Oral Sulfate Solution Versus Polyethylene Glycol As a Single-Day Preparation for Colonoscopy: a Randomized Control Trial

Published online: 2019-12-12

THIEME .OSSOriginal vs. PEG Article for Colonoscopy Preparation Shah et al 174

Oral Sulfate Solution versus Polyethylene Glycol as a Single-Day Preparation for Colonoscopy: A Randomized Control Trial

Bhavik Bharat Shah1 Bubun Patel1 Mahesh Kumar Goenka1

1Institute of Gastrosciences and Liver, Apollo Gleneagles Hospitals, Address for correspondence Dr. Mahesh Kumar Goenka, Institute of Kolkata, West Bengal, India Gastrosciences and Liver, Apollo Gleneagles Hospitals, Kolkata, West Bengal, India (e-mail: [email protected]).

J Digest Endosc 2019;10:174–177

Abstract Background Colonoscopy is a principal diagnostic tool for most colonic disorders. Adequate bowel preparation is essential for proper visualization of the mucosa. The aim of this study was to compare the tolerability, efficacy, and safety profile of 1 L of oral sulfate solution (OSS) in comparison to 2 L of polyethylene glycol (PEG) solution. Methods In this single-center prospective study conducted at our institute, patients were randomly assigned to receive either OSS or PEG solutions for colonoscopy preparation. Patients enrolled in either group completed a questionnaire assessing the taste of the solution used, adverse effects, and number of stools passed. Grading of the bowel cleansing quality was done as per Boston Bowel Preparation (BBP) score. Results Total of 400 patients, with 222 patients in the PEG group and 178 patients in the OSS group, were assessed. In the PEG group, 148 (66.75%) patients were males and in the OSS group 112 (62.9%) patients were males. There was no statistical signif- icance on comparison of the taste as “good” or “bad” in both groups. All the adverse events were mild to moderate in intensity and their frequencies were comparable for Keywords both the groups. The OSS group had better bowel preparation as per the BBP score ►►colonoscopy (p = 0.021) and lesser cecal intubation time (p = 0.028). preparation Conclusion The present study demonstrated that 1 L of OSS is better than the ►►oral sulfate solution well-established 2 L PEG solution, in terms of bowel preparation and shorter time to ►►polyethylene glycol cecal intubation.

Introduction balance.3-6 The oral sulfate solution (OSS) has been a recently developed formulation which can be administered as a same- Colonoscopy is performed as a principal diagnostic tool in day regimen for bowel preparation. In earlier studies, OSS has most colonic disorders. Adequate bowel preparation is essen- shown not to alter the serum electrolyte balance and also tial for proper visualization of the colonic mucosa. Superior urine from study subjects did not commonly form a calcium cleansing minimizes the risk of missing lesions, need for precipitate.7,8 Unlike sodium phosphate, high doses of OSS repeat procedure and associated increase in cost of colo- administered to rats and dogs showed no evidence of soft noscopy, improves cecal intubation, and decreases patient’s tissue or kidney calcification.9 However, the major benefit of 1,2 discomfort. OSS is that only 1 L of solution has to be consumed, as com- Per oral polyethylene glycol (PEG) solution has been the pared with 2 L of PEG solution. This may increase patient’s most commonly used cleansing agent in recent years. This comfort. The purpose of this study was to compare the tol- is a nondigestible, nonabsorbable, osmotically balanced lax- erability, efficacy, and safety profile of OSS in comparison to ative lavage solution, that does not alter fluid and electrolyte PEG solution.

Patients and Methods and in the OSS group was 43.89 (± 13.67) years (p = 0.91). ►Table 1 shows various indications for which colonoscopy This was a randomized, double-blinded, single-center study was performed in both the groups. Clinically suspected conducted at our institute from July 2018 to February 2019. irritable bowel syndrome and constipation were the most Patients aged more than 18 years, from the outpatient and common indication in both the groups. When the taste sen- inpatients department, who were scheduled to undergo sation was compared on the basis of questionnaire, “good colonoscopy were enrolled. A written informed consent was taste” was observed in 134 (60.4%) patients in the PEG group obtained from each patient. Patients with > 50% colon resec- and 101 (56.7%) patients in the OSS group. The comparison tion, severe constipation (< 1 bowel movement per week), between the two groups was not statistically significant known or suspected gastroparesis, severe nausea or vomit- (p = 0.57). Similarly, the rest of the patients observed “bad ing, bowel obstruction, cardiac and renal failure, pregnancy, taste” which was also not statistically significant (p = 0.57) and lactation were excluded. The eligible patients were ran- between the two groups. The colonoscopy findings were domly assigned by the envelope method to OSS and PEG comparable in the PEG and OSS groups (►Table 2). groups by endoscopy room staff not involved in the colonos- In both the groups, the most common complaint after copy procedure. consumption of PEG and OSS was nausea, vomiting, and All study procedures were performed by trained gastroen- abdominal bloating. The frequencies of reported adverse terologists. Patients in the PEG group were asked to consume events, including nausea, vomiting, abdominal pain, abdomi- 137.15 g of commercially available PEG powder with electro- nal bloating, headache, fatigue, and reeling to the head, were lytes in 2 L of water to prepare a solution. In the OSS group, comparable in both the groups (►Table 3). All the adverse 117 mL of OSS was mixed with cold or normal water as events were mild to moderate in intensity. No serious adverse required to make a total solution of 500 mL. Two such bottles events occurred in both the groups. were given to the patient, each of which had to be consumed Complete examination of the colon was possible in 390 over 10 to 20 minutes, keeping a gap of 1 hour in between (97.5%) patients. Ten patients required repeat prepara- the two. Preparations in both the groups were initiated 6 to tion. There was no difference in the two groups for the 8 hours before the colonoscopy. requirement of repeat preparation (2.7% vs. 2.2%, p = 0.88). All the enrolled patients completed a questionnaire assess- For assessment of cleanliness, quality was assessed in 390 ing the taste of the solution, adverse effects, and number of patients in whom complete colonoscopy could be achieved. stools passed for either group. Adverse effects, like nausea, The significant difference (p = 0.021) was seen favoring the

vomiting, abdominal pain, headache, fatigability, and others, OSS group in bowel cleansing as per the BBP score (►Table 4). were scored on a 5-point scale, where 1 = “none”; 2 = “mild”; The time required for cecal intubation was 5.23 ± 3.35 min- 3 = “bothersome”; 4 = “distressing”; and 5 = “severely dis- utes in the OSS group as compared with 6.05 ± 4.1 minutes tressing.” This scale has been used in earlier bowel cleansing in the PEG group, which was significantly less (p = 0.028). 7 studies. Total time taken to complete the procedure, cecal We also found that as the number of stools passed after intubation and extubation time, was noted by the endosco- consumption of either preparation were higher than 6, BBP pist performing the procedure. Grading of the preparation score also improved (p = 0.001). quality was done as per the Boston Bowel Preparation (BBP) score, which has excellent interobserver reliability, and is proven to be related to the endoscopy outcome.10,11 Total BBP Table 1 Indications of colonoscopy in the two groups score3 of 6 was taken as adequate preparation and score of < 6 Indication PEG (n = 222) OSS (n = 178) was considered inadequate p