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

Vijaypal Arya 0 1 2 3 4 5 6 7 8 9 10 11 Kalpana A. Gupta 0 1 2 3 4 5 6 7 8 9 10 11 Ashok Valluri 0 1 2 3 4 5 6 7 8 9 10 11 Swarn V. Arya 0 1 2 3 4 5 6 7 8 9 10 11 Martin L. Lesser 0 1 2 3 4 5 6 7 8 9 10 11 0 M. L. Lesser Department of Population Health, Hofstra North Shore-LIJ School of Medicine , New Hyde Park, NY, USA 1 V. Arya Weill Medical College of Cornell University , Newyork, NY, USA 2 M. L. Lesser Department of Molecular Medicine, Hofstra North Shore-LIJ School of Medicine , New Hyde Park, NY, USA 3 V. Arya (&) 75-54 Metropolitan Ave, Midldle Village, NY 11379, USA 4 Presented at: ACG 2009Presidential Poster Award Recipient, San Diego, CA . ACG 2010, San Antonio, TX 5 M. L. Lesser Biostatistics Unit, Feinstein Institute for Medical Research , Manhasset, NY, USA 6 S. V. Arya Cornell University , Ithaca, NY, USA 7 A. Valluri Wyckoff Heights Medical Center , Brooklyn, NY, USA 8 K. A. Gupta Methodist Hospital , Brooklyn, NY, USA 9 V. Arya North Shore University Hospital , Manhasset, NY, USA 10 V. Arya Brooklyn Hospital , Brooklyn, NY, USA 11 V. Arya Division of Gastroenterology/Hepatobiliary Diseases, Wyckoff Heights Medical Center , Brooklyn, NY, USA Objective In this randomized clinical trial, we have compared the ShudhTM colon cleanse (SCC) with HalfLytely colon prep (HCP) to evaluate the efficacy, bowel preparation time (BPT), adverse events, electrolyte abnormalities and patient acceptability. Methods 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 predefined 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. Results 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). Conclusion 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). Colon preparation Saline Posture Colon cancer is the third most common cancer in the United States and is the second leading cause of cancer deaths [1]. Importantly, colon neoplasm is one of the most preventable cancers, and regular colonoscopy screening could prevent most deaths due to this cancer by early detection and removal of both cancer and precancerous polyps [2]. Despite this evidence, screening rates are disturbingly low. Nationally, only about 35 % of Americans aged 50 years and older have ever undergone colonoscopy [3]. From a patient perspective, several factors influence this low rate of screening, including low household income, lack of health insurance, being of Hispanic or Asian decent, limited access to care, and no physician recommendation to be screened [4]. A quality colonoscopy examination remains as the gold standard for colorectal cancer screening [5, 6]. Although it is a valuable diagnostic tool, many eligible patients are intimidated by the idea of a colonoscopy. For those patients who are able and willing to undergo the colonoscopy procedure, colon cleansing is a major barrier to meticulous mucosal examination from rectum to cecum [7, 8]. Polyethylene glycol (PEG) based preps have been used as the major bowel preparation for colonoscopy in the United States. However, the total volume of intake, prep duration, and palatability continue to be major patient concerns. These factors influence patient acceptability and subsequently the preparation outcome [9, 10]. An ideal colon prep should be safe, effective, fast, palatable and economical. Additionally, it should have minimal dietary restrictions and should not interrupt sleep. To date, no single prep has been consistently superior for all groups of patients [11]. The search for an ideal prep continues. The use of complementary and alternative medicine in the United States is on the rise [12, 13] The beneficial effects of alternative therapies on cardiovascular, neuroendocrine, and other systems have been reported [1419]. Thus we endeavored to apply the principles of mindful meditation in order to ascertain its effects in colonoscopy preparation. Bolus drinking of lukewarm saline with sequential posture changes is an alternative process that has been used for internal cleansing. We standardized this process as ShudhTM (suggested pronunciation should) and compared with NuLytely [20]. In addition to mindfulness, there are two active components in SCC: A-Bolus (8 oz/240 mL in 12 min) drinking of lukewarm normal saline and B-sequential posture changes (SPC) of mild intensity (metabolic equivalent value of three [21]) with deep breathing. Although it appears to be simplistic, the innovative aspect of SCC focuses on a bolus intake of saline solution in quick succession (every 45 min) rather than intermittent sipping (Fig. 1). It is theorized that a bolus intake versus intermittent sipping should lead to a larger amount of gastric emptying (first order kineticswith a time to 50 % emptying of 818 min for isotonic, non-nutritive liquids [2224]).When two meals are taken within a few minutes, the gastric emptying of the second meal is faster than that of the first [22, 25]. The saline load is known to stimulate the gastro-colic reflex [26]. Simultaneously, the resultant high flow rate of isotonic solution in the intestine should allow minimal time for ionic exchange, leading to less absorption. We propose a model that explains the plausible mechanism of action (Fig. 2). Inputs from sensory sources are modified by cognition and effect, and then integrated in the central nervous system (CNS), autonomic nervous system (ANS) and enteric nervous system (ENS) with an outcome of effects on gastro-intestinal (GI) motility, secretion and blood flow [27]. In SCC, thinking to get clean (mindfulness), deep breathing (pulmonary stretch reflex) [28], bolus drinking [2325] of isotonic lukewarm saline [29, 30], and SPC (mild intensity exercise [31], gravity and posture [32 34]) activate the CNS, parasympathetic component of ANS, and ENS. This leads to gastric receptive relaxation, gastro-colic reflex and increased GI motility. A detailed description of these mechanisms is beyond the sco (...truncated)