Oral sulfate solution versus polyethylene glycol for colonoscopy bowel preparation: a randomized controlled study in phase Ⅲ / 中华消化内镜杂志
Chinese Journal of Digestive Endoscopy
; (12): 261-266, 2022.
Article
em Zh
| WPRIM
| ID: wpr-934102
Biblioteca responsável:
WPRO
ABSTRACT
Objective:
To compare the efficacy of oral sulfate solution (OSS) and polyethylene glycol (PEG) electrolyte powder for colonoscopy bowel preparation.Methods:
A total of 283 randomized patients from 9 centers in China taking OSS ( n=143) or PEG ( n=140) using two-day split bowel preparation regimen received colonoscopy and assessment. The primary index was the bowel preparation success rate [global Boston bowel preparation scale (BBPS)≥ 6 by independent assessment center]. Secondary indices included BBPS global and segmental scores, investigator satisfaction (5-point Likert scale) with the quality of bowel preparation, patient satisfaction assessed by questionnaires, and patient tolerance assessed by Sharma scale. Compliance and safety were compared between the two groups.Results:
The bowel preparation success rates were 100.0% for OSS and 99.3% for PEG [adjusted difference 0.7% (95% CI -5.3% - 6.7%), P<0.001 for non-inferiority]. The BBPS global score in OSS group was significantly higher than that in PEG group (8.1 VS 7.7, P<0.001). The segment BBPS scores were also higher in OSS group than those in PEG group for all 3 segments (right colon 2.4 VS 2.3, P=0.002; transverse colon 2.8 VS 2.7, P=0.018; left colon 2.8 VS 2.7, P=0.007). Investigator Likert score in the OSS group was significantly higher than that in the PEG group (2.6 VS 2.3, P<0.001). There was no significant difference in compliance between OSS and PEG, except for the second dose (90.9% VS 82.6%, P=0.039). There was no significant difference in patient satisfaction, Sharma score or proportion of patients with tolerance-related symptoms between the two groups. Safety was comparable between the two groups, and all adverse events were mild to moderate.Conclusion:
OSS has comparable efficacy with PEG, with higher BBPS scores in all segments, better investigator satisfaction, better compliance in split dose, and comparable patient tolerance and safety.
Texto completo:
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Índice:
WPRIM
Tipo de estudo:
Clinical_trials
Idioma:
Zh
Revista:
Chinese Journal of Digestive Endoscopy
Ano de publicação:
2022
Tipo de documento:
Article