Gut Liver.  2019 Mar;13(2):176-182. 10.5009/gnl18214.

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

• Kwak MS
• Cha JM
• Yang HJ
• Park DI
• Kim KO
• Lee J
• Shin JE
• Joo YE
• Park J
• Byeon JS
• Kim HG
• Intestinal Cancer Study Group of the Korean Association for the Study of Intestinal Diseases (KASID)

• KMID: 2446802
• DOI: http://doi.org/10.5009/gnl18214

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)

Keyword

Colonoscopy; Cathartics; Safety; Treatment outcome; Aged

MeSH Terms

Acute Kidney Injury
Aged*
Cathartics
Colon
Colonoscopy
Detergents
Humans
Polyethylene Glycols
Treatment Outcome
Cathartics
Detergents
Polyethylene Glycols