Improving the tolerability and safety of 1-L polyethylene glycol plus low-dose ascorbic acid for bowel preparation in a healthy population: a randomized multicenter clinical trial.

BACKGROUND AND AIMS: One-liter polyethylene glycol plus ascorbic acid (PEG-ASC) improves patient tolerability, but some patients still show low tolerability to a relatively high content of ASC. This study aimed to improve the tolerability and safety of 1-L PEG with low-dose ASC in comparison with standard 1-L and 2-L PEG-ASC. METHODS: This was a randomized, controlled, double-blinded, multicenter, noninferiority trial involving 215 healthy adults who underwent colonoscopy from June 2020 to January 2021. Efficacy, tolerability, and safety were compared among 1-L PEG with low-dose ASC (50% lower ASC concentration in group A and 25% lower ASC concentration in groups B and C) and standard 1-L and 2-L PEG-ASC with all split regimens. RESULTS: One-liter PEG with low-dose ASC (groups A-C) had similar bowel cleansing efficacies according to the Harefield Cleansing Scale and Boston Bowel Preparation Scale, without negative clinical performance, compared with standard 1-L and 2-L PEG-ASC preparation (all P > .1). One-liter PEG with low-dose ASC had better tolerability compared with 2-L PEG-ASC and less residual fluid retention in the stomach compared with 1-L PEG-ASC, proportional to the amount of ASC. No significant differences were found in the incidences of overall adverse events, mild adverse events, or death or in the occurrence of gastroduodenal erosion or ulcer in upper endoscopy. CONCLUSIONS: One-liter PEG with low-dose ASC (25%-50% reduction in dose) for bowel cleansing showed similar efficacy and safety compared with standard 1-L or 2-L PEG-ASC, better tolerability compared with 2-L PEG-ASC, and less residual gastric fluid retention compared with standard 1-L PEG-ASC. (Clinical trial registration number: KCT0005490.).

A Randomized Controlled Trial Comparing Colonoscopic Enema With Additional Oral Preparation as a Salvage for Inadequate Bowel Cleansing Before Colonoscopy.

GOALS: The goal of this study was to evaluate the noninferiority of colonoscopic enema to additional oral preparation in salvage bowel cleansing for inadequate preparation for a morning colonoscopy. BACKGROUND: Colonoscopic enema, administering additional cathartics into the right colon through the colonoscope accessory channel, is suggested to rescue poor bowel preparation for a colonoscopy but lacking comparative study. STUDY: In this prospective, randomized, actively-controlled, parallel group, noninferiority trial, consecutive outpatients and health checkup recipients aged from 19 to 70 years with inappropriate bowel preparation during an elective colonoscopy were enrolled to receive either a colonoscopic enema of 1 L polyethylene glycol (PEG) (enema group) or additional oral intake of 2 L PEG (oral group). The primary endpoint was the proportion of adequate bowel preparation evaluated using the Boston Bowel Preparation Scale. RESULTS: Overall, 131 participants were randomized. Adequate bowel preparation was achieved in 53% (35/66) of the enema group, which was significantly inferior to the oral group (81.5%; 53/67) with a difference of -28.5% (95% confidence interval, -44.1, -12.9; P=0.001). The largest difference in the proportion of adequate bowel preparation was observed in the right colon (57.8% in the enema group vs. 86.9% in the oral group; P<0.001), followed by the transverse colon (85.9% vs. 98.4%; P=0.017) and the left colon (90.6% vs. 96.7%; P=0.274). CONCLUSIONS: The colonoscopic enema of 1 L PEG was inferior to the additional oral ingestion of 2 L PEG regarding efficacy as a salvage bowel preparation in adults with inadequate bowel cleansing for colonoscopy.

Bio-sheet graft therapy for artificial gastric ulcer after endoscopic submucosal dissection: an animal feasibility study.

BACKGROUND: Various bio-sheet grafts have been attempted either to accelerate healing of artificial ulcers or to prevent adverse events after endoscopic submucosal dissection (ESD), but neither prospective nor mechanistic studies were available. OBJECTIVE: To evaluate the substantial effect of a bio-sheet graft on artificial ulcer healing and its feasibility as an endoscopic treatment modality. DESIGN: Preclinical, in vivo animal experiment and proof-of-concept study. SETTING: Animal laboratory. SUBJECTS: Three mini-pigs, Sus scrofa, mean age 14 months. INTERVENTION: Multiple ulcers sized 2.5 cm in diameter were generated by ESD in 3 mini-pigs and were assigned randomly into the following 3 groups; control group, bio-sheet group, or combination (bio-sheet plus drug) group. Bio-sheet grafts or bio-sheet plus drug combinations were applied on the artificial ulcers immediately after the ESD. MAIN OUTCOME MEASUREMENTS: Feasibility and efficacy of endoscopic bio-sheet graft therapy for the management of artificial ulcers and the evaluation of healing conditions based on histology changes in the remaining gastric bed tissues harvested from the stomachs. RESULTS: Thirty-three ESD specimens were obtained. On an image analysis of the ratio of healed area in the remaining gastric bed tissue compared with the matched dissected gastric mucosa, the control group showed the most significant improvement in healing activity among the 3 groups (P < .05), whereas the severity of inflammation in the remaining ulcer tissue was significantly attenuated in bio-sheet and combination groups (P < .05). LIMITATIONS: Animal model. CONCLUSION: Although the bio-sheet grafts provided physical protection from gastric acid attack as reflected in the attenuated inflammation on the ulcer beds, unexpected delayed ulcer healing was noted in the bio-sheet graft group because of its physical hindrance of the healing process.

Efficacy, tolerability, and safety of oral sulfate tablet versus 2 L-polyethylene glycol/ascorbate for bowel preparation in older patients: prospective, multicenter, investigator single-blinded, randomized study.

BACKGROUND: We compared the efficacy, tolerability, and safety of oral sulfate tablets (OST, which contains simethicone) and 2 L-polyethylene glycol/ascorbate (2 L-PEG/Asc) with a split-dosing regimen in older individuals aged ≥ 70 years who underwent scheduled colonoscopy. METHODS: This prospective, randomized, investigator-blinded, multicenter study was conducted between June 2022 and October 2023. Participants aged ≥ 70 years were randomized at a ratio of 1:1 to the OST or 2 L-PEG/Asc groups. RESULTS: In total, 254 patients were evaluated using a modified full analysis set. Successful overall bowel preparation was excellent and similar between the OST and 2 L-PEG/Asc groups for the Boston Bowel Preparation Scale (BBPS) (96.5% vs. 96.6%) and Harefield Cleansing Scale (HCS) (96.5% vs. 97.4%). The overall high-quality preparation rate was higher in the OST group than in the 2 L-PEG/Asc group (BBPS: 55.7% vs. 28.4%, P < 0.001; HCS: 66.1% vs. 38.8%, P < 0.001). The overall adenoma detection rate (54.8% vs. 35.3, P = 0.003) was superior in the OST group compared to the 2 L-PEG/Asc group. Tolerability scores, including overall satisfaction, were generally higher in the OST group than in the 2 L-PEG/Asc group. The incidence of major solicited adverse events was comparable between the two groups (55.7% vs. 68.1, P = 0.051), and there were no clinically significant changes in the serum laboratory profiles on the day of or 7 days after colonoscopy. CONCLUSIONS: OST is an effective and safe low-volume agent for colonoscopy, with better tolerance than 2 L-PEG/Asc, in older individuals aged ≥ 70 years.

Evaluation of the efficacy of 1 L polyethylene glycol plus ascorbic acid and an oral sodium sulfate solution: A multi-center, prospective randomized controlled trial.

INTRODUCTION: Low-volume bowel preparation has been developed to increase patient compliance. We compared 1 L of polyethylene glycol/ascorbic acid (PEG/Asc) and oral sodium sulfate (OSS) with respect to bowel preparation efficacy, compliance, and safety. METHODS: A multicenter, prospective, randomized, single-blinded, non-inferiority trial was conducted in 3 hospitals. Patients were randomized to receive a bowel-cleansing agent. Bowel-cleansing efficacy was evaluated using the Boston Bowel Preparation Scale (BBPS). Satisfaction, feeling, taste of the bowel cleanser, and adverse events after taking the bowel cleanser were investigated through a questionnaire. Additionally, blood samples were analyzed before and after bowel cleansing. RESULTS: In total, 172 patients were analyzed (85 with 1 L PEG/Asc and 87 with OSS), and the mean BBPS scores were comparable between agents. The 1L PEG/Asc group tended to have a higher BBPS score in the right colon (2.22 vs 2.02; P = .08). The compliance of 1 L of PEG/Asc was comparable to that of OSS. Patients taking 1 L PEG/Asc reported greater thirst and dizziness (P = .04 and P = .047, respectively) than the OSS cohort. On the other hand, gastrointestinal symptoms such as vomiting and abdominal distension were more common in the OSS group, without statistical significance. In terms of laboratory adverse events, elevation of serum creatinine was found in both groups after taking the bowel cleansing agent (P < .001 for the 1L PEG/Asc group; P = .04 for the OSS group). However, most of the increased values were within the normal ranges. DISCUSSION: The 1L PEG/Asc treatment was comparable to OSS in terms of bowel preparation efficacy, compliance, and safety.

Efficacy of full-thickness GI perforation closure with a novel over-the-scope clip application device: an animal study.

BACKGROUND: A novel, over-the-scope clip (OTSC) system may be suitable for closure of various GI perforations. The strength and maximum diameter of closure for a single OTSC, however, are unknown. OBJECTIVE: To determine the maximum closure capacity (diameter) and pressure threshold for a single OTSC. DESIGN: Prospective ex-vivo study. SETTING: Academic medical center. METHOD: Full-thickness, standardized defects of 5 mm, 10 mm, 15 mm, 20 mm, and 25 mm were created in porcine stomachs. Similarly, full-thickness defects of 10 mm, 20 mm, 25 mm, 30 mm, and 35 mm were created in porcine colons. A single OTSC was endoscopically deployed 5 times for each full-thickness defect size in an ex-vivo endoscopic simulator. MAIN OUTCOME MEASUREMENTS: Each closure site was tested under water with compressed air for burst pressure. RESULTS: We achieved successful closure in all stomach defects ranging from 5 to 20 mm by using 12-mm OTSCs with short teeth and colon defects ranging from 10 to 30 mm with 14-mm OTSCs with short teeth. Mean (± standard deviation [SD]) burst pressures for the gastric closure sites were 74.9 ± 17.5 mm Hg for 15-mm defects, 49.3 ± 21.6 mm Hg for 20-mm defects, and 15.2 ± 4.1 mm Hg for 25-mm defects. Mean (± SD) burst pressures for the colon closure sites were 117.9 ± 40.1 mm Hg for 20-mm defects, 57.4 ± 4.2 mm Hg for 30-mm defects, and 10.9 ± 7.6 mm Hg for 35-mm defects. LIMITATIONS: Ex-vivo study, does not reflect difficult locations. CONCLUSION: Full-thickness tissue defects ranging from 5 to 20 mm in the stomach and from 10 to 30 mm in the colon can be closed adequately with a single OTSC in an ex-vivo experimental setting. Tissue defects larger than 20 mm in the stomach and 30 mm in the colon may require more than one OTSC or supplemental endoclips to achieve adequate closure. Endoscopic inspection of the closure site does not assure adequate closure of larger perforations.