BACKGROUND Bowel preparation in children can be challenging.AIM To describe the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, and citric acid(SPMC) bowel preparation in children.METHODS Ph...BACKGROUND Bowel preparation in children can be challenging.AIM To describe the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, and citric acid(SPMC) bowel preparation in children.METHODS Phase 3, randomized, assessor-blinded, multicenter study of low-volume, divided dose SPMC enrolled children 9-16 years undergoing elective colonoscopy. Participants 9-12 years were randomized 1:1:1 to SPMC ? dose × 2, SPMC 1 dose × 2, or polyethylene glycol(PEG). Participants 13-16 years were randomized 1:1 to SPMC 1 dose × 2 or PEG. PEG-based bowel preparations were administered per local protocol. Primary efficacy endpoint for quality of bowel preparation was responders(rating of ‘excellent' or ‘good') by modified Aronchick Scale. Secondary efficacy endpoint was participant's tolerability and satisfaction from a 7-item questionnaire. Safety assessments included adverse events(AEs) and laboratory evaluations.RESULTS 78 participants were randomized, 48 were 9-12 years, 30 were 13-16 years. For the primary efficacy endpoint in 9-12 years, 50.0%, 87.5%, and 81.3% were responders for SPMC ? dose × 2, SPMC 1 dose × 2, and PEG groups, respectively. Responder rates for 13-16 years were 81.3% for SPMC 1 dose × 2 and 85.7% for PEG. Overall, 43.8% of participants receiving SPMC 1 dose × 2 reported it was ‘very easy' or ‘easy' to drink, compared with 20.0% receiving PEG. Treatment-emergent AEs were reported by 45.5% of participants receiving SPMC 1 dose × 2 and 63.0% receiving PEG.CONCLUSION SPMC was an efficacious and safe for bowel preparation in children 9-16 years, with comparable efficacy to PEG. Tolerability for SPMC was higher compared to PEG.展开更多
Understanding the technical constructs of bariatric surgery is important to the treating endoscopist to maximize effective endoluminal therapy. Post-operative complication rates vary widely based on the complication o...Understanding the technical constructs of bariatric surgery is important to the treating endoscopist to maximize effective endoluminal therapy. Post-operative complication rates vary widely based on the complication of interest, and have been reported to be as high as 68% following adjustable gastric banding. Similarly, there is a wide range of presenting symptoms for post-operative bariatric complications, including abdominal pain, nausea and vomiting, dysphagia, gastrointestinal hemorrhage, and weight regain, all of which may provoke an endoscopic assessment. Bleeding and anastomotic leak are considered to be early(< 30 d) complications, whereas strictures, marginal ulcers, band erosions, and weight loss failure or weight recidivism are typically considered late(> 30 d) complications. Treatment of complications in the immediate post-operative period may require unique considerations. Endoluminal therapies serve as adjuncts to surgical and radiographic procedures. This review aims to summarize the spectrum and efficacy of endoscopic management of post-operative bariatric complications.展开更多
文摘BACKGROUND Bowel preparation in children can be challenging.AIM To describe the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, and citric acid(SPMC) bowel preparation in children.METHODS Phase 3, randomized, assessor-blinded, multicenter study of low-volume, divided dose SPMC enrolled children 9-16 years undergoing elective colonoscopy. Participants 9-12 years were randomized 1:1:1 to SPMC ? dose × 2, SPMC 1 dose × 2, or polyethylene glycol(PEG). Participants 13-16 years were randomized 1:1 to SPMC 1 dose × 2 or PEG. PEG-based bowel preparations were administered per local protocol. Primary efficacy endpoint for quality of bowel preparation was responders(rating of ‘excellent' or ‘good') by modified Aronchick Scale. Secondary efficacy endpoint was participant's tolerability and satisfaction from a 7-item questionnaire. Safety assessments included adverse events(AEs) and laboratory evaluations.RESULTS 78 participants were randomized, 48 were 9-12 years, 30 were 13-16 years. For the primary efficacy endpoint in 9-12 years, 50.0%, 87.5%, and 81.3% were responders for SPMC ? dose × 2, SPMC 1 dose × 2, and PEG groups, respectively. Responder rates for 13-16 years were 81.3% for SPMC 1 dose × 2 and 85.7% for PEG. Overall, 43.8% of participants receiving SPMC 1 dose × 2 reported it was ‘very easy' or ‘easy' to drink, compared with 20.0% receiving PEG. Treatment-emergent AEs were reported by 45.5% of participants receiving SPMC 1 dose × 2 and 63.0% receiving PEG.CONCLUSION SPMC was an efficacious and safe for bowel preparation in children 9-16 years, with comparable efficacy to PEG. Tolerability for SPMC was higher compared to PEG.
文摘Understanding the technical constructs of bariatric surgery is important to the treating endoscopist to maximize effective endoluminal therapy. Post-operative complication rates vary widely based on the complication of interest, and have been reported to be as high as 68% following adjustable gastric banding. Similarly, there is a wide range of presenting symptoms for post-operative bariatric complications, including abdominal pain, nausea and vomiting, dysphagia, gastrointestinal hemorrhage, and weight regain, all of which may provoke an endoscopic assessment. Bleeding and anastomotic leak are considered to be early(< 30 d) complications, whereas strictures, marginal ulcers, band erosions, and weight loss failure or weight recidivism are typically considered late(> 30 d) complications. Treatment of complications in the immediate post-operative period may require unique considerations. Endoluminal therapies serve as adjuncts to surgical and radiographic procedures. This review aims to summarize the spectrum and efficacy of endoscopic management of post-operative bariatric complications.
