Safety and Efficacy of Low-Volume Preparation in the Elderly: Oral Sulfate Solution on the Day before and Split-Dose Regimens (SEE SAFE) Study
Gut and Liver
; : 176-182, 2019.
Article
in En
| WPRIM
| ID: wpr-763831
Responsible library:
WPRO
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)Key words
Full text:
1
Database:
WPRIM
Main subject:
Polyethylene Glycols
/
Cathartics
/
Colonoscopy
/
Treatment Outcome
/
Colon
/
Detergents
/
Acute Kidney Injury
Type of study:
Clinical_trials
/
Prognostic_studies
Limits:
Aged
/
Humans
Language:
En
Journal:
Gut and Liver
Year:
2019
Document type:
Article