials.gov NCT01649674; EudraCT 2011—000587—10.
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