Stanislas Chaussade1, Christoph Schmöcker2, Pierre Toulemonde3, Miguel Muñoz-Navas4, Valérie O'Mahony5, Franck Henri5. 1. Gastroenterology and Endoscopy Unit, Faculté de Médecine, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris Descartes, Sorbonne Paris Cité, Pavillon Achard, 27 rue du faubourg St Jacques, 75014, Paris, France. stanislas.chaussade@aphp.fr. 2. Sana Klinikum Lichtenberg, Berlin, Germany. 3. Clinique Saint-Jean Languedoc, 20 route de Revel, Toulouse, France. 4. Clinica Universidad de Navarra, Pamplona, Spain. 5. Département médical, Laboratoires Mayoly Spindler, Chatou, France.
Abstract
BACKGROUND: Adequate bowel preparation is a crucial step in colonoscopy procedure and has been identified as the cornerstone of a quality colonoscopy. Polyethylene glycol (PEG) for bowel cleansing still had up to 10 % unprepared colon. AIM: We herein compare efficacy, acceptability, tolerance and safety of sodium phosphate (NaP) tablets and split-dose PEG for bowel cleansing. PATIENTS AND METHODS: A prospective non-inferiority randomized trial was performed and registered on www.clinicaltrials.gov (NCT01840553). Patients were randomized to either 32 NaP tablets or 4 L of PEG. Blind readers assessed the efficacy of colon cleansing using the Boston Bowel Preparation Scale (BBPS). RESULTS: A total of 461 patients were randomized in groups (NaP group: n = 231; PEG group: n = 230). Median age was 54 and 52 in NaP group and PEG group, respectively (p < 0.01). Patients experienced an overall compliance to the treatment in 99.6 and 94.1 % in the NaP group and in the PEG group, respectively (p < 0.001). The mean time of withdrawal was 15.1 ± 8.9 and 15.4 ± 9.5 min in the NaP group and in the PEG group, respectively (p = 0.95). The good quality of bowel preparation, defined as BBPS score ≥7, was obtained in 86.4 and 89.0 % of cases in the NaP group and in the PEG group, respectively (p = 0.42). In all segment (right colon, transverse colon and left colon and rectum), the NaP group was non-inferior to the PEG group. Bowel prep regimen was more frequently considered as "easy" by patients from the NaP group (54.8 % of patients) than patients from the PEG group (29.0 % of patients; p < 0.001). No serious adverse events were reported. No statistical differences were found between the NaP group and the PEG group concerning the incidence of an adverse event (338 vs. 322, respectively). CONCLUSION: While NaP tablets appeared as efficient as PEG in terms of colon cleansing prior to a colonoscopy, they significantly improved the overall compliance and eased product administration. At an era where bowel cleansing appears to be the cornerstone of a quality colonoscopy, NaP tablets in patients without contraindication might be considered as an option.
RCT Entities:
BACKGROUND: Adequate bowel preparation is a crucial step in colonoscopy procedure and has been identified as the cornerstone of a quality colonoscopy. Polyethylene glycol (PEG) for bowel cleansing still had up to 10 % unprepared colon. AIM: We herein compare efficacy, acceptability, tolerance and safety of sodium phosphate (NaP) tablets and split-dose PEG for bowel cleansing. PATIENTS AND METHODS: A prospective non-inferiority randomized trial was performed and registered on www.clinicaltrials.gov (NCT01840553). Patients were randomized to either 32 NaP tablets or 4 L of PEG. Blind readers assessed the efficacy of colon cleansing using the Boston Bowel Preparation Scale (BBPS). RESULTS: A total of 461 patients were randomized in groups (NaP group: n = 231; PEG group: n = 230). Median age was 54 and 52 in NaP group and PEG group, respectively (p < 0.01). Patients experienced an overall compliance to the treatment in 99.6 and 94.1 % in the NaP group and in the PEG group, respectively (p < 0.001). The mean time of withdrawal was 15.1 ± 8.9 and 15.4 ± 9.5 min in the NaP group and in the PEG group, respectively (p = 0.95). The good quality of bowel preparation, defined as BBPS score ≥7, was obtained in 86.4 and 89.0 % of cases in the NaP group and in the PEG group, respectively (p = 0.42). In all segment (right colon, transverse colon and left colon and rectum), the NaP group was non-inferior to the PEG group. Bowel prep regimen was more frequently considered as "easy" by patients from the NaP group (54.8 % of patients) than patients from the PEG group (29.0 % of patients; p < 0.001). No serious adverse events were reported. No statistical differences were found between the NaP group and the PEG group concerning the incidence of an adverse event (338 vs. 322, respectively). CONCLUSION: While NaP tablets appeared as efficient as PEG in terms of colon cleansing prior to a colonoscopy, they significantly improved the overall compliance and eased product administration. At an era where bowel cleansing appears to be the cornerstone of a quality colonoscopy, NaP tablets in patients without contraindication might be considered as an option.
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