Low-volume Polyethylene Glycol Research Articles

Efficacy and safety of a new low-volume PEG with citrate and simethicone bowel preparation for pediatric elective colonoscopy: Phase 3 RCT.

Background and study aims Currently available polyethylene glycol (PEG)-based preparations continue to represent a challenge in children. The aim of this study was to compare the efficacy and safety of a new low-volume PEG preparation with a conventional PEG-electrolyte solution (PEG-ES) in children and adolescents. Patients and methods This was a multicenter, randomized, observer-blind, parallel-group, phase 3 clinical trial, where patients were randomized between PMF104 (Clensia) and a conventional PEG-ES (Klean-Prep), and stratified by age stratum (2 to <6; 6 to < 12;12 to <18 years). The primary endpoint was to test the non-inferiority of PMF104 versus PEG-ES, in terms of colon cleansing. Safety, tolerability, acceptability, palatability, and compliance were also assessed. Efficacy endpoints were analyzed in the per protocol set (PPS) and full analysis set (FAS) and safety and tolerability endpoints in the safety set (SAF). Results Of the 356 patients enrolled, 258 were included in the PPS, 346 in the FAS, and 351 in the SAF. Non-inferiority of PMF104 was confirmed for children aged > 6 years and for all age groups in PPS and FAS, respectively. Optimal compliance was reported more frequently in the PMF104 than in the PEG-ES group, in both PPS (86.1% vs. 68.4%) and FAS (82.9% vs. 65.3%). Both preparations were equally safe and tolerable. Palatability and acceptability were considered better in the PMF104 group than in the PEG-ES group (27.1% vs. 15.3% and 15.3% vs. 3.5%, respectively). Conclusions In children aged 6 to 17 years, the new low-volume product PMF104 is non-inferior to the reference PEG-ES in terms of bowel cleansing, safety, and tolerability, with slightly better results in compliance, palatability, and acceptability.

A Novel Model to Predict Inadequate Bowel Preparation Prior to Colonoscopy Incorporating Patients’ Reactions to Drinking the Laxative

Background and Aims: Prior studies have identified predictors of inadequate preparation with limited success. We aimed to build a model that could predict the likelihood of inadequate preparation by also including factors related to the patient’s reaction to drinking the laxative preparation. Methods: Demographic, clinical, and preparation-related data were prospectively collected on patients undergoing colonoscopy. An inadequate preparation was defined as a Boston Bowel Preparation Scale &lt; 6. Statistical analyses were performed to identify predictors of inadequate preparation and create a predictive model. Results: 324 patients were included (age 67 +/− 14 years, 52% male). 77 (23.7%) had inadequate preparations. Diabetes (p &lt; 0.001), cerebrovascular accident (CVA) (p &lt; 0.001), incomplete prep consumption (p = 0.007), high school level education and above (p &lt; 0.001), use of Bisacodyl (p = 0.005), &gt;10 bowel movements (p = 0.02), and use of Sodium Picosulfate or low-volume polyethylene glycol (PEG) solution (2L) compared to PEG 3L (p &lt; 0.001) were significant variables. In a multivariate analysis, prior CVA increased the risk for inadequate preparation (OR = 4.8, CI 1.6–14.5), whereas high school level education and above (OR = 0.4, CI 0.2–0.8), consumption of Bisacodyl (OR = 0.4, CI 0.2–0.8), &gt;10 bowel movements (OR = 0.5, CI 0.3–0.9), and use of Sodium Picosulfate (OR = 0.5, CI 0.3–0.9) decreased the risk for inadequate prep. Using these, a predictive model for patients likely to have an inadequate colon preparation was created with an area under the curve of 0.74 (35% sensitivity, 90% specificity at a cutoff point of 39%). Conclusion: Given the low sensitivity, this predictive model does not appear ready for clinical use. However, due to its high specificity, it may be helpful in high-risk, sicker populations by preventing inadequately prepped procedures.

Comparing Low Volume Versus Conventional Volume of Polyethylene Glycol for Bowel Preparation during Colonoscopy: A Randomised Controlled Trial.

Polyethylene glycol (PEG) solution is widely used as a colonoscopic bowel cleaning agent, although some patients are intolerant due to the need for ingesting large solution volumes and unpleasant taste. A low-volume solution may enhance patient tolerability and compliance in bowel preparation. Accordingly, this study compared the effectiveness of two difference PEG volumes for bowel preparation before colonoscopy in terms of bowel cleanliness, completeness of colonoscopy, patient tolerability and colonoscopy duration. Using a prospective randomised controlled single-blinded study design, 164 patients scheduled for colonoscopy were allocated to two groups (n = 82 patients in each) to receive either the conventional PEG volume (3 L, control group) or the low volume (2 L, intervention group). The Boston Bowel Preparation Scale (BBPS), a validated scale for assessing bowel cleanliness during colonoscopy, was used to score bowel cleanliness in three colon segments. Secondarily, colonoscopy completeness, tolerability to drinking PEG and the duration of colonoscopy were compared between the groups. There were no statistically significant differences between the two intervention groups in terms of bowel cleanliness (P = 0.119), colonoscopy completion (P = 0.535), tolerability (P = 0.190) or the amount of sedation/analgesia required (midazolam, P = 0.162; pethidine, P = 0.708). Only the duration of colonoscopy differed between the two groups (longer duration in the control group, P = 0.039). Low-volume (2 L) PEG is as effective as the standard 3 L solution in bowel cleaning before colonoscopy; however, the superiority of either solution could not be established.

Suflave - a low-volume colonoscopy preparation.

The FDA has approved Suflave (Sebela/Braintree), a low-volume polyethylene glycol (PEG)- and sulfate-based product for cleansing of the colon prior to colonoscopy in adults. Suflave is marketed as tasting better than other products.

Importance of Bowel Habits in Predicting Inadequate Bowel Preparation: A Prospective Observational Study.

Inadequate bowel preparation (BP) negatively affects the efficacy and quality of colonoscopy. Although constipation has already been reported as one of the most important predictors of inadequate BP, there is limited information on the relation between inadequate BP and bowel habits including constipation-related symptoms, medications, and severity of constipation. This single-center, prospective observational study was conducted between August 2019 and May 2020. All participants answered questionnaires regarding personal bowel habits and received low-volume polyethylene glycol plus ascorbic acid for outpatient colonoscopy. Severity of constipation was evaluated by constipation scoring system. Bowel preparation cleansing was evaluated using Boston Bowel Preparation Scale (BBPS). Potential predictors of inadequate BP were analyzed using multivariate logistic regression models. Overall, 1054 patients were enrolled, of which, 105 (10%) had inadequate BP (total BBPS ≤ 6 or any segmental BBPS < 2). The risk of inadequate BP increased with constipation severity (P = 0.01). Multivariate analysis showed that frequent straining (> 25% of defecations) (OR 2.09, 95% CI: 1.33-3.28) and chronic use of stimulant laxatives (OR 2.57, 95% CI: 1.59-4.17) were significant predictors of inadequate BP, among personal bowel habits. Frequent straining and chronic use of stimulant laxatives were predictors of inadequate BP. An intensified preparation regimen should be considered for severely constipated patients with straining and chronic use of stimulant laxatives.

The safety and effects of high- and low-volume polyethylene glycol bowel preparation methods before colonoscopy on bowel cleanliness: a systematic review and meta-analysis.

Although both high- and low-volume polyethylene glycol (PEG) are widely used in intestinal preparation before colonoscopy, there is still controversy over the superiority of their cleaning effects. This meta-analysis sought to explore the safety and effects of high-volume PEG solution and low-volume PEG mixed solution on intestinal cleanliness before colonoscopy. The PubMed, EMBASE, and Cochrane Library databases were searched to retrieve relevant articles on the effects of high- and low-volume PEG mixture solutions on intestinal cleanliness from the inception of the databases to October 15, 2022. Two independent researchers screened the literature according to the predetermined inclusion and exclusion criteria, and extracted the required data separately. A bias risk assessment was conducted for each study using the relevant tools in the Cochrane Handbook. The included data were subjected to a meta-analysis using R 4.2.1 software. This article includes a total of 15 studies involving a total of 5,847 patients. There was no difference in the cleanliness score, qualified rate of intestinal cleanliness and patient compliance between the high- and low-volume group. The patients in the low-volume PEG mixed solution group had a higher repeat willingness bowel cleansing rate than those in the high-volume PEG group [risk ratio (RR) =0.71, 95% confidence interval (CI): 0.62-0.82, P<0.01]. Compared with the low-volume group, the incidence of adverse reactions such as nausea, vomiting, and abdominal pain increased in the high-volume group (RR =1.38, 95% CI: 1.22-1.56, P<0.01; RR =1.79, 95% CI: 1.41-2.27, P<0.01; RR =1.05, 95% CI: 1.01-1.08, P<0.01). In the pre-colonoscopy preparation method for patients, although the high-volume PEG and low-volume PEG mixed regimen have similar effects on intestinal cleanliness, the low-volume mixed regimen has a higher willingness to repeat and a lower incidence of adverse reactions. In clinical practice, considering patient compliance and safety, a low-volume mixed regimen may be a more optimal option.

Observation of the application effect of low-volume polyethylene glycol electrolyte lavage solution (PEG-ELS) combined with ascorbic acid tablets in bowel preparation for colonoscopy in hospitalized patients

This study explored the effectiveness and safety of low-volume polyethylene glycol electrolyte lavage solution (PEG-ELS) combined with ascorbic acid tablets (PEG-ELS/Asc) in bowel preparation for a colonoscopy. A total of 240 hospitalized patients who underwent a colonoscopy in Wenzhou People's Hospital, Wenzhou Third Clinical College of Wenzhou Medical University from July 2020 to June 2022 were randomly divided into two groups, with 120 patients each. All of the participants were given a low-residue or residue-free diet one day before the examination and fasted after dinner (completed before 18:00) the day before the examination. The 2-L PEG-ELS/Asc group took 2-L PEG-ELS plus 10g ascorbic acid tablets once orally, while the 3-L PEG-ELS group took 3-L PEG orally on several occasions. The primary endpoint was the achievement of preparation adequacy and an overall colon cleansing score of ≥6, both assessed by blinded investigators using the Boston Bowel Preparation Scale (BBPS). The bowel cleansing effect, polyp detection rate, adverse reaction rate, oral drug tolerance rate, renal function, and electrolyte level changes were also compared between the two patient groups. There were no significant differences in the success rate of bowel preparation, the detection rate of polyps, or the adverse reaction rate between the two groups (P > 0.05). The tolerance rate of bowel preparation in the 2-L PEG-ELS/Asc group was significantly higher than that in the 3-L PEG-ELS group (93.3% vs. 80.23%) (P < 0.05). The levels of creatinine, serum potassium, serum sodium, and serum chlorine of the two groups before and after bowel preparation were within the normal range. In addition, the intestinal cleaning effect of the two preparation schemes for the hospitalized patients with diabetes and constipation is worse than that of those without these conditions (P < 0.05). The effectiveness and safety of using 2-L PEG-ELS/Asc in bowel preparation for a colonoscopy in hospitalized patients were not inferior to using 3-L PEG-ELS. For patients with diabetes and constipation, the cleansing effect of the two bowel preparation options was not very satisfactory, and further clinical research is needed in this regard.

Factors affecting the quality of bowel preparation for colonoscopy in hard-to-prepare patients: Evidence from the literature

Adequate bowel cleansing is critical for a high-quality colonoscopy because it affects diagnostic accuracy and adenoma detection. Nevertheless, almost a quarter of procedures are still carried out with suboptimal preparation, resulting in longer procedure times, higher risk of complications, and higher likelihood of missing lesions. Current guidelines recommend high-volume or low-volume polyethylene glycol (PEG)/non-PEG-based split-dose regimens. In patients who have had insufficient bowel cleansing, the colonoscopy should be repeated the same day or the next day with additional bowel cleansing as a salvage option. A strategy that includes a prolonged low-fiber diet, a split preparation regimen, and a colonoscopy within 5 h of the end of preparation may increase cleansing success rates in the elderly. Furthermore, even though no specific product is specifically recommended in the other cases for difficult-to-prepare patients, clinical evidence suggests that 1-L PEG plus ascorbic acid preparation are associated with higher cleansing success in hospitalized and inflammatory bowel disease patients. Patients with severe renal insufficiency (creatinine clearance < 30 mL/min) should be prepared with isotonic high volume PEG solutions. Few data on cirrhotic patients are currently available, and no trials have been conducted in this population. An accurate characterization of procedural and patient variables may lead to a more personalized approach to bowel preparation, especially in patients undergoing resection of left colon lesions, where intestinal preparation has a poor outcome. The purpose of this review was to summarize the evidence on the risk factors influencing the quality of bowel cleansing in difficult-to-prepare patients, as well as strategies to improve colonoscopy preparation in these patients.

Efficacy and tolerability of 1L polyethylene glycol plus ascorbic acid with senna versus 2L polyethylene glycol plus ascorbic acid for colonoscopic bowel preparation: Prospective, randomized, investigator-blinded trial.

Low-volume polyethylene glycol plus ascorbic acid (PEG-Asc) reduces the dosage of colonoscopic bowel preparation (BP) solution, but is still poorly tolerated. Adding laxatives to the BP solution reduces the volume of fluid required, without affecting quality. This study aimed to compare 1L PEG-Asc plus 24 mg senna (1L-PEG/AS) and conventional 2L PEG-Asc (2L-PEG/A) regimens on BP quality and patient tolerability. A single-center, randomized, investigator-blinded, noninferiority trial was performed between June and August 2022. Outpatients scheduled for colonoscopy were randomized (1:1) to the 1L-PEG/AS or 2L-PEG/A group. The Boston Bowel Preparation Scale (BBPS) was used to evaluate BP quality. Adverse events and tolerability were surveyed using questionnaires. Overall, 344 patients received 1L-PEG/AS or 2L-PEG/A regimens. The baseline characteristics and adverse events of the two groups were comparable. The 1L-PEG/AS group showed noninferior adequate BP rates compared with the 2L-PEG/A group (88% vs. 89%, P=1.00); overall BBPS was 7.1 ± 1.5 and 7.2 ± 1.5, respectively (P=0.39). Higher willingness to repeat the BP was observed in the 1L-PEG/AS group (85% vs. 62%, P < 0.01). The 1L-PEG/AS regimen was comparable to the 2L-PEG/A regimen in terms of BP adequacy, requiring lower BP solution volumes, with better patient tolerance. Thus, it may be a suitable alternative to the conventional BP solution for colonoscopy. The Japan Registry of Clinical Trials (jRCT1051220043).

The Effectiveness of a Very Low-Volume Compared to High-Volume Laxative in Colon Capsule Endoscopy

Colon capsule endoscopy (CCE) is a promising modality for colonic investigations, but completion rates (CR) and adequate cleansing rates (ACR) must be improved to meet established standards for optical colonoscopy. Improvements should be made with patient acceptability in mind. We aimed to compare a very low-volume polyethylene glycol (PEG) laxative to a conventional high-volume laxative. We carried out a single-center retrospective comparative cohort study including patients referred for CCE. One hundred and sixty-six patients were included in the final analysis, with eighty-three patients in each group. We found a CR and ACR of 77% and 67% in the high-volume group and 72% and 75% in the very low-volume group, respectively. In the high-volume group, 54% had complete transit and adequate cleansing, whereas this was the case for 63% in the very low-volume group. No statistically significant difference in CR, ACR, or a combination of the two was found. A very low-volume bowel preparation regimen was non-inferior to a high-volume regimen before CCE in terms of CR and ACR.

Low volume polyethylene glycol combined with senna versushigh volume polyethylene glycol, which regimen is better for bowel preparation for colonoscopy? A randomized, controlled, and single-blinded trial.

Background and AimsBowel preparation affects the quality of colonoscopy. Reaching the optimal preparation has been a challenge for years. Polyethylene glycol (PEG) is the sole FDA‐approved substance for this purpose. However, patients find it unpleasant and often complain about its adverse effects. In this study, we aimed to reduce these complaints by lowering the amount of PEG and adding senna which is an herbal stimulant laxative.MethodsFour hundred and eighty‐six patients were admitted for colonoscopy. Finally, 382 patients were enrolled in the study and we divided them into two groups; 186 patients were placed in which conventional high volume PEG‐alone regimen was consumed and 196 patients in which low volume PEG plus senna regimen was offered. The quality of colon preparation was compared between the two groups by independent two samples t‐test (or its corresponding nonparametric test), Fisher's exact, or χ 2 test in SPSS software version 22.ResultsThe colon preparation quality was equally efficient in the two groups as 69.36% in the high volume PEG group and 71.94% in PEG plus senna group had adequate bowel preparation (p = 0.58). Adverse effects, like nausea, bloating, headache, and sleeplessness were significantly less in the low volume PEG plus senna group.ConclusionBesides the fact that bowel preparation by low volume PEG plus senna combination was noninferior to the conventional high volume PEG‐alone regimen, the side effects were much less common with the low volume PEG plus senna regimen.

A retrospective, comparative study between Plenvu and Moviprep as bowel preparation agents for colonoscopy

Optimal bowel preparation is crucial for a successful colonoscopy. Plenvu is a low volume (1 litre) polyethylene glycol (PEG) plus ascorbate-based bowel preparation which has demonstrated a superior cleansing and equal safety and tolerability profile compared with standard agents.[1,2][1] The

Use of Insoluble Dietary Fiber and Probiotics for Bowel Preparation Before Colonoscopy: A Prospective Study.

Background:In screening colonoscopy, patients usually have to ingest large amounts of bowel-cleansing agents, including polyethylene glycol (PEG). This is difficult and has various side effects; thus, patients avoid undergoing a colonoscopy. We tested a novel bowel preparation method before colonoscopy using insoluble dietary fiber and probiotics (PB).Methods:This was a prospective clinical study conducted between October 2018 and March 2019 at a general hospital. Forty participants were randomly assigned to low-volume PEG solution diet (MoviPrep), wheat bran fiber (WBF) and probiotic Bifidobacterium animalis subsp. lactis GCL2505 (PB GCL2505), or standard-volume regimen (1.0 to 1.5 L of MoviPrep) (control group). The patient compliance and the quality of bowel preparation were evaluated.Results:Forty individuals aged 38 to 83 years were randomly assigned to the WBF with PB (n=20) and control (n=20) groups. All participants underwent bowel preparation before colonoscopy according to each protocol. The mean required volume of MoviPrep was significantly lower in the WBF with PB group than in the control group (582.5 vs. 1305 mL, P<0.0001). Successful bowel-cleansing rates were not significantly different between the 2 groups; however, the ratio of the Harefield Cleansing Scale grades C and D was significantly lower in the WBF with PB group than in the control group (P=0.0471).Conclusions:The intake of WBF and GCL2505 before colonoscopy reduces the required PEG quantities while maintaining bowel-cleansing quality. This novel, minimally invasive pretreatment method makes colonoscopy more accessible contributing to the prevention and early treatment of colorectal cancer.

P233 Efficacy and safety of oral sulfate tablet for the bowel preparation in patients with inflammatory bowel disease: multicenter randomized controlled study

Abstract Background Although high and low volume polyethylene glycol(PEG) bowel preparations are recommended for patients with inflammatory bowel disease(IBD) before colonoscopy, sometime it is limited due to poor compliance. So, studies regarding novel low volume preparations in IBD are need, but, there is limited data. We aimed to evaluated the safety, tolerability and efficacy of oral sulfate tablet (OST) by comparison with 2L PEG and ascorbate (PEG/Asc) in patients with IBD. Methods One hundred ten patients with IBD were enrolled in this single-blind, multicenter, non-inferiority study. Patients were assigned either 2L PEG/Asc or OST to be administered in a split-dose regimen. OST patients were administered 14 tablets with more than 1L of free water in the evening, and the following morning. Colonoscopies were performed by blinded investigators. The primary efficacy endpoint was successful bowel cleansing rate, defined as Harefield Cleansing Scale grade A or B as evaluated by blinded endoscopist in each hospital. Secondary endpoints included the presence of residual air bubbles. Adverse events and laboratory evaluations were monitored to assess safety. Flare up of IBD symptoms and mucosa change associated with preparation were also evaluated. Tolerability, in terms of taste and degree of resistance to drink was assessed with VAS score by interview before colnoscopy. Safety was assessed by spontaneously reported adverse events, solicited ratings of expected prep symptoms, and laboratory testing. Results The cleansing score at all the segment was significantly higher in OST group. A high rate of cleansing success was seen with OST (98.1%), which was noninferior to 2L PEG/Asc (98.1%). Proportion of patients with bubble score 0 was significantly higher in OST than 2L PEPG/Asc group (94.5% vs. 50.0%, p&amp;lt;0.001). Satisfaction, in terms of easiness to drink (8.2 ± 1.6 vs. 6.0 ± 2.2, p&amp;lt;0.001) and taste(7.0 ± 2.8 vs. 5.4 ± 2.4, p=0.002) was significantly higher in OST group. More patients in OST group (94.5%) wanted to repeat the same preparation next colonoscopy. There was no significant difference in the development of vomiting and bloating between group. Aphthous ulcers were noted in the same number of patients in both group and symptom flare up were noted in 2 cases of OST group (p=1.000). No clinically significant differences were seen between preps for renal function and serum electrolyte. Conclusion Oral sulfate tablets achieved a high level of cleansing comparable with 2L PEG/Asc in patients with IBD. The risk of mucosal change or symptom relapse were not higher, on the other hand the degree of satisfaction was higher than 2L PEG/Asc. OST split method could be considered as one of the preparation method for patients with inactive IBD.

A Randomized Study Comparison between Split Dosage and Non-Split Dosage PEG-Electrolyte Solution Preparation Methods for Elective Colonoscopy

Background: A two liters low volume polyethylene glycol (PEG) electrolyte solution preparation was proposed for improving patients’ tolerability with either split or non-split dosage cleansing method. Patient compliance, adverse experiences, and cleansing efficacy of each anatomical segment of the colon using both methods should be determined. Objective: To assess the cleansing efficacy of split dosage versus non-split dosage PEG-electrolyte solution for each anatomical segment of the colon according to the inverted Ottawa bowel preparation scale. Materials and Methods: The present study was a prospective, randomized, endoscopist-blinded study. Volunteers that underwent elective screening colonoscopy were eligible for recruitment into the present study. Patients having any contraindication for colonoscopy, or the use of PEG-electrolyte solution such as bowel obstruction, intestinal perforation, or toxic megacolon were excluded. Cleansing efficacy was evaluated by the inverted Ottawa bowel preparation scale for each anatomical segment of the colon. Medical adherence and compliance were evaluated. Participants were asked to rate their satisfaction and inform the presence of any adverse experiences related to the bowel preparation method. Results: Ninety-four volunteers were randomly assigned to two groups. Of these, 46 received the split dosage cleansing method and 48 received the non-split dosages cleansing method. Overall compliance was approximately 94%, comparable for both preparation methods. Average age was 61.5 years for non-split dosage and 60.4 for split dosage group. Satisfaction score in the non-split dosage group was 8.46, which was not significantly different from 8.56 of the split dosage group (p=0.934). Split dosage PEG-electrolyte solution provided comparable degree of cleansing as standard non-split dosages preparation for transverse, descending, sigmoid, and rectum. However, split dosage provided significantly superior cleansing results over the non-split dosages method for ascending colon at good or excellent with 84.7% versus 47.9% (p&lt;0.01), and caecum at good or excellent for 76.1% versus 41.7% (p&lt;0.01) based on the inverted Ottawa bowel preparation scale. Conclusion: Split dosage PEG-electrolyte solution method provided significantly superior cleansing results over the non-split dosages method for right-side colon with comparable satisfaction score and rate of adverse events. Keywords: Bowel preparation; Split dosage cleansing; Quality of bowel preparation

Oral sulfate solution versus low-volume polyethylene glycol for bowel preparation: Meta-analysis of randomized controlled trials.

Oral sodium sulfate (OSS) solution and low-volume polyethylene glycol-based solutions are two of the more common low-volume purgatives used as colonoscopy preparations. Data on how these different low-volume solutions compare are mixed. Our aim was to conduct a meta-analysis of randomized controlled trials (RCTs) to compare OSS with low-volume polyethylene glycol solutions (PEG) plus ascorbic acid (PEG + Asc) solution with respect to (i) satisfactory bowel preparation, (ii) excellent bowel preparation, and (iii) tolerability. Studies were identified by searching 10 medical databases for reports published from 1974 until 2019. Only fully published RCTs comparing OSS and low-volume PEG-based products with regard to overall satisfactory bowel preparation were included. Pooling was conducted by both fixed-effects and random effects models; results are presented from the random effects model when heterogeneity was significant. Seven studies (involving 2049 subjects) met the inclusion criteria. There was no difference between OSS and PEG + Asc with respect to adequate bowel preparation (risk ratio [RR] 1.02 [0.99-1.06]; P = 0.16). OSS did result in a higher chance of excellent bowel preparation (RR 1.18 [1.06-1.31]; P = 0.03). OSS was associated with a 30% increased risk of nausea (RR 1.35 [1.03-1.77]; P = 0.03) and more than double the risk of vomiting (RR 2.30 [1.63-2.23]; P < 0.05) compared with PEG + Asc. Begg's funnel plot indicated low probability of publication bias. Individuals at low risk of inadequate bowel preparation who use OSS for bowel preparation are more likely to achieve excellent bowel preparation, but are more likely to experience nausea and vomiting than are individuals using low-volume PEG-based solutions.

Lavage, Simethicone, and Prokinetics—What to Swallow with a Video Capsule

The development of new capsules now allows endoscopic diagnosis in all segments of the gastrointestinal tract and comes with new needs for differentiated preparation regimens. Although the literature is steadily increasing, the results of the conducted trials on preparation are sometimes conflicting. The ingestion of simethicone before gastric and small bowel capsule endoscopy for prevention of air bubbles is established. The value of a lavage before small bowel capsule endoscopy (SBCE) is recommended, although not supported by all studies. Ingestion in the morning before the procedure seems useful for the improvement of mucosa visualization. Lavage after swallowing of the capsule seems to improve image quality, and in some studies also diagnostic yield. Prokinetics has been used with first generation capsules to shorten gastric transit time and increase the rate of complete small bowel visualization. With the massively prolonged battery capacity of the new generation small bowel capsules, prokinetics are only necessary in significantly delayed gastric emptying as documented by a real-time viewer. Lavage is crucial for an effective colon capsule or pan-intestinal capsule endoscopy. Mainly high or low volume polyethylene glycol (PEG) is used. Apart from achieving optimal cleanliness, propulsion of the capsule by ingested boosts is required to obtain a complete passage through the colon within the battery lifetime. Boosts with low volume sodium picosulfate (NaP) or diatrizoate (gastrografin) seem most effective, but potentially have more side effects than PEG. Future research is needed for more patient friendly but effective preparations, especially for colon capsule and pan-intestinal capsule endoscopy.

The Bowel CLEANsing National Initiative: High-Volume Split-Dose Vs Low-Volume Split-Dose Polyethylene Glycol Preparations: A Randomized Controlled Trial

The aim of this study was to compare high-volume polyethylene glycol (PEG) with low-volume PEG with bisacodyl split-dosing regimens. Adult outpatients in 10 Canadian tertiary hospitals were randomized, stratified by morning or afternoon colonoscopy, to high-volume split-dose PEG (2 L+ 2 L) (High-SD) or low volume (1 L+ 1 L)+ bisacodyl (15 mg) PEG (Low-SD), with a second randomization to liquid or low-residue diets. The primary end point, using noninferiority hypothesis testing, was adequate bowel cleansing (Boston Bowel Preparation Scale total score of ≥6, with each of 3 colonic segments subscores ≥2). Secondary objectives were willingness to repeat the preparation, withdrawal time, cecal intubation, and polyp detection rates. Over 29 months, 2314 subjects were randomized to High-SD (N= 1157) or Low-SD (N= 1157) (mean age, 56.2 ± 13.4 y; 52.1% women). Colonoscopy indications were 38.2% diagnostic, 36.8% screening, and 25.0% surveillance, with no between-group imbalances in patient characteristics. Low-SD satisfied noninferiority criteria vs High-SD for adequate bowel cleanliness with only marginally inferior results (90.1% vs 88.1%; P= .02; difference, 2.0%; 95% CI [0.0%; 4.5%]). High-SD was associated with lower willingness to repeat (66.9% vs 91.9%; P < .01), was less well tolerated (7.3 ± 2.3 vs 8.1 ± 1.9; P < .01), causing more symptoms. No differences in procedural outcomes were noted except for more frequent cecal intubation rates after High-SD (97.4% vs 95.6%; P= .02). Among the High-SD group, adequate bowel preparation was greater after a clear liquid diet (93.6% vs 87.9%; P < .01), a finding not seen in the Low-SD group. Low-SD is noninferior to High-SD in providing adequate bowel preparation. Low-SD results in fewer symptoms, with greater willingness to repeat and tolerability. The overall impact of diet was modest.The study was approved by the research ethic boards from all sites and was registered at ClinicalTrials.gov (NCT02547571).

Routine GI Endoscopy

Background and Aim: Post-marketing studies comparing low-volume polyethylene glycol (PEG)-based regimens are limited. The aim of this randomized controlled non-inferiority study was to compare the efficacy and tolerability of two commercially available low-volume PEG-based preparations: PLENVU (Norgine) macrogol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride and Prepkit-C (Fresenius Kabi) macrogol 3350, sodium chloride, potassium chloride and sodium sulfate, sodium picosulfate, magnesium oxide, citric acid and aspartame in an unselected adult colonoscopy outpatient population. Methods: Patients undergoing outpatient colonoscopy were randomized to receive either split-dose Prepkit-C or PLENVU. Patient compliance, satisfaction, and tolerability were captured using a standardized questionnaire on the day of the procedure. A blinded endoscopist assessed the quality of bowel preparation using the Boston Bowel Preparation Scale (BBPS) and Aronchick Scale during the colonoscopy. The procedure times, rates of cecal intubation, and polyp detection rates were also recorded. Results: The study was terminated at 19 months, as recruitment was halted due to the coronavirus disease 2019 pandemic, and an unplanned interim analysis was performed. A total of 164 patients were randomly assigned to either Prepkit-C (n = 82) or PLENVU (n = 82). In the PLENVU group, 89% of patients achieved satisfactory preparation (total BPPS score ≥6 and each subscore ≥2), compared with 85.4% in the Prepkit-C group, resulting in an estimated difference of 3.7% (95% CI, -6.6% to 13.9%;P = 0.48). The median BBPS score with PLENVU was significantly better in the right, middle, and left colonic subsegments with PLENVU (BBPS score, 3;IQR, 2-3) than with Prepkit-C (BBPS score, 2;IQR, 2-3) (P < 0.001). A significantly higher proportion of patients in the PLENVU group had a BBPS score of ≥7, compared with patients in the Prepkit-C group (80% vs 57%;P = 0.002). A significantly greater proportion of patients had good-excellent quality of bowel preparation in the PLENVU group compared with the Prepkit-C group (84% vs 57%;P < 0.001) (Fig. 1). More patients in the PLENVU group reported moderate to severe nausea compared with those in the Prepkit-C group (P = 0.028);however, there were no other differences in patient satisfaction or tolerability between the two groups. Conclusion: The quality of bowel preparation achieved with PLENVU is at least non-inferior to that with Prepkit-C in a real-world unselected group of colonoscopy outpatients, with equivalent tolerability outcomes. This is despite a lower volume of preparation (by 500 mL) that is required to be ingested with PLENVU. Further studies are required in patients at risk of suboptimal bowel preparation.

Safety of low-volume PEG-asc bowel cleansing preparation for colonoscopy: identifying patients at risk for hypokalemia in a prospective cohort study.

Background and study aims The aim of bowel cleansing preparation should be high-quality results and conformance with safety standards. Previously, we reported that hypokalemia occurred in 23.6 % of patients after bowel preparation in a high-risk population on diuretics or hospitalized and referred for colonoscopy. Here we report on a prospective study in a non-selected colonoscopy cohort to identify patients at risk of developing hypokalemia before and after bowel cleansing with low-volume polyethylene glycol with ascorbic acid (PEG-asc). Patients and methods From January 1 to July 31, 2016, we included all patients undergoing colonoscopy in our institution. Prevalences of hypokalemia before and after PEG-asc bowel cleansing for colonoscopy were calculated and risk factors for developing hypokalemia after PEG-asc bowel cleansing were identified. Results In total, 2011 patients were included in the analysis. Of these, 0.8 % had hypokalemia before bowel cleansing with PEG-asc. After bowel preparation, 5.4 % developed hypokalemia. Of the patients, 281 were considered to have “high cardiac risk.” The combination of “high cardiac risk” and hypokalemia was present in 1 % of the initial colonoscopy population. Female sex, colorectal cancer diagnosis, and thiazide use were found to be significant predictors for hypokalemia after use of PEG-asc. No arrhythmias or serious adverse events due to hypokalemia occurred. Conclusions Physicians referring patients for colonoscopy should be aware that “high cardiac risk” patients and those on thiazide diuretics undergoing bowel cleansing for colonoscopy are a risk of developing post-cleansing hypokalemia but it remains to be determined whether their risk of developing life-threatening arrhythmias is truly increased.