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Safety and Efficacy of Low-Volume Preparation in the Elderly: Oral Sulfate Solution on the Day before and Split-Dose Regimens (SEE SAFE) Study.

Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea. Department of Internal Medicine, Sungkyunkwan University College of Medicine, Suwon, Korea. Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea. Department of Internal Medicine, Chosun University College of Medicine, Gwangju, Korea. Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea. Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea. Department of Internal Medicine, Inje University College of Medicine, Gwangju, Korea. Department of Internal Medicine, University of Ulsan College of Medicine, Korea, Gwangju, Korea. Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.

Gut and liver. 2019;(2):176-182
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Abstract

BACKGROUND/AIMS: The use of a low-volume bowel cleansing agent is associated with a greater willingness to undergo repeat colonoscopy. Oral sulfate solution (OSS) is a recently approved low-volume agent; however, its efficacy and safety in the elderly population remain unclear. We aimed to evaluate the efficacy, safety, and acceptability of the OSS preparation, in comparison to those of a standard polyethylene glycol (PEG; 4 L) preparation, in elderly patients. METHODS A multicenter, randomized, investigator-blinded study was conducted. Participants were randomized to receive OSS or 4-L PEG with a split-dose regimen. Bowel cleansing efficacy was assessed using the Boston Bowel Preparation Scale (BBPS). Acceptance, satisfaction, and preparation-related symptoms were recorded. Additionally, blood parameters were analyzed for electrolyte abnormalities and nephrotoxicity. RESULTS A total of 193 patients were analyzed. No group differences in overall bowel cleansing efficacy were observed, with "adequate"preparations achieved in 95.9% (93/97) and 94.8% (91/96) of patients in the OSS and 4L PEG groups, respectively (p=0.747). However, mean BBPS scores for the entire (p=0.010) and right colon (p=0.001) were significantly higher in the OSS group than in the 4-L PEG group. The severity of clinical adverse events and frequency of acute kidney injury were similarly low, and no clinically meaningful electrolyte changes were identified. Self-reported scores regarding amount (p<0.001) and feeling (p=0.007), as well as overall satisfaction (p=0.001) and willingness to repeat the preparation (92.8% vs 67.7%, p<0.001), were significantly better in the OSS group than in the 4-L PEG group. CONCLUSIONS In elderly individuals, OSS with a split-dose regimen has greater acceptability and comparable efficacy in bowel cleansing compared to 4-L PEG. (Clinical trials registration number: NCT03112967).

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