P233 Efficacy and safety of oral sulfate tablet for the bowel preparation in patients with inflammatory bowel disease: multicenter randomized controlled study
Kim, K.O.(1);Jang, B.I.(1);Lee, Y.J.(2);Lee, H.S.(3);Kim, E.S.(3);Jung, Y.J.(4);Kim, E.Y.(5);Kim, S.K.(3);Yang, C.H.(1);
(1)Yeungnam University College of Medicine, Division of Gastroenterology and Hepatology- Department of Internal Medicine, Daegu, Korea- Republic Of;(2)Keimyung University School of Medicine, Division of Gastroenterology and Hepatology- Department of Internal Medicine, Daegu, Korea- Republic Of;(3)Kyungpook National University School of Medicine, Division of Gastroenteorlogy and Hepatology- Department of Internal Medicine, Daegu, Korea- Republic Of;(4)Fatima Hospital of Daegu, Division of Gastroenterology and Hepatology- Department of Internal Medicine, Daegu, Korea- Republic Of;(5)Daegu Catholic University School of Medicine, Division of Gastroenterology and Hepatology- Department of Internal Medicine, Daegu, Korea- Republic Of; Crohn's and Colitis Association in Daegu-Gyeongbuk (CCAiD)
Background
Although high and low volume polyethylene glycol(PEG) bowel preparations are recommended for patients with inflammatory bowel disease(IBD) before colonoscopy, sometime it is limited due to poor compliance. So, studies regarding novel low volume preparations in IBD are need, but, there is limited data. We aimed to evaluated the safety, tolerability and efficacy of oral sulfate tablet (OST) by comparison with 2L PEG and ascorbate (PEG/Asc) in patients with IBD.
Methods
One hundred ten patients with IBD were enrolled in this single-blind, multicenter, non-inferiority study. Patients were assigned either 2L PEG/Asc or OST to be administered in a split-dose regimen. OST patients were administered 14 tablets with more than 1L of free water in the evening, and the following morning. Colonoscopies were performed by blinded investigators. The primary efficacy endpoint was successful bowel cleansing rate, defined as Harefield Cleansing Scale grade A or B as evaluated by blinded endoscopist in each hospital. Secondary endpoints included the presence of residual air bubbles. Adverse events and laboratory evaluations were monitored to assess safety. Flare up of IBD symptoms and mucosa change associated with preparation were also evaluated. Tolerability, in terms of taste and degree of resistance to drink was assessed with VAS score by interview before colnoscopy. Safety was assessed by spontaneously reported adverse events, solicited ratings of expected prep symptoms, and laboratory testing.
Results
The cleansing score at all the segment was significantly higher in OST group. A high rate of cleansing success was seen with OST (98.1%), which was noninferior to 2L PEG/Asc (98.1%). Proportion of patients with bubble score 0 was significantly higher in OST than 2L PEPG/Asc group (94.5% vs. 50.0%, p<0.001). Satisfaction, in terms of easiness to drink (8.2 ± 1.6 vs. 6.0 ± 2.2, p<0.001) and taste(7.0 ± 2.8 vs. 5.4 ± 2.4, p=0.002) was significantly higher in OST group. More patients in OST group (94.5%) wanted to repeat the same preparation next colonoscopy. There was no significant difference in the development of vomiting and bloating between group. Aphthous ulcers were noted in the same number of patients in both group and symptom flare up were noted in 2 cases of OST group (p=1.000). No clinically significant differences were seen between preps for renal function and serum electrolyte.
Conclusion
Oral sulfate tablets achieved a high level of cleansing comparable with 2L PEG/Asc in patients with IBD. The risk of mucosal change or symptom relapse were not higher, on the other hand the degree of satisfaction was higher than 2L PEG/Asc. OST split method could be considered as one of the preparation method for patients with inactive IBD.