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

Abstract

ObjectiveIn this randomized clinical trial, we have compared the Shudh™ colon cleanse (SCC) with HalfLytely® colon prep (HCP) to evaluate the efficacy, bowel preparation time (BPT), adverse events, electrolyte abnormalities and patient acceptability.MethodsPatients 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.ResultsBowel 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).ConclusionSCC 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).Electronic supplementary materialThe online version of this article (doi:10.1007/s10620-013-2598-9) contains supplementary material, which is available to authorized users.

Meditations on Bowel Preps

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The randomized, controlled trial presented by Arya et al [1] in this issue of the journal evaluates a novel approach to bowel preparation involving the ingestion of large volumes of lukewarm saline combined with a regimen of relaxation, meditation, yogic postural changes, and breathing exercises (the Shudh model), versus ingesting 2L of a PEG-based solution with bisacodyl. The Shudh model challenges existing approaches to bowel cleansing, in that it is not primarily based on the use of a laxative preparation but rather endeavours to use a number of strategies intended to trigger parasympathetic activation to encourage bowel emptying.

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“…Data collected for a recent meta-analysis would suggest that success rates of 70-90 % are more likely to be achieved for a regimen using low volume PEG with bisacodyl [4]. One must therefore call into question whether the cleansing assessment tool used was sufficiently discriminatory to detect truly adequate bowel preparation in this study.The tool used for the evaluation involved the rating of six anatomical segments of the colon (rectum, sigmoid, -013-2760-4 descending colon, transverse colon, ascending colon and cecum) on the 5-point Arya bowel prep scale [1]. Success in this study (grade A or B) was based on achieving a score of [12 out of a possible range of 0-24.…”

“…The tool used for the evaluation involved the rating of six anatomical segments of the colon (rectum, sigmoid, -013-2760-4 descending colon, transverse colon, ascending colon and cecum) on the 5-point Arya bowel prep scale [1]. Success in this study (grade A or B) was based on achieving a score of [12 out of a possible range of 0-24.…”

“…In the study by Arya et al [1] a single endoscopist, blinded to the bowel preparation allocation, assessed cleansing in 133 patients undergoing colonoscopy (42 % for screening and 58 % for diagnostic purposes) using a segmental assessment scale developed by themselves for this study. Based on this scale, they demonstrated that successful cleansing (as defined below) was achieved in 97 % of patients using 2L PEG with bisacodyl and 91 % of those using the Shudh approach-a difference that was consistent with non-inferiority for Shudh.…”

“…In this study, a specially trained nurse briefed the patients, who were then given a DVD demonstrating the techniques [1]. Clearly, this is somewhat more complex than the instruction required for conventional bowel preparation regimens, which themselves suffer from problems of incomplete adherence.…”