Rapid Colonoscopy Preparation Using Bolus Lukewarm Saline Combined with Sequential Posture Changes: A Randomized Controlled Trial

In this randomized clinical trial, we have compared the Shudh (TM) colon cleanse (SCC) with HalfLytely(A (R)) colon prep (HCP) to evaluate the efficacy, bowel preparation time (BPT), adverse events, electrolyte abnormalities and patient acceptability. Patients were randomized to receive either SCC (n = 65) or HCP (n = 68). All colonoscopies were performed by a single, blinded endoscopist. Colon prep was evaluated on a 5 point grading scale. Statistical non-inferiority was pre-defined as a difference of < 15 % in the lower limit of the 95.5 % confidence interval for the treatment difference. Data that were collected include bowel prep score, BPT, adverse events, electrolyte abnormalities and patient acceptability. Bowel preparation efficacy was rated as "successful" for 59/65 (90.7 %) in SCC versus 66/68 (97.1 %) in HCP. This gave a success difference of -6.4 % with a 1-sided 95 % lower confidence limit (LCI) for the difference = -13.3 % (non-inferiority p = 0.25). This difference fell within the predefined limit for non-inferiority. The average BPT for SCC was 1.9 h versus 10.9 in HCP (p < 0.001). No serious adverse events were reported in either group. None of the patients in either group had any clinically significant electrolyte imbalance. Patient ratings for palatability and willingness to repeat were significantly better for SCC (p < 0.05). SCC was found to not be inferior to PEG with regards to the quality of bowel preparation. It is worth highlighting that a major advantage of SCC is shorter BPT. (Clinical trial registration number: NCT01547130).