The Bowel CLEANsing National Initiative: A Low-Volume Same-Day Polyethylene Glycol (PEG) Preparation vs Low-Volume Split-Dose PEG With Bisacodyl or High-Volume Split-Dose PEG Preparations-A Randomized Controlled Trial.

INTRODUCTION: Bowel cleanliness has been shown to be superior with split-dose vs nonsplit preparations; we aimed to directly assess the poorly characterized comparative efficacies of split-dose vs same-day polyethylene glycol (PEG) regimens. METHODS: In this study, one of a series of randomized trials performed across 10 Canadian endoscopy units, patients undergoing colonoscopies between 10:30 and 16:30 were allocated to PEG low-volume same-day (15 mg bisacodyl the day before, 2 L the morning of the procedure), low-volume split-dose (15 mg bisacodyl the day before, 1 L + 1 L), or high-volume split-dose (2 L + 2 L). Coprimary endpoints were adequate bowel cleansing based on the Boston Bowel Preparation Scale using in turn different threshold cutoffs. RESULTS: Overall, 1,750 subjects were randomized equally across the 3 groups, with no differences in adequate bowel cleanliness rates (low-volume same-day, 90.5%; high-volume split-dose, 92.2%; P = 0.34; and low-volume split-dose, 87.9%; P = 0.17) for the Boston Bowel Preparation Scale ≥6 and 2 for each segment. Willingness to repeat the preparation was not significantly different between low-volume same-day (91.0%) and low-volume split-dose (92.5%; P = 0.40) but was greater than the high-volume split-dose (68.9%; P < 0.01). No significant differences were noted for withdrawal time, cecal intubation, or polyp detection rates. DISCUSSION: In this large randomized trial of PEG regimens, low-volume same-day resulted in similar bowel cleanliness compared with high-volume or low-volume split-dosing. Willingness to repeat and tolerability were superior with low-volume same-day compared with high-volume split-dose and similar to low-volume split-dose.

Efficacy of 1-day vs. 2-day intestinal preparation using peg 3350 + Bisacodyl: A randomized clinical trial. / Eficacia de la preparación intestinal con un día de PEG 3350 + bisacodilo en comparación con dos días: ensayo clínico aleatorizado.

OBJECTIVE: The objective was to compare the efficacy of 1-day intestinal preparation for colonoscopy using PEG 3350 (polyethylene glycol) (4 g/kg/day) + bisacodyl vs. 2-day intestinal preparation using PEG 3350 (2 g/kg/day) + bisacodyl in pediatric patients. MATERIALS AND METHODS: A blind, randomized clinical trial was carried out with endoscopists who assessed colon cleansing. Patients aged 2-18 years old undergoing scheduled colonoscopy were included. They were randomized into 2 groups: 1-day preparation using PEG 3350 (4 g/kg/day) + bisacodyl, and 2-day preparation using PEG 3350 (2 g/kg/day) + bisacodyl. Endoscopic evaluation (Boston Scale) allowed the efficacy of both preparations to be assessed. Statistical analysis: T of Student for quantitative variables, and Chi square for qualitative variables. RESULTS: 72 patients with a mean age of 94 ± 49 months were included. No significant difference was found between groups regarding preparation difficulty and safety. Efficacy, assessed using the Boston Scale score and the proportion of excellent and good grades achieved, was higher in the 1-day group. Left colon score and total score were higher than in the 2-day group (left colon: 2.20 vs. 1.89, p=0.03; total score: 7.28 vs. 6.76, p=0.01) (left colon: 94.4% vs. 83.4%, p=0.034). CONCLUSIONS: Efficacy in the quality of intestinal preparation for colonoscopy was higher in the 1-day group using PEG 3350 + oral bisacodyl than in the 2-day group.

OBEJTIVO: Comparar la eficacia de la preparación intestinal para colonoscopia con 1 día de preparación con PEG 3350 (polietilenglicol) (4 g/kg/día) + bisacodilo en comparación con 2 días de preparación con PEG 3350 (2 g/kg/día) + bisacodilo en pacientes pediátricos. MATERIAL Y METODOS: Se realizó un ensayo clínico, aleatorizado y cegado para los médicos endoscopistas que evaluaron la limpieza del colon. Se incluyeron pacientes de 2 a 18 años, que ameritaban colonoscopia en forma programada. Se aleatorizaron a los pacientes en dos grupos: 1 día de preparación con PEG 3350 (4 g/kg/día) + bisacodilo y 2 días de preparación con PEG 3350 (2 g/kg/día) + bisacodilo. Por medio de valoración endoscópica (escala de Boston) se determinó la eficacia de las dos preparaciones a evaluar. Análisis estadístico: T de student para cuantitativas y Chi2 para cualitativas. RESULTADOS: Se incluyeron 72 pacientes con edad promedio de 94 ± 49 meses. No hubo diferencia significativa entre los grupos con respecto a la dificultad y seguridad de la preparación. La eficacia, evaluada por el puntaje de la escala de Boston y la proporción de calificación excelente o buena, fue mejor en el grupo de un 1 día, el colon izquierdo y el puntaje total fue mejor en comparación al grupo de 2 días (colon izquierdo 2,20 vs. 1,89 p= 0,03 y total 7,28 vs. 6,76 p= 0,01) (colon izquierdo 94,4 vs. 83,4% p= 0,034). CONCLUSIONES: La eficacia de la calidad en la preparación intestinal para colonoscopia fue mejor entre el grupo de 1 día con PEG 3350 + bisacodilo vía oral en comparación a la preparación de 2 días.

Eficacia de la preparación intestinal con un día de PEG 3350 + bisacodilo en comparación con dos días: ensayo clínico aleatorizado / Efficacy of 1-day vs. 2-day intestinal preparation using peg 3350 + bisacodyl: A randomized clinical trial

Objetivo: Comparar la eficacia de la preparación intestinal para colonoscopia con 1 día de preparación con PEG 3350 (polietilenglicol) (4 g/kg/día) + bisacodilo en comparación con 2 días de preparación con PEG 3350 (2 g/kg/día) + bisacodilo en pacientes pediátricos. Material y métodos: Se realizó un ensayo clínico, aleatorizado y cegado para los médicos endoscopistas que evaluaron la limpieza del colon. Se incluyeron pacientes de 2 a 18 años, que ameritaban colonoscopia en forma programada. Se aleatorizaron a los pacientes en dos grupos: 1 día de preparación con PEG 3350 (4 g/kg/día) + bisacodilo y 2 días de preparación con PEG 3350 (2 g/kg/día) + bisacodilo. Por medio de valoración endoscópica (escala de Boston) se determinó la eficacia de las dos preparaciones a evaluar. Análisis estadístico: T de student para cuantitativas y Chi2 para cualitativas. Resultados: Se incluyeron 72 pacientes con edad promedio de 94 ± 49 meses. No hubo diferencia significativa entre los grupos con respecto a la dificultad y seguridad de la preparación. La eficacia, evaluada por el puntaje de la escala de Boston y la proporción de calificación excelente o buena, fue mejor en el grupo de un 1 día, el colon izquierdo y el puntaje total fue mejor en comparación al grupo de 2 días (colon izquierdo 2,20 vs. 1,89 p = 0,03 y total 7,28 vs. 6,76 p = 0,01) (colon izquierdo 94,4 vs. 83,4% p = 0,034). Conclusiones: La eficacia de la calidad en la preparación intestinal para colonoscopia fue mejor entre el grupo de 1 día con PEG 3350 + bisacodilo vía oral en comparación a la preparación de 2 días

Objective: The objective was to compare the efficacy of 1-day intestinal preparation for colonoscopy using PEG 3350 (polyethylene glycol) (4 g/kg/day) + bisacodyl vs. 2-day intestinal preparation using PEG 3350 (2 g/kg/day) + bisacodyl in pediatric patients. Materials and methods: A blind, randomized clinical trial was car-ried out with endoscopists who assessed colon cleansing. Patients aged 2-18 years old undergoing scheduled colonoscopy were included. They were randomized into 2 groups: 1-day preparation using PEG 3350 (4 g/kg/day) + bisacodyl, and 2-day preparation using PEG 3350 (2 g/kg/day) + bisacodyl. Endoscopic evaluation (Boston Scale) allowed the efficacy of both preparations to be assessed. Statistical analysis: T of Student for quantitative variables, and Chi square for qualitative variables. Results: 72 patients with a mean age of 94 ± 49 months were included. No significant difference was found between groups regarding preparation difficulty and safety. Efficacy, assessed using the Boston Scale score and the proportion of excellent and good grades achieved, was higher in the 1-day group. Left colon score and total score were higher than in the 2-day group (left colon: 2.20 vs. 1.89, p = 0.03; total score: 7.28 vs. 6.76, p = 0.01) (left colon: 94.4% vs. 83.4%, p = 0.034). Conclusions: Efficacy in the quality of intestinal preparation for colonoscopy was higher in the 1-day group using PEG 3350 + oral bisacodyl than in the 2-day group

A Randomized Trial Comparing the Bowel Cleansing Efficacy of Sodium Picosulfate/Magnesium Citrate and Polyethylene Glycol/Bisacodyl (The Bowklean Study).

Bowel cleansing is essential for a successful colonoscopy, but the ideal clearing agent and the volume have yet to be determined. A small-volume cleanser is important for patient compliance. This study aimed to compare the bowel cleansing efficacy, safety, tolerability, and acceptability of a 300-mL small-volume sodium picosulfate/magnesium citrate (PSMC) preparation-Bowklean with one 2-L polyethylene glycol (PEG)/bisacodyl-Klean-Prep/Dulcolax preparation under identical dietary recommendations. This multicenter, randomized, parallel-group, pre-specified noninferiority study enrolled 631 outpatients scheduled to undergo colonoscopy (Bowklean = 316 and Klean-Prep/Dulcolax = 315). After bowel preparation, an independent evaluator blinded to the subject's treatment allocation rated the quality of the colon cleansing. Efficacy was evaluated using the Aronchick Scale and Ottawa Bowel Preparation Scale (OPBS). Safety was assessed by monitoring adverse events. Tolerability and acceptability were measured via a patient questionnaire. Bowklean was non-interior to Klean-Prep/Dulcolax in overall colon cleansing but was associated with significantly better preparation quality. Notably, Bowklean was associated with significantly greater tolerability and acceptability of bowel preparations than Klean-Prep/Dulcolax. Safety profiles did not differ significantly between the groups. Our data indicate that Bowklean is a more effective and better-tolerated bowel cleansing preparation before colonoscopy than Klean-Prep/Dulcolax. Bowklean may therefore increase positive attitudes toward colonoscopies and participation rates.

Combination of bisacodyl suppository and 1 L polyethylene glycol plus ascorbic acid is a non-inferior and comfortable regimen compared to 2 L polyethylene glycol plus ascorbic acid.

BACKGROUND AND AIM: Appropriate bowel cleansing before colonoscopy is an important factor in increasing the detection rate of lesions. Low-volume polyethylene glycol (PEG) plus ascorbic acid (PEG-Asc) reduces the dosage of bowel preparation agent, but still presents discomfort to patients. The primary aim of the present study was to compare the efficacy of bowel cleansing between 2 L PEG-Asc (control) and 1 L PEG-Asc with bisacodyl suppository (suppository) groups, and the secondary aim was to investigate complications and tolerability between the two groups. METHODS: This was a single-center prospective randomized controlled study. We identified 168 patients scheduled for colonoscopy between August 2017 and January 2018 and randomly assigned them to the control or to the suppository groups. Efficacy of bowel cleansing was assessed using the Boston Bowel Preparation Scale (BBPS), and side-effects were surveyed using questionnaires. RESULTS: No significant difference was detected in baseline characteristics including insertion and withdrawal times, and adenoma detection rates between the two groups. Total BBPS score was 7.93 ± 1.06 and 7.74 ± 1.02 in the control and suppository groups, respectively (P = 0.22). Incidence of abdominal pain and nausea was not statistically different, whereas that of sleep disturbance and anal discomfort was higher in the control group. (P = 0.00). CONCLUSIONS: One liter PEG-Asc with bisacodyl suppository resulted in an equivalent bowel-cleansing outcome with reduced patient discomfort compared to 2 L PEG-Asc. Therefore, PEG-Asc with bisacodyl suppository represents a potential alternative and increases patient compliance with bowel preparation.

Multicentre endoscopist-blinded randomised clinical trial to compare two bowel preparations after a colonoscopy with inadequate cleansing: a study protocol.

INTRODUCTION: Inadequate bowel preparation is common and negatively impacts colonoscopy quality. The objective of this study is to compare two bowel preparation regimens in cleansing the colon after an index colonoscopy with failed bowel preparation. METHODS AND ANALYSIS: This is a phase III, multicentre, randomised clinical trial comparing two bowel preparation regimens after failure to adequately cleanse at the index colonoscopy. Regimen A consists of 4 L split-dose polyethylene glycol electrolyte solution (PEG-ELS) and Regimen B consists of 6 L split-dose PEG-ELS, both preceded by 15 mg of bisacodyl the day before the procedure along with a low-fibre diet 3 and 2 days before the procedure followed by a clear fluid diet starting the day before the procedure. The primary outcome is adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score of ≥6 with each segment score ≥2. Secondary outcomes include mean BBPS score, bowel preparation adequacy using the US Multi-Society Task Force on Colorectal Cancer definition, detection rate by polyp subtype, caecal intubation rate, mean Validated Patient Tolerability Questionnaire for Bowel Preparation score, subject willingness to repeat the preparation and faecal incontinence rate. ETHICS AND DISSEMINATION: The study will be conducted in accordance with Good Clinical Practice guidelines and local institutional standards. Study findings will be disseminated at an international gastroenterology conference and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02976805; Pre-results.

Comparison of asymmetric (low morning-dose) and standard split-dose regimen of PEG plus bisacodyl for bowel preparation: A randomized controlled trial.

BACKGROUND: Reducing the morning dose of PEG solution may be a reliable strategy to improve the patient compliance of split-dose regimens without affecting efficacy of bowel cleansing. AIMS: to compare the efficacy for bowel cleansing of an asymmetric split-dose regimen (25% of the dose on the day of colonoscopy and 75% on the day before) with the standard split-dose regimen. METHODS: Outpatients were enrolled in a randomized, single-blind, non-inferiority clinical trial. All subjects received a split-dose preparation with a 2L PEG-citrate-simethicone plus Bisacodyl. Patients were randomly assigned to: group A, asymmetric split-dose regimen; group B, symmetric split-dose regimen. Primary endpoint was the proportion of adequate bowel cleansing. RESULTS: Split-dose was taken by 81 and 80 patients in group A and B. Adequate bowel cleansing was achieved in 92.6% and 92.5% patients in group A and B (p = 1.000). No differences were observed regarding Boston Bowel Preparation Scale total score, adenoma detection rate and scores of each colon segment. CONCLUSIONS: The reduction of morning dose of PEG in a split-dose regimen is not inferior to the standard split-dose regimen in achieving an adequate bowel cleansing. However, further studies are needed to evaluate whether asymmetric preparation is associated to a higher tolerability compared to symmetric split-dose regimen. (NCT03146052).

A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a feasibility study.

BACKGROUND: The importance of high quality preprocedural bowel preparation is widely acknowledged, but suboptimal bowel cleansing still occurs in up to 20 % of all colonoscopy patients. The aim of this study was to evaluate the performance of a novel intraprocedural cleaning device for cleaning poorly prepared colons. METHODS: This multicenter feasibility study included patients aged 18 - 75 years who were referred for colonoscopy. Intraprocedural cleaning was performed in patients after a limited preprocedural bowel preparation regimen (2 days of dietary restrictions and 2 × 10 mg bisacodyl). The primary outcome was the proportion of adequately prepared patients (Boston Bowel Preparation scale [BBPS] ≥ 2 in each segment) before and after segmental washing with the new device. Secondary outcomes included: cecal intubation rate, procedure time, system usability, patient satisfaction, and safety. RESULTS: 47 patients (42.6 % male), with a median age of 61 years (interquartile range [IQR] 46 - 67 years), were included at three clinical sites. Cecal intubation was achieved in 46/47 patients (97.9 %). The cleaning device significantly improved the proportion of patients with adequate bowel cleansing (from 19.1 % to 97.9 %; P < 0.001) and median BBPS score (from 3.0 [IQR 0.0 - 5.0] to 9.0 [IQR 8.0 - 9.0]). Median cecal intubation time and total procedure time were 16.5 minutes (IQR 9.0-28.3) and 34.0 minutes (IQR 25.0 - 42.8), respectively. Physicians were satisfied with the ease of use of the device and it was well tolerated by patients. No severe adverse events occurred during the study period. CONCLUSIONS: This feasibility study suggests that the intraprocedural cleaning device appears to be safe and effective in cleaning poorly prepared colons to an adequate level, allowing a thorough colorectal examination.

Comparative safety of bowel cleansers: protocol for a systematic review and network meta-analysis.

INTRODUCTION: The US Food and Drug Administration has withdrawn the bowel cleansing kit HalfLytely (PEG 3500) with 10 mg bisacodyl tablets due to an increased risk of ischaemic colitis compared with the same kit with only 5 mg bisacodyl. This is of interest in Canada given that the bowel cleansing kit Bi-Peglyte (PEG 3500) with 15 mg bisacodyl is currently approved for use. The objective is to assess the comparative safety of various bowel cleansers with or without bisacodyl, with a primary interest inpolyethylene glycol (PEG)-based and sodium-picosulfate-based products. METHODS AND ANALYSIS: Given the existing volume of the literature, the review will be conducted in two stages. Stage 1 will consist of a scoping exercise by searching MEDLINE, Embase and the Cochrane Library (up to 21 November 2017) to identify randomised controlled trials, quasirandomised studies and non-randomised studies in which any bowel cleanser regimens were compared among persons undergoing colonoscopy. The outcomes will be mapped to establish a listing of the studies and their comparisons and outcomes currently available in the literature. From this, a data synthesis plan will be determined. In stage 2, a systematic review with meta-analyses will be pursued, focused on the bowel cleanser comparisons and outcomes of interest identified in stage 1. Two reviewers will screen, extract and quality assess the articles. Outcomes of interest include ischaemic colitis, electrolyte imbalances and their consequences, seizures, bowel perforation and patient tolerability. If sufficient data exist and studies are of sufficient homogeneity, network meta-analyses (NMAs) will be performed. ETHICS AND DISSEMINATION: Ethics approval was not necessary due to study design. Updating the safety profile of bowel cleansers among the generally healthy population undergoing colonoscopy is pertinent given recent approval changes. This will be the first NMA within this population. Policy considerations may be reconsidered to minimise risk during bowel cleanser use. PROSPERO REGISTRATION NUMBER: CRD42018084720.

Split-dose bowel cleansing with picosulphate is safe and better tolerated than 2-l polyethylene glycol solution.

BACKGROUND: In physically less fit patients and patients requiring repeated exams, adequate bowel preparation for colonoscopy remains problematic, particularly because patients need to drink large volumes of unpleasant-tasting fluids. A further concern is potential unwarranted fluid shifts. AIMS: This study aimed to compare the safety and burden of a small-volume sodium picosulphate/magnesium citrate preparation (SPS-MC) with a 2-l ascorbic-acid-enriched polyethylene glycol solution plus bisacodyl pretreatment (PEG-Asc+B). PATIENTS AND METHODS: Patients referred for colonoscopy were randomized to SPS-MC or PEG-Asc+B administered as a split-dose regimen. Patients received advice on the recommended 4-l SPS-MC and 2-l PEG-Asc+B fluid intake. Safety was assessed by blood sampling before and after the preparation and during a 30-day follow-up period. A questionnaire assessed tolerability and perceived burden of the preparation. RESULTS: A total of 341 patients underwent colonoscopy. Blood sampling showed a slight but significant decrease in sodium, chloride and osmolality and increase in magnesium in the SPS-MC group and a decrease in bicarbonate in the PEG-Asc+B group. Hyponatraemia and hypermagnesaemia without clinical signs were observed in 16 (14 SPS-MC) and 13 SPS-MC patients, respectively. Patients reported significantly fewer physical complaints and a significantly higher completion rate with SPS-MC. Patients receiving SPS-MC rated the intake as being easier and better tasting. In the event of a repeat colonoscopy, 59.7% of patients in the PEG-Asc+B and 93.6% of patients in the SPS-MC group would opt for the same preparation again. CONCLUSION: Despite electrolyte shifts, both SPS-MC and PEG-Asc+B appeared clinically safe. From a patient's perspective, a small-volume preparation formula such as SPS-MC is preferred, resulting in fewer physical complaints and greater ease of intake.

Polyethylene Glycol-3350 (Miralax®)+1.9-L sports drink (Gatorade®)+2 tablets of bisacodyl results in inferior bowel preparation for colonoscopy compared with Polyethylene Glycol-Ascorbic Acid (MoviPrep®).

BACKGROUND/AIMS: Polyethylene glycol (PEG)-3350, approved by Food and Drug Administration (FDA) only for constipation, combined with 1.9 L of sports drink (SD) (GatoradeR) and bisacodyl (B) is commonly used in outpatient practice for bowel preparation due to cited patient satisfaction and tolerability of this specific regimen. We aim to compare PEG-3350 (MiralaxR) with PEG-AA-based (MoviPrepR) in terms of efficacy, patient satisfaction, and the effects of these two regimen on serum electrolytes. MATERIALS AND METHODS: This study is a prospective, single-blinded, block randomized trial comparing single-dose PEG-3350+SD+B to split-dose 2-L PEG-AA in the outpatient endoscopy unit in patients undergoing colonoscopy. Basic metabolic profiles were checked on the day of randomization and on the day of procedure. Patients completed a survey on the day of procedure. Bowel preparation quality was assessed using the Boston Bowel Preparation Scale (BBPS) by two endoscopists and a nurse present during the procedure. RESULTS: We randomized 150 patients (74 PEG-3350+SD+B and 76 PEG-AA). The PEG-AA group had significantly higher BBPS scores in the right colon by Endoscopist 1, Nurse, and Endoscopist 2 (p 0.005, <0.000, 0.001) and in the left and transverse colon by Nurse and Endoscopist 2 (p 0.004, 0.26, 0.000, 0.006). There was no statistically significant difference in patient satisfaction or change in serum electrolytes between the two groups. CONCLUSION: Use of single-dose PEG-3350+SD+B results in inferior bowel preparation for colonoscopy compared with split-dose PEGAA and does not provide any advantage in regards to patient satisfaction. We therefore recommend discontinuing the use of PEG 3350 for bowel preparation.

Efficacy and Safety of Sodium Picosulfate/Magnesium Citrate for Bowel Preparation in a Physically Disabled Outpatient Population: A Randomized, Endoscopist-Blinded Comparison With Ascorbic Acid-Enriched Polyethylene Glycol Solution Plus Bisacodyl (The PICO-MOVI Study).

BACKGROUND: Because of its volume, adequate bowel preparation remains problematic in physically unfit patients. OBJECTIVE: This study aimed to compare a small-volume sodium picosulfate/magnesium citrate preparation with a 2-L ascorbic acid-enriched polyethylene glycol solution plus bisacodyl. DESIGN: This study has a noninferiority design, assuming that ascorbic acid-enriched polyethylene glycol solution plus bisacodyl is 70% efficacious in achieving an Ottawa score ≤7 and accepting a difference in success rate of <15% with a target enrollment of 146 patients per group. SETTING: This study was conducted in an outpatient department. PATIENTS: Patients referred for diagnostic colonoscopy were randomly assigned. Key exclusion criteria were severe kidney disease, ASA class ≥III, and hospital admission. INTERVENTION: Patients were randomly assigned to receive sodium picosulfate/magnesium citrate or ascorbic acid-enriched polyethylene glycol solution plus bisacodyl according to a split-dose regimen. Patients in the sodium picosulfate/magnesium citrate group received advice on the recommended 4-L fluid intake. Patients in the ascorbic acid-enriched polyethylene glycol solution plus bisacodyl group received 2 bisacodyl tablets 2 days before and advice on the additionally recommended 2-L fluid intake. MAIN OUTCOME MEASURES: To assess bowel-cleansing adequacy, the Ottawa, Aronchick, and Boston scores were used. Colonoscopy quality measures were obtained. Safety was assessed for a 30-day follow-up period. RESULTS: Overall, 341 patients (169 men, mean age 57.0 years; BMI 26.2 kg/m) were included. Comorbidities were present in 76.2% of patients, and 75.4% of patients used medication. An adequate Ottawa score was obtained in 81.4% and 75.8% of patients receiving ascorbic acid-enriched polyethylene glycol solution plus bisacodyl and sodium picosulfate/magnesium citrate (difference of 5.6% (95% CI, -3.5 to -14.6; p = 0.023)), showing noninferiority of the sodium picosulfate/magnesium citrate therapy. Ottawa segmental scores were lower for sodium picosulfate/magnesium citrate in the right and transverse colon. In both groups, successful ileocecal intubation was achieved in 95%. No medication-related adverse events were reported. LIMITATIONS: These results in a physically disabled ambulant population cannot be extrapolated to immobile, hospitalized patients. CONCLUSIONS: Sodium picosulfate/magnesium citrate proved to be noninferior to ascorbic acid-enriched polyethylene glycol solution plus bisacodyl in efficacy and safety. Timing of the colonoscopy and addition of bisacodyl to sodium picosulfate/magnesium citrate warrants further consideration. See Video Abstract at http://links.lww.com/DCR/A461.

Same-day Versus Split-dose Bowel Preparation Before Colonoscopy: A Meta-analysis.

BACKGROUND: Split-dose regimens (SpDs) were recommended as a first choice for bowel preparation, whereas same-day regimens (SaDs) were recommended as an alternative; however, randomized trials compared them with mixed results. The meta-analysis was aimed at clarifying efficacy level between the 2 regimens. MATERIALS AND METHODS: We used MEDLINE/PubMed, EMBASE, Scopus, CINAHL, Cochrane Library, and Web of Science to identify randomized trials published from 1990 to 2016, comparing SaDs to SpDs in adults. The pooled odds ratios (ORs) were calculated for preparation quality, cecal intubation rate (CIR), adenoma detection rate (ADR), and any other adverse effects. RESULTS: Fourteen trials were included. The proportion of individuals receiving SaDs and SpDs with adequate preparation in the pooled analysis were 79.4% and 81.7%, respectively, with no significant difference [OR=0.92; 95% confidence interval (CI), 0.62-1.36] in 11 trials. Subgroup analysis revealed that the odds of adequate preparation for SaDs with bisacodyl were 2.45 times that for SpDs without bisacodyl (95% CI, 1.45-4.51, in favor of SaDs with bisacodyl). Subjects received SaDs experienced better sleep. CONCLUSIONS: SaDs were comparable with SpDs in terms of bowel cleanliness, CIR, and ADR, and could also outperform SpDs in preparation quality with bisacodyl. SaDs also offered better sleep the previous night than SpDs did, which suggests that SaDs might serve as a superior alternative to SpDs. The heterogenous regimens and measurements likely account for the low rates of optimal bowl preparations in both arms. Further studies are needed to validate these results and determine the optimal purgatives and dosages.

Tolerancia, seguridad y eficacia de la preparación intestinal con un día de PEG3350 + bisacodilo en comparación con 2 días de PEG3350 + bisacodilo en pacientes pediátricos / Tolerance, safety and efficacy of the one-day preparation of PEG3350 + bisacodyl compared to 2 days of PEG3350 + bisacodyl in pediatric patients

Resumen: Introducción: Múltiples preparaciones intestinales se han utilizado en niños sometidos a una colonoscopia, con limitación variable debido a la aceptación, tolerancia y la limpieza adecuada. El objetivo del estudio fue comparar la tolerancia seguridad y eficacia de la preparación intestinal para colonoscopia de 1 día con PEG 3350 (polietilenglicol) (4 g/kg/día) + bisacodilo y el tratamiento con 2 días de preparación con PEG 3350 (2 g/kg/día) + bisacodilo en pacientes pediátricos. Métodos: Se realizó un ensayo clínico, aleatorizado y ciego. Se incluyeron pacientes de 2 a 18 años, que ameritaron colonoscopia en forma programada. Los pacientes se asignaron de manera aleatoria en dos grupos: 1 día de preparación con PEG 3350 4 g/kg/día + bisacodilo y 2 días de preparación con PEG 3350 2 g/kg/día + bisacodilo. Por medio de un cuestionario, exploración física y valoración endoscópica (escala de Boston), se determinó la tolerancia, seguridad y eficacia de las 2 preparaciones a evaluar. Se realizó una prueba t de Student para variables cuantitativas y χ2 para variables cualitativas. Resultados: No hubo diferencias significativas en las tasas de cumplimiento, los efectos adversos y la extensión de la evaluación colonoscópica. Conclusiones: La tolerancia y seguridad entre la preparación intestinal para colonoscopia de 1 día con PEG 3350 (polietilenglicol) (4 g/kg/día) + bisacodilo y la preparación de 2 días con PEG 3350 (2 g/kg/día) + bisacodilo fue semejante. La calidad de la limpieza fue buena en ambos grupos, siendo parcialmente más eficaz en el grupo de 1 día con PEG 3350 (polietilenglicol) (4 g/kg/día).

Abstract: Background: Multiple intestinal preparations have been used in children undergoing colonoscopy, with variable limitation due to acceptance, tolerance, and proper cleaning. The objective of this study was to compare the tolerability, safety and efficacy of the colonoscopy preparation with 1 day with PEG 3350 (poliethylenglycol) (4 g/kg/day) + bisacodyl compared to 2 days of preparation with PEG 3350 (2 g/kg/day) + bisacodyl in pediatric patients. Methods: A clinical, randomized, and blind trial was performed. Patients aged 2 to 18 years scheduled for colonoscopy were included. Patients were randomized into two groups: 1 day of preparation with PEG 3350 4 g/kg/day + bisacodyl and 2 days of preparation with PEG 3350 2 g/kg/day + bisacodyl. Through a questionnaire, physical examination and endoscopic evaluation (Boston scale), the tolerance, safety and efficacy of the 2 preparations to be evaluated were determined. Student's t test was performed for quantitative variables and χ2 for qualitative variables. Results: There were no significant differences in compliance rates, adverse effects, and extent of colonoscopic evaluation. Conclusions: Tolerance and safety between the intestinal preparation for 1-day colonoscopy with PEG 3350 (4 g/kg/day) + bisacodyl and the 2-day preparation with PEG 3350 (2 g/kg/day) + bisacodyl were similar. The quality of cleanliness was good in both groups, being partially more effective in the 1-day group with PEG 3350 (4 g/kg/day).

Colon-targeted delivery of solubilized bisacodyl by doubly enteric-coated multiple-unit tablet.

A doubly enteric-coated multiple-unit tablet (DET) of bisacodyl (BD) was formulated to selectively deliver the stimulant laxative to the large intestine. Solubilized BD in surfactants was adsorbed into the porous carrier and primarily coated with different combinations of pH-sensitive polymers (Eudragit S and Eudragit L) and time-dependent release polymer (Eudragit RS). BD-loaded granules were compressed into tablets and coated again with pH-sensitive polymers (Eudragit S:Eudragit L=1:1). The multiple-unit tablet was optimized with respect to the granular coating compositions (Eudragit S:Eudragit L:Eudragit RS=5:1:4) and coating level (12.5%), and coating level on the tablet (25%), by evaluating in vitro release profile in continuous dissolution medium. Drug release from the optimized tablet was effectively retarded in the simulated gastric and small intestinal fluids (below 7%), but profound drug liberation was attained in the colonic fluid (over 50%). On the other hand, drug release from the marketed product (Dulcolax®, Boehringer Ingelheim Pharma), a reference drug, in the gastric and small intestinal fluids was reached to 30%, while that in the colonic fluid was only 7%. In an in vivo efficacy study in loperamide-induced constipated rabbits, a remarkable recovery in fecal secretion was observed in the DET-treated group 24h post-dosing, compared to vehicle-treated (p<0.05) and the marketed product-treated groups (p<0.05). Moreover, pharmacokinetic evaluation in the constipated rabbits revealed that the DET system significantly lowered the systemic exposure compared with the marketed product (p<0.05), by hindering drug release in the upper intestine, a preferential absorption site. Therefore, the novel colon-targeted delivery system may be an alternative for boosting pharmacological responses in the colon, while diminishing the intestinal irritation and/or systemic adverse effect of the stimulant laxative.

Comparison of Two Intensive Bowel Cleansing Regimens in Patients With Previous Poor Bowel Preparation: A Randomized Controlled Study.

OBJECTIVES: Inadequate bowel cleansing is a major burden for endoscopy units. The aim of this study was to compare two intensive bowel cleansing regimens in patients with previous colonoscopy with inadequate bowel preparation. METHODS: Patients with inadequate cleansing at index colonoscopy were randomized to 4-L split-dose polyethylene-glycol (PEG) regimen vs. 2-L split-dose PEG plus ascorbic acid (PEG+Asc) regimen. All individuals underwent a 3-day low-residue diet and received 10 mg of bisacodyl, the day before colonoscopy. Cleansing was considered to be adequate if the Boston Bowel Preparation Scale scored ≥2 at each colonic segment. A non-inferiority analysis was performed to demonstrate that colonic cleansing with 2-L PEG+Asc was not inferior to 4-l PEG, considering a non-inferiority margin of 10%. RESULTS: Adequate bowel cleansing was significantly higher in patients assigned to 4-L PEG regimen (n=127) vs. those randomized to 2-L PEG+Asc regimen (n=129) by intention-to-treat analysis (81.1 vs. 67.4%, odds ratio (OR) 2.07, 95% confidence interval (CI) (1.163-3.689)) and by per-protocol analysis (86.6 vs. 71.7%, OR: 2.55, 95% CI: (1.316-4.922)). The study was terminated for futility after the interim analysis, because the 95% CI of the difference of proportions was 3.13-24.27% in the intention-to-treat analysis and 3.33-26.47% in the per-protocol analysis, confirming the superiority of 4-L PEG preparation. CONCLUSIONS: After 3-day low-residue diet and oral bisacodyl before colonoscopy, colon cleansing with 4-L split-dose PEG was superior to 2-L split-dose PEG+Asc in patients with previous inadequate cleansing. (EUDRACT: 2013-002506-31, NCT02073552).

Randomized controlled trial: Standard versus supplemental bowel preparation in patients with Bristol stool form 1 and 2.

BACKGROUND: Bristol stool form 1 and 2 is an important predictor of inadequate bowel preparation. AIM: To evaluate the efficacy of supplemental preparation in bowel cleansing quality among patients with Bristol stool form 1 and 2, as well as the feasibility of tailored bowel preparation guided by Bristol stool form scale. METHODS: Patients with Bristol stool form 1 and 2 from 3 Chinese tertiary hospitals randomly received either 2 L PEG-ELP (group A) or 10 mg bisacodyl plus 2 L PEG-ELP (group B); patients with Bristol stool form 3 to 7 received 2 L PEG-ELP (group C) for bowel preparation. The primary endpoint is the rate of adequate bowel reparation for the whole colon. The adequate bowel preparation rate for separate colon segments, the polyp detection rate (PDR), tolerability, acceptability, sleeping quality and compliance were evaluated as secondary endpoints. RESULTS: 700 patients were randomized. In per-protocol analysis, patients in group B attained significantly higher successful preparation rate than group A (88.7% vs. 61.2%, p<0.001) and similar with group C (88.7% vs. 85.0%, p = 0.316). The PDR in group B was significantly higher than group A (43.2% vs. 25.7%, p<0.001). Acceptability was much higher in group B and C. CONCLUSIONS: 10 mg bisacodyl plus 2 L PEG-ELP can significantly improve both bowel preparation quality and PDR in patients with Bristol stool form 1 and 2. Bristol stool form scale may be an easy and efficient guide for tailored bowel preparation before colonoscopy.

Management of chronic constipation in patients with diabetes mellitus.

AIM: The aim of this review is to provide an overview of the clinical assessment and evidence-based treatment options for managing diabetes-associated chronic constipation. METHODS: A literature search of published medical reports in English language was performed using the OVID Portal, from PUBMED and the Cochrane Database of Systematic Reviews, from inception to October 2015. A total of 145 abstracts were identified; duplicate publications were removed and 95 relevant full-text articles were retrieved for potential inclusion. RESULTS: Chronic constipation is one of the most common gastrointestinal symptoms in patients with diabetes, and occurs more frequently than in healthy individuals. Treatment goals include improving symptoms and restoring bowel function by accelerating colonic transit and facilitating defecation. Based on guidelines and data from published literature, food and dietary change with exercise and lifestyle change should be the first step in management. For patients recalcitrant to these changes, laxatives should be the next step of treatment. Treatment should begin with bulking agents such as psyllium, bran or methylcellulose followed by osmotic laxatives if response is poor. Lactulose, polyethylene glycol and lactitol are the most frequently prescribed osmotic agents. Lactulose has a prebiotic effect and a carry-over effect (continued laxative effect for at least 6 to 7 days, post cessation of treatment). Stimulants such as bisacodyl, sodium picosulphate and senna are indicated if osmotic laxatives are not effective. Newer agents such as chloride-channel activators and 5-HT4 agonist can be considered for severe or resistant cases. CONCLUSION: The primary aim of intervention in diabetic patients with chronic constipation is to better manage the diabetes along with management of constipation. The physician should explain the rationale for prescribing laxatives and educate patients about the potential drawbacks of long-term use of laxatives. They should contact their physician if short-term use of prescribed laxative fails to provide relief.

Comparison of a split-dose bowel preparation with 2 liters of polyethylene glycol plus ascorbic acid and 1 liter of polyethylene glycol plus ascorbic acid and bisacodyl before colonoscopy.

BACKGROUND AND AIMS: Recently, a low-volume polyethylene glycol formulation containing ascorbic acid (PEG-Asc) has proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation. However, currently available aqueous purgative formulations are poorly tolerated. The aim of this study was to compare a split-dose 2-L PEG-Asc formulation and a 1-L PEG-Asc formulation with bisacodyl (10 mg) to determine the quality of bowel cleansing and patient tolerability. METHODS: A single-center, randomized, observer-blinded study was performed between May 2015 and September 2015. Two hundred outpatients referred for colonoscopy were prospectively enrolled and assigned to either the split-dose 2-L PEG-Asc group or the 1-L PEG-Asc with bisacodyl 10-mg group. The Boston Bowel Preparation Scale (BBPS) and Aronchick Bowel Preparation Scale (ABPS) were used to evaluate bowel cleansing. The tolerability of the regimens and satisfaction of patients was determined based on a questionnaire. RESULTS: Two hundred patients received either 2-L PEG-Asc or 1-L PEG-Asc with bisacodyl. Regarding colon cleansing outcome (BBPS and ABPS), the 1-L PEG-Asc with bisacodyl group showed similar but non-inferior results compared with the 2-L PEG-Asc group on both BBPS (6.92 ± 1.63 vs 6.57 ± 1.37; P = .103) and ABPS (96% vs 95%; P = 1.000) scales. Tolerability was similar for both 1-L PEG-Asc with bisacodyl and 2-L PEG-Asc. CONCLUSIONS: 1-L PEG-Asc is a suitable alternative to low-volume bowel preparation for colonoscopy. Our study showed that the 1-L PEG-Asc plus bisacodyl preparation has comparable tolerability and results in adequate colon cleansing. Bowel preparation with bisacodyl and 1-L PEG-Asc is a suitable alternative to low-volume bowel preparation for colonoscopy. (Clinical trial registration number: NCT02980562.).

Comparison of efficacy of pharmacological treatments for chronic idiopathic constipation: a systematic review and network meta-analysis.

OBJECTIVE: To compare efficacy of pharmacotherapies for chronic idiopathic constipation (CIC) based on comparisons to placebo using Bayesian network meta-analysis. DATA SOURCES: We conducted searches (inception to May 2015) of MEDLINE, EMBASE, Scopus and Cochrane Central, as well as original data from authors or drug companies for the medications used for CIC. STUDY SELECTION: Phase IIB and phase III randomised, placebo-controlled trials (RCT) of ≥4 weeks' treatment for CIC in adults with Rome II or III criteria for functional constipation; trials included at least one of four end points. DATA EXTRACTION AND SYNTHESIS: Two investigators independently evaluated all full-text articles that met inclusion criteria and extracted data for primary and secondary end points, risk of bias and quality of evidence. OUTCOMES: Primary end points were ≥3 complete spontaneous bowel movements (CSBM)/week and increase over baseline by ≥1 CSBM/week. Secondary end points were change from baseline (Δb) in the number of SBM/week and Δb CSBM/week. RESULTS: Twenty-one RCTs (9189 patients) met inclusion and end point criteria: 9 prucalopride, 3 lubiprostone, 3 linaclotide, 2 tegaserod, 1 each velusetrag, elobixibat, bisacodyl and sodium picosulphate (NaP). All prespecified end points were unavailable in four polyethylene glycol studies. Bisacodyl, NaP, prucalopride and velusetrag were superior to placebo for the ≥3 CSBM/week end point. No drug was superior at improving the primary end points on network meta-analysis. Bisacodyl appeared superior to the other drugs for the secondary end point, Δb in number of SBM/week. CONCLUSIONS: Current drugs for CIC show similar efficacy. Bisacodyl may be superior to prescription medications for Δb in the number of SBM/week in CIC.