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Background/Aims: The use of 1-L polyethylene glycol with ascorbate (PEG/Asc) and oral sulfate tablets (OST) as low-volume bowel preparation agents has gradually increased. However, these agents may induce acute gastropathy during bowel preparation, particularly in elderly populations. This study aimed to compare the incidence of acute gastropathy of 1-L PEG/Asc and OST according to age, as well as efficacy and safety. Methods: This retrospective study included patients who underwent esophagogastroduodenoscopy (EGD) and colonoscopy for screening on the same day and underwent bowel preparation using OST or 1-L PEG/Asc. We collected EGD findings related to acute gastropathy, bowel-cleansing score using the Boston Bowel Preparation Scale (BBPS), polyp or adenoma detection rate (ADR), and laboratory parameters. Results: Of 4,711 patients, 1,758, 2,241, and 712 were in the younger (18-49 years), middle-aged (50-64 years), and older (≥65 years) groups, respectively. In all age groups, the OST group had higher rates of acute gastropathy than the 1-L PEG/Asc group. The younger-, middle-, and older-aged groups had OST and 1-L PEG/Asc usage rates of 42.9% and 11.6%, 41.2% and 16.0%, and 41.5% and 16.4%, respectively. Notably, in the younger group, the total BBPS and ADR scores were significantly higher in the OST group than in the 1-L PEG/Asc group; however, these did not differ in the other age groups. Conclusions: Acute gastropathy was more strongly associated with OST than with 1-L PEG/Asc in all age groups. Therefore, physicians should consider acute gastropathy associated with low-volume agents in all age groups when performing bowel preparation.
Assuntos
Ácido Ascórbico , Catárticos , Polietilenoglicóis , Humanos , Pessoa de Meia-Idade , Polietilenoglicóis/efeitos adversos , Polietilenoglicóis/administração & dosagem , Estudos Retrospectivos , Ácido Ascórbico/administração & dosagem , Ácido Ascórbico/uso terapêutico , Idoso , Catárticos/efeitos adversos , Catárticos/administração & dosagem , Masculino , Feminino , Adulto , Adolescente , Fatores Etários , Adulto Jovem , Colonoscopia , Endoscopia do Sistema Digestório , Sulfatos/efeitos adversos , Comprimidos , Administração Oral , Doença AgudaRESUMO
Background/Aims: Utilization of low-volume preparation agents is crucial to improve patient willingness to undergo repeat colonoscopies. However, gastric safety data on preparation agents are limited. This study evaluated the acute gastropathy associated with bowel preparation agents. Methods: This retrospective study enrolled healthy subjects who underwent both esophagogastroduodenoscopy and colonoscopy screening. Baseline patient characteristics, bowel preparation success, acute gastropathy, and polyp and adenoma detection rates were evaluated for 1 L polyethylene glycol with ascorbic acid (1 L PEG/Asc) and oral sulfate tablet (OST) groups. Results: Comparison of the OST group (n=2,463) with the 1 L PEG/Asc group (n=2,060) revealed that the rates of successful cleansing and high-quality cleansing were similar between the two groups. Polyp and adenoma detection rates were significantly higher in the OST group than in the 1 L PEG/Asc group (p<0.001 and p=0.013), while the incidence of acute gastric mucosal lesion-like blood stain/clot, erosions at greater curvature side of antrum/body, multiple erosions, and overlying mucosal erythema or edema were all significantly higher in the OST group than in the 1 L PEG/Asc group (all p<0.001). Additionally, high and indeterminate probability scores of preparation agent-induced gastropathy (p=0.001) and mean Lanza scores were significantly higher in the OST group than in the 1 L PEG/Asc group (1.3 vs. 0.4, p<0.001). Conclusions: Compared with 1 L PEG/Asc, OSTs were significantly associated with acute gastropathy during bowel preparation, thus requiring careful consideration from physicians for the simultaneous screening of EGD and colonoscopy.
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Catárticos , Colonoscopia , Polietilenoglicóis , Humanos , Masculino , Feminino , Catárticos/efeitos adversos , Catárticos/administração & dosagem , Pessoa de Meia-Idade , Polietilenoglicóis/efeitos adversos , Polietilenoglicóis/administração & dosagem , Estudos Retrospectivos , Adulto , Idoso , Ácido Ascórbico/administração & dosagem , Ácido Ascórbico/efeitos adversos , Adenoma/diagnóstico , Endoscopia do Sistema Digestório , Pólipos do Colo/diagnóstico , Pólipos do Colo/patologia , Sulfatos/efeitos adversos , Gastropatias/diagnóstico , Gastropatias/patologia , Gastropatias/etiologia , Gastropatias/induzido quimicamenteRESUMO
Background and aim: Bowel preparation for pediatric colonoscopy presents several challenges. However, no bowel preparation regimen is universally preferred for children. We aimed to investigate the efficacy and safety of oral sulfate tablet (OST) in pediatric bowel preparation. Methods: This study retrospectively analyzed data from children who received 2l of polyethylene glycol and ascorbate (PEG/Asc) or OST for bowel preparation between 2021 and 2023. A comparative analysis was conducted between the two groups. Results: A total of 146 patients were included (2l PEG/Asc: 115, 73.0% vs. OST: 31). No significant difference was observed in the total BBPS score (median 8.0 vs. 8.0, P = 0.152) and the total OBPS score (median 5.0 vs. 3.0, P = 0.152) between the two groups. No significant difference was noted in the ratio of a bubble score of 0 (73.0% vs. 93.5%, P = 0.132). The incidence of abdominal pain was significantly lower in the OST group (32.2% vs. 3.2%, P = 0.002). The VAS score for overall satisfaction was significantly higher in the OST group (4.0 vs. 7.0, P < 0.001). For the next colonoscopy bowel preparation, a higher proportion of patients in the OST group showed a willingness to use the same preparation regimen (33.9% vs. 83.9%, P < 0.001). Conclusion: OST was as efficacious and safe as 2 L of PEG/Asc for pediatric bowel preparation. The satisfaction level was higher with OST than with 2 L of PEG/Asc. OST may be considered a good alternative for children with poor compliance during bowel preparation.
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BACKGROUND AND AIMS: The use of conventional oral sulfate tablets (OSTs) has gained popularity; nonetheless, they may be not only inconvenient to swallow but also difficult to dissolve. A novel mini-OST has recently been developed to enhance compliance with conventional OST use. This study aimed to compare the efficacy, tolerability, and safety between mini-OST and conventional OST. METHODS: This was a prospective, randomized, investigator-blinded, multicenter, and non-inferior phase 3 trial conducted between September 2022 and December 2022. The efficacy, safety, and tolerability were compared between mini-OST and conventional OST. RESULTS: Exactly 83 patients were evaluated based on a full analysis set (FAS), whereas 82 patients were evaluated as a per-protocol set (PPS). With respect to the efficacy of preparation, successful and high-quality preparation was excellent in the mini-OST and conventional OST groups on both FAS and PPS analyses, without significant differences between the two groups. On the FAS analysis, the satisfaction and tolerability scores were high in both groups, without significant differences. The first bowel movement after taking the investigational product occurred 30 min earlier in the mini-OST group than in the OST group. Mild, moderate, and severe adverse events (AEs) were comparable between the two groups; however, any AEs were more common in the mini-OST group than in the conventional OST group overall. CONCLUSIONS: Compared with conventional OST, the novel mini-OST preparation showed similar efficacy, tolerability, and safety, including mild eight solicited AEs and moderate-to-severe AEs. Clinical trial registration NCT05670470.
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BACKGROUND: Efficient bowel preparation is essential for preventing colorectal cancer by improving endoscopic adenoma detection. Tablet for bowel preparation containing sulfate salts, OSTs (oral sulfate tablets), has been developed and it is gaining more popularity. However, its efficacy compared to standard preparation agent, PEG-AA (polyethylene glycol), has not been well discovered. We assessed the efficacy of PEG and OSTs using a real-time clinical data warehouse (CDW) model. METHODS: We performed a propensity score-matched (PSM) analysis of consecutive adult patients undergoing colonoscopy who received PEG-AA or OSTs prior to colonoscopy at a tertiary academic hospital. The endoscopic records of 992 adult patients were retrospectively analyzed. The clinical data warehouse collected data including bowel preparation, insertion time, observation time, and the detection of polyps and adenomas. Multivariate regression analysis was performed to reveal the factors associated with endoscopic outcomes. RESULTS: Among 992 patients included in the study, 770 and 222 patients received PEG-AA and OSTs, respectively. Among the propensity score-matched population (n = 1897), OSTs resulted in better bowel cleansing quality (8.16 vs 7.84, p = 0.014) and a higher adenoma detection rate (38.6% vs 27.1%, p = 0.003). Using PEG-AA, older age, inadequate bowel preparation (BBPS score < 6) and endoscopy by fellows were found to be factors associated with poor adenoma detection. In the elderly over 65 years of age, a significant difference in cleansing quality between the two groups (7.21 vs 8.19, p < 0.001) was found, but its impact on ADR was not prominent (49.5% vs 45.4%, p = 0.653). CONCLUSIONS: OSTs with simethicone achieved better endoscopic cleanliness, improving adenoma detection rate compared to the conventional PEG-AA protocol. The synergistic effect of both the convenience of taking tablets and the reduction of intraluminal bubble by adjunctive simethicone improves the clinical efficacy of colonoscopy.
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Adenoma , Polietilenoglicóis , Adulto , Humanos , Idoso , Polietilenoglicóis/efeitos adversos , Simeticone , Catárticos/efeitos adversos , Sulfatos , Pontuação de Propensão , Estudos Retrospectivos , Colonoscopia/métodos , Adenoma/diagnóstico , Adenoma/induzido quimicamente , ComprimidosRESUMO
The oral sulfate tablet (OST), commercially available as Orafang® (Pharmbio Korea Co., Seoul, Korea) in Korea, is being used increasingly because of its bowel-cleansing efficacy, safety, and tolerability in adults undergoing colonoscopy. Other bowel cleansing agents, such as polyethylene glycol and sodium picosulfate/magnesium citrate, can cause plasma volume depletion and electrolyte disturbances, such as hyponatremia. On the other hand, the OST has never been reported to cause hyponatremia in Korea. To our knowledge, the authors experienced the first case of hyponatremic seizure in an 81-year-old woman to whom an OST was administered for bowel preparation before a colonoscopy. After ingesting the OST, she presented with seizure, confusion, and dyspnea. Upon arrival, her serum sodium level was 120 mEq/L, and the urine osmolality and sodium levels were 449 mOsm/kg and 253 mOsm/kg, respectively; chest imaging suggested pulmonary edema. The associated symptoms disappeared following treatment with an intravenous injection of normal saline and 3% NaCl to normalize the sodium level. This case shows that the OST can cause hyponatremia and other severe complications related to hyponatremia.