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

BackgroundReducing 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.Aimsto 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.MethodsOutpatients 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.ResultsSplit-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.ConclusionsThe 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)     

Polyethylene glycol versus sodium picosulfalte bowel preparation in the setting of a colorectal cancer screening program

BACKGROUND:

Adequate bowel preparation for colonoscopy is an important predictor of colonoscopy quality.

OBJECTIVE:

To determine the difference in terms of effectiveness between different existing colon cleansing products in the setting of a colorectal cancer screening program.

METHODS:

The records of consecutive patients who underwent colonoscopy at the Montreal General Hospital (Montreal, Quebec) between April 2013 and April 2014 were retrospectively extracted from a dedicated electronic digestive endoscopic institutional database.

RESULTS:

Overall, 2867 charts of patients undergoing colonoscopy were assessed, of which 1130 colonoscopies were performed in a screening setting; patients had adequate bowel preparation in 90%. Quality of preparation was documented in only 61%. Bowel preparation was worse in patients receiving sodium picosulfate (PICO) alone compared with polyethylene glycol, in a screening setting (OR 0.3 [95% CI 0.2 to 0.6]). Regardless of the preparation type, the odds of achieving adequate quality cleansing was 6.6 for patients receiving a split-dose regimen (OR 6.6 [95% CI 2.1 to 21.1]). In multivariable analyses, clinical variables associated with inadequate bowel preparation in combined population were use of PICO, a nonsplit regimen and inpatient status. The polyp detection rate was very high (45.6%) and was correlated with withdrawal time.

CONCLUSION:

Preparation quality needs to be more consistently included in the colonoscopy report. Split-dose regimens increased the quality of colon cleansing across all types of preparations and should be the preferred method of administration. Polyethylene glycol alone provided better bowel cleansing efficacy than PICO in a screening setting but PICO remains an alternative in association with an adjuvant.     

Efficacy and Tolerability of Split-Dose PEG Compared with Split-Dose Aqueous Sodium Phosphate for Outpatient Colonoscopy: A Randomized,Controlled Trial

Background and Aims  

Adequate bowel cleansing is essential for a high-quality, effective, and safe colonoscopy. The aims of this study were to compare the efficacy and tolerability of split-dose polyethylene glycol with aqueous sodium phosphate for outpatients who underwent scheduled colonoscopy.     

Update on Bowel Preparation for Colonoscopy

Purpose of review

Colonoscopy is the gold standard for visualization and diagnosis of conditions involving the colon and terminal ileum. It also facilitates screening and prevention of colorectal cancer, which is the second leading cause of cancer death in the USA. Adequate cleansing is essential for thorough visualization of the colon with successful detection of colon polyps.

Recent findings

While the original large-volume polyethylene glycol preparations are still commonly used, several lower volume regimens are widely available and selected based on provider and patient preferences. There remains a strong urge from patients for an even lower volume and more palatable regimen. Split-dose preparation is strongly recommended and additional data has come to support same-day preparation regimens as well. Despite extensive research and comparison of various preparation regimens, between 10 and 25% of patients continue to have inadequate colon cleansing on the day of colonoscopy. Several patient factors have been associated with poor preparation and this chapter will touch on scoring systems, which may be used to predict colon cleansing. Documentation of preparation quality is essential to guide the practitioner in timing of follow-up examination. We recommend the use of the Boston Bowel Preparation Scale (BBPS) which is a validated and reliable scale for evaluation of cleansing. In patients with an inadequate preparation, we emphasize the importance of repeat examinations with consideration of a more aggressive preparation regimen. We predict that dietary liberalization prior to colonoscopy will be more commonly practiced in the future as it improves both patient satisfaction and adherence.

Summary

Thorough bowel cleansing is essential for visualization of the colon with successful detection of colon polyps. While polyethylene glycol regimens are still the most commonly used for preparation, recommendations regarding dose timing and volume continue to evolve to optimize patient satisfaction and success of bowel cleanse. As the patients presenting for colonoscopy are evermore complex with medical comorbidities and extensive medication lists, a patient-centered approach to colonoscopy preparation will likely yield the highest rates of success.

     

1L- vs. 4L-Polyethylene glycol for bowel preparation before colonoscopy among inpatients: A propensity score-matching analysis

BackgroundInpatients are at risk for inadequate colon cleansing. Experts recommend 4L-polyethylene-glycol (PEG) solution. A higher colon cleansing adequacy rate for a hyperosmolar 1L-PEG plus ascorbate prep has been recently reported.AimsWe aimed to determine whether 1L-PEG outperforms 4L-PEG among inpatients.Methodspost-hoc analysis of a large Italian multicenter prospective observational study among inpatients (QIPS study). We performed a propensity score matching between 1L-PEG and 4L-PEG group. The primary outcome was the rate of adequate colon cleansing as assessed by unblinded endoscopists through Boston scale. Secondary outcome was the safety profile.ResultsAmong 1,004 patients undergoing colonoscopy, 724 (72%) were prescribed 4L-PEG and 280 (28%) 1L-PEG. The overall adequate colon cleansing rate was 69.2% (n = 695). We matched 274 pairs of patients with similar distribution of confounders. The rate of patients with adequate colon cleansing was higher in 1L-PEG than in 4L-PEG group (84.3% vs. 77.4%, p = 0.039). No different shift in serum concentration of electrolytes (namely Na⁺, K⁺, Ca²⁺), creatinine and hematocrit were observed for both preparations.ConclusionWe found a higher rate of adequate colon cleansing for colonoscopy with the 1L-PEG bowel prep vs. 4L-PEG, with apparent similar safety profile, among inpatients. A confirmatory randomized trial is needed. (ClinicalTrials.gov no: NCT04310332)     

Overall acceptability and efficacy of commonly used bowel preparations for colonoscopy in Italian clinical practice. A multicentre prospective study

Background & aimsThe recent enormous increase in colonoscopy demand prompted this multicentre observational study assessing overall acceptability and efficacy of commonly used bowel preparations in Italian clinical practice.MethodsConsecutive outpatients undergoing colonoscopy were recruited from 9 major gastroenterological centres in Italy. Each patient evaluated overall acceptability of the bowel cleansing preparation through a 0–100 mm Visual Analogue Scale. The Visual Analogue Scale score was dichotomized by a median split: 80–100 (high acceptability) vs. 0–79 (low acceptability). Bowel cleansing was assessed through a validated scale. The influence of potential individual determinants on patients’ acceptability and cleansing efficacy of the bowel preparations was determined by multivariate analyses.Results599 evaluable patients were enrolled; 57.3% received 4L-PEG preparations, 29.5% 2L-PEG preparations and 13.2% 2-glasses-solutions (Na-phosphate/Mg-citrate/Na-picosulphate-containing preparations). Overall acceptability was significantly higher for 2L-PEG and 2-glasses solutions than 4L-PEG (adjusted odds ratio, 4.72; and adjusted odds ratio 2.07, respectively). Successful bowel cleansing achieved with 4L-PEG (85.9%) was similar to 2L-PEG (85.3%; adjusted odds ratio 0.82) and significantly higher than 2-glasses solutions (69.6%; adjusted odds ratio 0.34 vs. 4L-PEG). Split regimen, lower total preparation volume and colonoscopy reason (periodical control vs. 1st procedure) were significantly associated with high acceptability. Age ≥60 years, dissatisfaction with the preparation taken, and ≤4/week bowel movements were major determinants of a poor bowel cleansing.Conclusions2L-PEG and 4L-PEG preparations provide the most effective bowel cleansing for colonoscopy in clinical practice, with a significantly higher acceptability for 2L-PEG preparations.     

Split-dose vs same-day reduced-volume polyethylene glycol electrolyte lavage solution for morning colonoscopy

AIM: To compare same-day whole-dose vs split-dose of 2-litre polyethylene glycol electrolyte lavage solution (PEG-ELS) plus bisacodyl for colon cleansing for morning colonoscopy.METHODS: Consecutive adult patients undergoing morning colonoscopy were allocated into two groups i.e., same-day whole-dose or split-dose of 2-litre PEG-ELS. Investigators and endoscopists were blinded to the allocation. All patients completed a questionnaire that was designed by Aronchick and colleagues to assess the tolerability of the bowel preparation regime used. In addition, patients answered an ordinal five-value Likert scale question on comfort level during bowel preparation. Endoscopists graded the quality of bowel preparation using the Boston bowel preparation scale (BBPS). In addition, endoscopists gave an overall grading of the quality of bowel preparation. Cecal intubation time, withdrawal time, total colonoscopy time, adenoma detection rate and number of adenomas detected for each patient were recorded. Sample size was calculated using an online calculator for binary outcome non-inferiority trial. Analyses was based upon intent-to-treat. Significance was assumed at P-value < 0.05.RESULTS: Data for 295 patients were analysed. Mean age was 62.0 ± 14.4 years old and consisted of 50.2 % male. There were 143 and 152 patients in the split-dose and whole-dose group, respectively. Split-dose was as good as whole-dose for quality of bowel preparation. The total BBPS score was as good in the split-dose group compared to the whole-dose group [6 (6-8) vs 6 (6-7), P = 0.038]. There was no difference in cecal intubation rate, cecal intubation time, withdrawal time, total colonoscopy time and adenoma detection rate. Median number of adenoma detected was marginally higher in the split-dose group [2 (1-3) vs 1 (1-2), P = 0.010]. Patients in the whole-dose group had more nausea (37.5% vs 25.2%, P = 0.023) and vomiting (16.4% vs 8.4%, P = 0.037), and were less likely to complete the bowel preparation (94.1% vs 99.3%, P = 0.020). Patients in the split-dose group were less likely to refuse the same bowel preparation regime (6.3% vs 13.8%, P = 0.033) and less likely to want to try another bowel preparation regime (53.8% vs 78.9%, P < 0.001).CONCLUSION: Splitting reduced-volume PEG-ELS for morning colonoscopy is as effective as taking the whole dose on the same morning but is better tolerated and preferred by patients.     

The use of low-volume polyethylene glycol containing ascorbic acid versus 2 L of polyethylene glycol plus bisacodyl as bowel preparation for colonoscopy

Abstract

Objective. Low-volume polyethylene glycol (PEG) bowel preparations have been developed to improve compliance for colonoscopy. Our study aimed to compare the efficacy and tolerability of low-volume PEG containing ascorbic acid for colonoscopy against 2 L of PEG plus bisacodyl. Methods. We prospectively enrolled consecutive inpatients who had not undergone polypectomy at the index colonoscopy and were subsequently referred for polypectomy at our hospital. A total of 62 patients were randomized to receive either low-volume PEG containing ascorbic acid (n = 31) or 2 L of PEG plus bisacodyl (n = 31) as a split-dose regimen in inpatients. The efficacy of preparation was determined using the Ottawa Bowel Preparation Score (OBPS) and a 4-point scale. Adverse events, tolerability, and willingness were evaluated using a questionnaire. Results. Based on the OBPS and 4-point scale, we determined that the efficacy of low-volume PEG containing ascorbic acid was comparable to that of the 2 L of PEG plus bisacodyl (p = 0.071 for OBPS, p = 0.056 for the 4-point scale). Adverse events were comparable between the two groups (p = 1.000). A greater proportion of patients in the low-volume PEG containing ascorbic acid (90.6%) and the 2L of PEG plus bisacodyl (96.9%) were willing to repeat the same preparation for subsequent colonoscopy.Conclusion. Low-volume PEG containing ascorbic acid had comparable efficacy and tolerability to 2 L of PEG plus bisacodyl, when given as a split dose, for colonoscopy in inpatients. Split-dose low-volume PEG containing ascorbic acid is a good alternative for bowel preparation for colonoscopy in inpatients.     

A new low-volume isosmotic polyethylene glycol solution plus bisacodyl versus split-dose 4 L polyethylene glycol for bowel cleansing prior to colonoscopy: A randomised controlled trial

Background4-L polyethylene glycol preparations are effective for colon cleansing before colonoscopy. However, large volume and unpleasant taste reduce tolerability and acceptability limiting patient compliance. A new isosmotic low-volume polyethylene glycol preparation with citrates and simethicone plus bisacodyl has been developed to improve patient compliance and tolerability.AimTo compare the efficacy of 2 different regimens of preparation vs a split-dose of polyethylene glycol solution.Patients and methodsIn this randomised, blinded, comparative study, 153 patients were allocated to 3 arms. Arm 1 (n = 52) received bisacodyl and 2-L polyethylene glycol with citrates and simethicone the day before the procedure. Arm 2 (n = 50) received bisacodyl the day before and 2-L polyethylene glycol with citrates and simethicone on the day of colonoscopy. Control group (n = 51) received a split-dose of 4-L polyethylene glycol. Cleansing was evaluated according to Ottawa scale.ResultsThe mean Ottawa score was not different in the 3 groups. Excellent cleansing was observed more frequently in arm 2 (70%) than in controls (49%) (p < 0.05). No serious adverse events were observed in the 3 regimens. The willingness to repeat the same bowel preparation was superior in arms 1 and 2 than in controls (p < 0.001).ConclusionsNew low-volume preparations seem to be as effective as the split 4-L polyethylene glycol regimen, showing a better tolerability and acceptability.     

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 cleans...     

Comparison of split-dosing vs non-split (morning) dosing regimen for assessment of quality of bowel preparation for colonoscopy

AIM: To compare (using the Ottawa Bowel Preparation Scale) the efficacy of split-dose vs morning administration of polyethylene glycol solution for colon cleansing in patients undergoing colonoscopy, and to assess the optimal preparation-to-colonoscopy interval.METHODS: Single-centre, prospective, randomized, investigator-blind stud in an academic tertiary-care centre. Two hundred patients requiring elective colonoscopy were assigned to receive one of the two preparation regimens (split vs morning) prior to colonoscopy. Main outcome measurements were bowel preparation quality and patient tolerability.RESULTS: Split-dose regimen resulted in better bowel preparation compared to morning regimen [Ottawa score mean 5.52 (SD 1.23) vs 6.02 (1.34); P = 0.017]. On subgroup analysis, for afternoon procedures, both the preparations were equally effective (P = 0.756). There was no difference in tolerability and compliance between the two regimens.CONCLUSION: Overall, previous evening - same morning split-dosing regimen results in better bowel cleansing for colonoscopy compared to morning preparation. For afternoon procedures, both schedules are equally effective; morning preparation may be more convenient to the patient.     

Clinical management and patient outcomes of acute lower gastrointestinal bleeding. A multicenter,prospective, cohort study

Background & aimAlthough acute lower GI bleeding (LGIB) represents a significant healthcare burden, prospective real-life data on management and outcomes are scanty. Present multicentre, prospective cohort study was aimed at evaluating mortality and associated risk factors and at describing patient management.MethodsAdult outpatients acutely admitted for or developing LGIB during hospitalization were consecutively enrolled in 15 high-volume referral centers. Demographics, comorbidities, medications, interventions and outcomes were recorded.ResultsOverall 1,198 patients (1060 new admissions;138 inpatients) were included. Most patients were elderly (mean-age 74±15 years), 31% had a Charlson-Comorbidity-Index ≥3, 58% were on antithrombotic therapy. In-hospital mortality (primary outcome) was 3.4% (95%CI 2.5–4.6). At logistic regression analysis, independent predictors of mortality were increasing age, comorbidity, inpatient status, hemodynamic instability at presentation, and ICU-admission. Colonoscopy had a 78.8% diagnostic yield, with significantly higher hemostasis rate when performed within 24-hours than later (21.3% vs.10.8%, p = 0.027). Endoscopic hemostasis was associated with neither in-hospital mortality nor rebleeding. A definite or presumptive source of bleeding was disclosed in 90.4% of investigated patients.ConclusionMortality in LGIB patients is mainly related to age and comorbidities. Although early colonoscopy has a relevant diagnostic yield and is associated with higher therapeutic intervention rate, endoscopic hemostasis is not associated with improved clinical outcomes [ClinicalTrial.gov number: NCT 04364412].     

Sodium phosphate is superior to polyethylene glycol in bowel cleansing and shortens the time it takes to visualize colon mucosa

Background: Both sodium phosphate (NaP) and polyethylene glycol‐electrolyte (PEG‐EL) have been used to cleanse the bowel prior to colonoscopy, and recent reviews suggest that the former is the more effective and convenient cleansing regimen. The aim of this study was to compare the bowel cleansing effect of NaP solution with that of PEG‐EL solution and to evaluate whether the cleansing effect correlates with the time needed to perform colonoscopy. Methods: 111 patients admitted for colonoscopy were randomized to receive either 90?mL oral NaP or 4?litres of PEG‐EL solution. Cleansing was scored blindly by one colonoscopist and the following times were recorded: caecal intubation, withdrawal and total colonoscopy. Results: Of all the patients included in the study, 99 were evaluable. The mean and standard error of the mean (±s_x ) cleansing score was 3.64?±?0.16 in the NaP group and 2.69?±?0.9 in the PEG‐EL group (P?=?0.005). The mean (±s_x ) caecal intubation times were 6.39?±?0.50?min and 5.39?±?0.41?min (P?=?0.13), the withdrawal times 4.26?±?0.20?min and 5.78?±?0.34?min (P?=?0.0001) and the total colonoscopy times 10.65?±?0.52?min and 11.17?±?0.56?min (P?=?0.50) in the NaP and PEG‐EL groups, respectively. The subgroup of patients with a cleansing score of 3 or more was associated with shortened colonoscopy withdrawal time compared to the group scoring below 3. Conclusions: Better cleansing of the large bowel shortens colonoscopy withdrawal time. Sodium phosphate is a more effective bowel‐cleansing regimen than polyethylene glycol, and the better cleansing result is associated with shortened colonoscopy withdrawal time.     

Bisacodyl plus split 2-L polyethylene glycol-citrate-simethicone improves quality of bowel preparation before screening colonoscopy

AIM:To compare the bowel cleansing efficacy,tolerability and acceptability of split 2-L polyethylene glycol(PEG)-citrate-simethicone(PEG-CS)plus bisacodyl(BIS)vs 4-L PEG for fecal occult blood test-positive screening colonoscopy.METHODS:This was a randomised,observer-blind comparative study.Two hundred and sixty-four subjects underwent screening colonoscopy(mean age 62.5±7.4years,male 61.7%).The primary objective of the study was to compare the bowel cleansing efficacy of the two preparations.Interventions:BIS plus PEG-CS:3 tablets of 5-mg BIS at 16:00,PEG-CS 1-L at 19:00 and 1-L at7:00,4-L PEG:3-L at 17:00,and 1-L at 7:00.Colonoscopy was carried out after 11:00,at least 3 h after the completion of bowel preparation.Bowel cleansing was evaluated using the Harefield Cleansing Scale.RESULTS:Bowel preparation was successful for 92.8%of subjects in the PEG-CS group and for 92.1%of subjects in the 4-L PEG(RR=1.01;95%CI:0.94-1.08).BIS+PEG-CS was better tolerated than 4-L PEG.A greater rate of patients in the BIS+PEG-CS group had no difficulty and/or were willing to repeat the same preparation compared to split-dose 4-L PEG group.Subjects in the BIS+PEG-CS group rated the prep as good or satisfactory in 90.6%as compared to 77%in the 4-L PEG(P=0.003).Subjects receiving BIS+PEGCS stated they fully adhered to instructions drinking all the 2-L solution in 97.1%compared with 87.3%in the4-L PEG(P=0.003).CONCLUSION:BIS plus split 2-L PEG-CS was as effective as but better tolerated and accepted than split4-L PEG for screening colonoscopy.This new procedure may increase the positive attitude and participation to colorectal cancer screening colonoscopy.     

Predictors of Suboptimal Bowel Preparation Using 3-l of Polyethylene Glycol for an Outpatient Colonoscopy: A Prospective Observational Study

Background

A 3-l polyethylene glycol (PEG) solution provided better bowel cleansing quality than a 2-l solution for outpatient colonoscopy. Predictors of suboptimal preparation using a 3-l PEG have not been previously reported.

Aims

To investigate the possible predictors of suboptimal bowel preparation using 3-l of PEG.

Methods

We analyzed a database of 1404 consecutive colonoscopies during a 27-month period at a community hospital. A split-dose PEG regimen was provided for morning colonoscopies, and a same-day PEG regimen was provided for afternoon colonoscopies. The level of bowel cleansing was prospectively scored according to the Boston Bowel Preparation Scale (BBPS). Possible predictors of suboptimal colon preparation, defined as a BBPS score <7, were analyzed using univariate statistics and multivariate logistic regression models.

Results

The mean age of the study population (46.7 % men) was 52.5 years (range 20–80 years, SD 11.1 years), and the majority of patients (77.6 %) underwent morning colonoscopies. A suboptimal bowel preparation was reported in 17.2 % of the observed colonoscopies. In the multivariate regression analysis, constipation (odds ratio [OR] 1.60, 95 % confidence interval [CI] 1.15–2.22), male gender (OR 1.68, 95 % CI 1.25–2.25), obesity (OR 1.76, 95 % CI 1.29–2.41), and inadequate (<80 %) PEG consumption (OR 5.4, 95 % CI 2.67–10.89) were independent predictors of a suboptimal colon preparation.

Conclusions

This prospective study identified that constipation, male gender, obesity, and inadequate intake of PEG were significant risk factors for suboptimal bowel preparation using a 3-l PEG solution for outpatient colonoscopy. Interventions of optimized colonoscopy preparation should be targeted at these patient populations.

     

Same-day 2-L PEG-citrate-simethicone plus bisacodyl vs split 4-L PEG: Bowel cleansing for late-morning colonoscopy

AIM: To evaluate the efficacy, tolerability, acceptability and feasibility of bisacodyl plus low volume polyethyleneglycol-citrate-simeticone(2-L PEG-CS) taken the same day as compared with conventional split-dose 4-L PEG for late morning colonoscopy. METHODS: Randomised, observer-blind, parallel group, comparative trial carried out in 2 centres. Out patients of both sexes, aged between 18 and 85 years, undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up were eligible. The PEG-CS group received 3 bisacodyl tablets(4 tablets for patients with constipation) at bedtime and 2-L PEG-CS in the morning starting 5 h before colonoscopy. The control group received a conventional 4-L PEG formulation given as split regimen; the morning dose was taken with the same schedule of the low volume preparation. The Ottawa Bowel Preparation Scale(OBPS) score was used as the main outcome measure.RESULTS: A total of 164 subjects were enrolled and 154 completed the study; 78 in the PEG-CS group and 76 in the split 4-L PEG group. The two groups were comparable at baseline. The OBPS score in the PEG-CS group(3.09 ± 2.40) and in the PEG group(2.39 ± 2.55) were equivalent(difference +0.70; 95%CI:-0.09-1.48). This was confirmed by the rate of successful bowel cleansing in the PEG-CS group(89.7%) and in the PEG group(92.1%)(difference-2.4%; 95%CI:-11.406.70). PEG-CS was superior in terms of mucosa visibility compared to PEG(85.7% vs 72.4%, P = 0.042). There were no significant differences in caecum intubation rate, time to reach the caecum and withdrawal time between the two groups. The adenoma detection rate was similar(PEG-CS 43.6% vs PEG 44.7%). No serious adverse events occurred. No difference was found in tolerability of the bowel preparations. Compliance was equal in both groups: more than 90% of subjects drunk the whole solution. Willingness to repeat the same bowel preparations was about 90% for both regimes. CONCLUSION: Same-day PEG-CS is feasible, effective as split-dose 4-L PEG for late morning colonoscopy and does not interfere with work and daily activities the day before colonoscopy.     

Efficacy and Safety of TJP-008 Compared to 2 L PEG with Ascorbate in Colon Cleansing: A Randomized Phase 3 Trial

Background/AimsPolyethylene glycol (PEG)-based bowel preparations are effective cleansing agents for colonoscopy. However, they require relatively large volumes to be used even with agents such as 2 L PEG with ascorbate (2LPEG). This phase 3, randomized, single-blinded, multicenter, parallel-group study compared the efficacy of 1 L PEG with high-dose ascorbate, TJP-008, to 2LPEG.MethodsPatients undergoing colonoscopy were randomized (111) to receive TJP-008 as 1-day split dose (TJP-008-1) or 2-day split dose (TJP-008-2) regimen or to receive 2LPEG as a 2-day split dose regimen. Cleansing efficacy was evaluated using the Harefield Cleansing Scale. The primary endpoint was overall bowel cleansing success. Full analysis set (FAS) and per protocol set (PPS) analyses were performed.ResultsOf the 314 screened patients, efficacy was assessed in the following patient numbers (FAS/PPS) total (293/285), TJP-008-1 (98/94), TJP-008-2 (97/95), and 2LPEG (98/96). FAS revealed noninferiority between TJP-008 and 2LPEG with regard to overall success (TJP-008-2, 99.0%; TJP-008-1, 95.9%; 2LPEG, 94.9%; p=0.100 and p=0.733, respectively). PPS also showed noninferiority (p=0.721 and p=0.211, respectively). However, the PPS analyses showed a higher bowel cleansing score for TJP-008-2 for high-quality cleansing in the right colon (TJP-008-2 83.2% vs 2LPEG 62.5%; p=0.005).ConclusionsTJP-008 is a new low-volume cleansing agent with a colon cleansing efficacy comparable to that of standard 2LPEG that exhibits significant safety and tolerability.     

Predictive factors for inadequate bowel cleansing in colon capsule endoscopy

Background and aimsAchieving adequate bowel cleansing is of utmost importance for the efficiency of colon capsule endoscopy (CCE). However, information about predictive factors is lacking. The aim of this study was to assess the predictive factors of poor bowel cleansing in the CCE setting.MethodsIn this observational study, 126 patients who underwent CCE at two tertiary care hospitals were included between June 2017 and January 2020. Participants prepared for bowel cleansing with a 1-day clear liquid diet, a 4-L split-dose polyethylene glycol regimen and boosters with sodium phosphate, sodium amidotrizoate and meglumine amidotrizoate. Domperidone tablets and bisacodyl suppositories were administered when needed. Overall and per-segment bowel cleansing was evaluated using a CCE cleansing score. Simple and multiple logistic regression analysis were carried out to assess poor bowel cleansing and excretion rate predictors.ResultsOverall bowel cleansing was optimal in 53 patients (50.5%). Optimal per-segment bowel cleansing was achieved as follows: cecum (86 patients; 74.8%), transverse colon (91 patients; 81.3%), distal colon (81 patients; 75%) and rectum (64 patients; 66.7%). In the univariate analysis, elderly (OR, 1.03; 95% CI (1.01–1.076)) and constipation (OR, 3.82; 95% CI (1.50–9.71)) were associated with poor bowel cleansing. In the logistic regression analysis, constipation (OR, 3.77; 95% CI (1.43–10.0)) was associated with poor bowel cleansing. No variables were significantly associated with the CCE device excretion rate.ConclusionOur results suggest that constipation is the most powerful predictor of poor bowel cleansing in the CCE setting. Tailored cleansing protocols should be recommended for these patients.     

Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean®) with a polyethylene glycol/bisacodyl kit

BACKGROUNDEfficient bowel cleansing is essential for a successful colonoscopy, but the ideal cleansing agent, volume, and pharmaceutical dosage form have yet to be determined. Small-volume cleansers enhance patient compliance.AIMTo compare the bowel cleansing efficacy of 32-tablet sodium phosphate (Quiklean^®) with 2-L polyethylene glycol (PEG)/bisacodyl (Klean-Prep/ Dulcolax^®) under identical dietary recommendations.METHODSThis multicenter, randomized, parallel-group, noninferiority clinical trial enrolled 472 outpatients, randomized 456 subjects, and scheduled 442 subjects to undergo colonoscopy (Quiklean^® = 222 and Klean-Prep/Dulcolax^® = 220). After bowel preparation, a colonoscopist performed the colonoscopy with video recorded for rating. The primary efficacy endpoint was the bowel cleansing quality using the Aronchick Scale. The secondary endpoints were the bowel cleansing efficacy of three colon segments, tolerability and acceptability, safety using the Ottawa bowel preparation scale, questionnaires by subjects, and monitoring of adverse events.RESULTSSuccess rates (Excellent + Good) of the bowel cleansing quality by Aronchick Scale were 98.6% (n = 205) and 97.6% (n = 204) in the Quiklean^® and Klean-Prep/Dulcolax^® groups, respectively. Quiklean^® demonstrated noninferiority over Klean-Prep/Dulcolax^® in colon cleansing efficacy. Quicken showed better tolerability and acceptability in the overall experience (was rated as excellent; 24.0% vs 17.2%; P = 0.0016) and the taste of the study preparation (was rated as excellent, 23.1% vs 13.4%; P < 0.0001) than Klean-Prep/Dulcolax^®. Safety profiles did not differ between the two groups. Our data indicate that Quiklean^® is an adequate, well-tolerated bowel cleansing preparation compared with the standard comparator Klean-Prep/Dulcolax^®.CONCLUSIONQuiklean^® is sodium phosphate tablets available on Taiwan’s market for bowel preparation; it potentially offers patients an alternative to standard large-volume bowel preparation regimens and may, therefore, increase positive attitudes toward colonoscopies and participation rates.     

PillCamColon2 after incomplete colonoscopy-A prospective multicenter study

AIM To evaluate the ability of PillCamColon2 to visualize colonic segments missed by incomplete optical colonoscopy(OC) and to assess the diagnostic yield.METHODS This prospective multicentre study included 81 patients from nine centres who underwent second-generation colon capsule endoscopy(CCE) following incomplete OC performed by an experienced gastroenterologist( 1000 colonoscopies). Patients with stenosis were excluded. According to patient preferences, CCE was performed the following day(protocol A) after staying on clear liquids and 0.75 L Moviprep in the morning or within 30 d after new split-dose Moviprep(protocol B). Boosts consisted of 0.75 L and 0.25 L Moviprep, and phospho-soda was given as a rescue if the capsule was not excreted after seven hours.RESULTS Seventy-four patients were analysed(51% of them in group A; 49% in group B). Bowel cleansing was adequate in 67% of cases, and CCE could visualize colonic segments missed by incomplete colonoscopy in 90% of patients under protocol A and 97% of patients under protocol B(P = 0.35, n.s.). Significant polyps including adenocarcinoma were detected in 24% of cases. Detection rates for all polyps and significant polyps per patient were similar in both protocols. Polyps were found predominantly in the right colon(86%) in segments that were not reached by OC. Extracolonic findings-such as reflux esophagitis, suspected Barrett esophagus, upper GI-bleeding, gastric polyps, gastric erosions and angiectasia-were detected in eight patients. Pill Cam Colon2 capsule was retained in the ileum of one patient(1.4%) without symptoms and removed during an uneventful resection for unknown Crohn's disease that was diagnosed as the cause of anemia, which was the indication for colonoscopy. CCE was well tolerated. One patient suffered from selflimiting vomiting after consuming the phospho-soda.CONCLUSION Second-generation CCE using a low-volume preparation is useful after incomplete OC, and it allows for the detection of additional relevant findings, but cleansing efficiency could be improved.