scholarly journals Bowel-cleansing efficacy of the 1L polyethylene glycol-based bowel preparation NER1006 (PLENVU) in patient subgroups in two phase III trials

2021 ◽  
Vol 14 ◽  
pp. 175628482110202
Author(s):  
Sandra Baile-Maxia ◽  
Bharat Amlani ◽  
Rodrigo Jover Martínez
Keyword(s):  
Colorectal Cancer ◽  
Polyethylene Glycol ◽  
High Risk ◽  
Bowel Preparation ◽  
Phase Iii ◽  
Plain Language ◽  
Split Dose ◽  
Adenoma Detection ◽  
Increased Risk ◽  
Bowel Cleansing

Background: Adequate bowel preparation prior to colonoscopy is essential for visualization of the colonic mucosa to maximize adenoma and polyp detection. The risk of inadequate bowel cleansing is heightened if the patient is older, male, overweight, and has comorbidities, such as diabetes. This post hoc analysis of the combined MORA and NOCT clinical trials explores the efficacy of evening/morning split-dose regimens of NER1006 (PLENVU®, Norgine Ltd), a 1-liter polyethylene glycol (PEG) bowel preparation, to evaluate its bowel-cleansing efficacy in patients at risk for inadequate cleansing. Methods: Patients requiring colonoscopy were randomized to receive evening/morning split-dosing of either NER1006, 2-liter (2L) PEG and ascorbate, or oral sulfate solution (OSS). Bowel-cleansing efficacy was assessed by treatment-blinded central readers using the validated Harefield Cleansing Scale (HCS). Results: Split-dose NER1006 was associated with high levels of cleansing, ranging between 87.0% and 94.0% across all patient subtypes ( n = 551), including patients with obesity or diabetes. However, patients aged >65 years and <45 years showed significantly greater rates of successful cleansing than patients aged 45–65 years (94.0% versus 94.2% versus 87.0%, p = 0.002). The high-risk patient subgroup, which included obese males aged ⩾60 years, had significantly improved overall and high-quality bowel-cleansing success rates of 100% (33/33) and 72.7% (27/33) on the HCS with NER1006, compared with 86.7% (26/30) and 50% (15/30) with the comparator solutions ( p = 0.015 and p = 0.033, respectively). In this high-risk subgroup, adenoma detection was greater per patient receiving NER1006 versus the comparator group (1.82 versus 0.93, p = 0.041). NER1006 was the only treatment that enabled the detection of patients with ⩾5 adenomas [9.1% (3/33) versus 0/30, p = 0.047]. Conclusion: NER1006 effectively cleansed a broad range of patients and offered superior bowel cleansing versus 2LPEG/OSS in patients at increased risk of colorectal cancer. Future research should establish whether more effective cleansing also enables improved adenoma detection. Plain language summary A low-volume bowel preparation solution to better detect lesions associated with colorectal cancer during colonoscopy Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world. Obese men over the age of 65 years are at particularly increased risk of developing CRC. If the changes in their large intestine (colon) could be seen more clearly during a colonoscopy (where a small camera is inserted via the anus to examine the bowels from the inside), patients who need treatment would be diagnosed earlier, thus improving their chances of survival. In this paper we discuss the use of a bowel preparation solution that is more convenient for patients (less to drink) but also cleans bowels more effectively, meaning more lesions are detected than when other solutions are used. This improved cleansing, and thus better visualization, occurred in a range of patients, including those at higher risk of CRC, such as older, overweight men.

scholarly journals Gastric Residual Volume after Split-Dose Bowel Preparation versus Conventional Single-Dose Regimen before Anesthetic Colonoscopy

2017 ◽  
Vol 2017 ◽  
pp. 1-4
Author(s):  
Shi-gui Xue ◽  
Han-lin Chen ◽  
Chun-sheng Cheng ◽  
Bao-sheng Huang ◽  
Hou-de Zhang
Keyword(s):  
Single Dose ◽  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Dose Group ◽  
Prospective Observational Study ◽  
Residual Volume ◽  
Gastric Residual Volume ◽  
Split Dose ◽  
Bowel Cleansing ◽  
Risk Of Aspiration

The aim of this study was to compare gastric residual volume (GRV) in patients given a split-dose versus a conventional single-dose of polyethylene glycol (PEG) preparation before undergoing anesthetic colonoscopy. Methods. In a prospective observational study, we assessed GRV in outpatients undergoing same-day anesthetic gastroscopy and colonoscopy between October 8 and December 30 of 2016. Outpatients were assigned to the split-dose (1 L PEG in the prior evening and 1 L PEG 2–4 h before endoscopy) or single-dose (ingestion of 2 L PEG ≥ 6 h before endoscopy) regimen randomly. Bowel cleansing quality was assessed with the Boston Bowel Preparation Scale (BBPS). Results. The median GRV in the split-dose group (17 ml, with a range of 0–50 ml; N=65) was significantly lower than that in the single-dose group (22 ml, with a range of 0–62 ml; N=64; p=0.005), with a better bowel cleansing quality (BBPS score 8.05±0.82 versus 7.64±1.21; p=0.028). GRV was not associated with diabetes or the use of medications. Conclusions. GRV after a split-dose preparation and fasting for 2–4 hours is not larger than that after a conventional single-dose preparation and fasting for 6–8 hours. The data indicates that the split-dose bowel preparation might not increase the risk of aspiration.

scholarly journals Polyethylene Glycol versus sodium picosulfalte Bowel Preparation in the Setting of a Colorectal Cancer Screening Program

2015 ◽  
Vol 29 (7) ◽  
pp. 384-390 ◽  
Author(s):  
Omar Kherad ◽  
Sophie Restellini ◽  
Myriam Martel ◽  
Alan N Barkun
Keyword(s):  
Colorectal Cancer ◽  
Polyethylene Glycol ◽  
Cancer Screening ◽  
Colorectal Cancer Screening ◽  
Bowel Preparation ◽  
Screening Program ◽  
Split Dose ◽  
Colon Cleansing ◽  
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.

scholarly journals Preparation regimen is more important than patient-related factors: a randomized trial comparing a standard bowel preparation before colonoscopy with an individualized approach

2017 ◽  
Vol 55 (1) ◽  
pp. 36-43 ◽  
Author(s):  
T. Voiosu ◽  
Alina Tanţău ◽  
A. Voiosu ◽  
Andreea Benguş ◽  
Cristina Mocanu ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Multivariable Analysis ◽  
Standard Group ◽  
Related Factors ◽  
Split Dose ◽  
Bowel Cleansing ◽  
Significant Difference ◽  
Bowel Prep

Abstract Background. Optimal bowel preparation is one of the most important factors affecting the quality of colonoscopy. Several patient-related factors are known to influence the quality of bowel cleansing but randomized trials in this area are lacking. We aimed to compare an individualized bowel prep strategy based on patient characteristics to a standard preparation regimen. Material and Methods. We conducted an endoscopist-blinded multicenter randomized control-trial. The Boston Bowel Prep Score (BBPS) was used to assess quality of bowel preparation and a 10 point visual analogue scale to assess patient comfort during bowel prep. Patients were randomised to either the standard regimens of split-dose 4L polyethylene-glycol (group A), split-dose sodium picosulphate/magnesium citrate (group B) or to either of the two depending on their responses to a 3-item questionnaire (individualized preparation, group C). Results. 185 patients were randomized during the study period and 143 patients were included in the final analysis. Patients in the individualized group had a median BBPS of 7 compared to a median of 6 in the standard group (p = 0.7). Also, there was no significant difference in patients’ comfort scores, irrespective of study group or laxative regimen. However, on multivariable analysis, a split-dose 4L polyethylene-glycol was an independent predictor for achieving a BBPS>6 (OR 3.7, 95% CI 1.4-9.8), regardless of patient-related factors. Conclusion. The choice of laxative seems to be more important than patient-related factors in predicting bowel cleansing. Comfort during bowel prep is not influenced by the type of strategy used.

scholarly journals Effectiveness in Bowel Cleansing and Patient Tolerability of Polyethylene Glycol versus Sodium Picosulphate in Patients Undergoing Colonoscopy

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Amit Kumar Jaiswal ◽  
Shatdal Chaudhary
Keyword(s):  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Lesion Detection ◽  
Open Label ◽  
Split Dose ◽  
Sodium Picosulphate ◽  
Bowel Cleansing ◽  
Colonic Preparation ◽  
Sodium Picosulfate ◽  
Structured Questionnaire

Introduction. Colonoscopy is considered as a gold standard investigation for screening of colorectal cancer and other lower gastrointestinal pathologies. Adequate bowel preparation is absolutely necessary for a fruitful colonoscopy. Various bowel cleansing agents are being used for his purpose. The aim of the present study was to compare the two bowel cleansing agents: a single dose of Polyethylene Glycol (PEG) solution and a split dose of Sodium Picosulfate (Na PICOSUL) tablet with regards to cleansing efficacy and tolerability among the patients scheduled for colonoscopy. Methods. It is an open-label hospital-based observational study. A total of sixty-four patients were grouped randomly into two groups of bowel cleansing agents that are PEG and Na PICOSUL during the study period between 1st December 2015 and 30th November 2016. Patients’ tolerability was evaluated using a structured questionnaire, and the bowel cleansing efficacy was evaluated using the Aronchick Bowel Preparation Scale (ABPS). Results. The group that received PEG solution was found to have better efficacy than that which received Na PICOSUL tablet (63.3% versus 29.4%, respectively, with a P value < 0.028) with excellent grade as per ABPS. The Na PICOSUL group was found better in terms of tolerability than the PEG group as nausea/vomiting was encountered significantly higher in the PEG group than in the Na PICOSUL group (43.3% versus 11.8%, respectively, with a P value < 0.01). Conclusions. Colonic preparation with a split dose of Na PICOSUL tablet was better tolerated than the evening before regimen of PEG solution. However, PEG solution was found to be more efficacious in bowel cleansing, but procedural performance and lesion detection were similar for both agents.

Simethicone improves bowel cleansing with low-volume polyethylene glycol: a multicenter randomized trial

Endoscopy ◽  
2017 ◽  
Vol 50 (04) ◽  
pp. 412-422 ◽  
Author(s):  
Shenghong Zhang ◽  
Danping Zheng ◽  
Jinping Wang ◽  
Jianwei Wu ◽  
Pingguang Lei ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Conventional Group ◽  
Intubation Time ◽  
Cecal Intubation ◽  
Adenoma Detection ◽  
Bowel Cleansing ◽  
Cecal Intubation Time ◽  
Low Volume ◽  
The Right

Abstract Background and study aims For bowel preparation, using a reduced volume of polyethylene glycol (PEG) solution without influencing its effectiveness would be preferable. While simethicone shows great potential as an adjunctive agent, data on its use are limited. We aimed to clarify whether simethicone added to low-volume PEG solution improved bowel cleansing. Patients and methods Consecutive adult patients registered for colonoscopy were recruited from seven medical centers in South China between 15 April and 15 July 2015 and prospectively randomized into two groups: 2 L PEG (conventional group) and 2 L PEG plus simethicone (simethicone group). The primary endpoint was the effectiveness of bowel cleansing according to the Boston Bowel Preparation Scale (BBPS). Secondary endpoints included cecal intubation time, adenoma detection rate (ADR), patient safety and compliance, and adverse events. Results We included 290 and 289 patients in the conventional and simethicone groups, respectively, for analysis. The proportion with acceptable bowel cleansing (BBPS ≥ 6) was significantly higher in the simethicone group than in the conventional group (88.2 % vs. 76.6 %; P < 0.001). The mean (SD) BBPS score was significantly lower in the conventional group (6.5 [1.8] vs. 7.3 [1.7]; P < 0.001), as was the bubble score (2.5 [0.7] vs. 2.8 [0.5]; P < 0.001). The average cecal intubation time was significantly shorter in the simethicone group (6.3 [3.1] vs. 7.5 [5.1] minutes; P < 0.001). The ADR in the right colon was higher in the simethicone group than in the conventional group (16.6 % vs. 10.3 %; P = 0.03). Safety and compliance, including the taste, smell, and dosage of PEG, were similar for both groups. Conclusions Simethicone added to low-volume PEG solution improves bowel-cleansing efficacy, with similar safety and compliance, shorter cecal intubation time, and higher ADR.

scholarly journals A randomized trial of split dose 3 L polyethylene glycol lavage solution, 2 L polyethylene glycol lavage combined with castor oil, and 1 L of polyethylene glycol lavage solution combined with castor oil and ascorbic acid for preparation for colonoscopy

2019 ◽  
Author(s):  
Xu Tian ◽  
Bing Shi ◽  
Xiao-Ling Liu ◽  
Hui Chen ◽  
Wei-Qing Chen
Keyword(s):  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Castor Oil ◽  
Efficacy And Safety ◽  
Split Dose ◽  
Patient’S Satisfaction ◽  
Patients Satisfaction ◽  
Adenoma Detection ◽  
Baseline Characteristics ◽  
Lavage Solution

Our aim was to evaluate efficacy and safety of 30mL CaO alone or plus Asc in bowel preparation before colonoscopy. Two hundred and forty six patients were allocated randomly to ingest 2L PEG with 30mL CaO, 1L PEG with 30mL CaO plus 5g Asc, or 3L PEG. We used Boston Bowel Preparation Scale (BBPS) to evaluate bowel preparation efficacy. We also determined other outcomes such as procedure time, polyp or adenoma detection rate and adverse events (AEs). Of 282 patients recruited, 36 were excluded. Groups were matched for baseline characteristics except weight (P = 0.020) and body mass index (BMI) (P = 0.003). Patient’s satisfaction were higher in 2L PEG-CaO (P = 0.016) and 1L PEG-CaO-Asc groups (P = 0·017). Patients’ compliance was 67.5%, 71.4% and 80.5% in 3L PEG, 2L PEG-CaO and 1L PEG-CaO-Asc groups (P = 0.014). Adequate bowel preparation rate was 75%, 78.57% and 53.66% in 3L PEG, 2L PEG-CaO and 1L PEG-CaO-Asc groups (P = 0.021). There were no differences in terms of remaining outcomes. Despite an increase in patients’ satisfaction and compliance, 1L PEG-CaO-Asc significantly decreased adequate bowel preparation rate. However, 2L PEG-CaO improved the patients' satisfaction and compliance and increased adequate bowel preparation rate.

scholarly journals 3 Liter Polyethylene Glycol is Not Inferior to The Standard Bowel Preparation in Chinese Population with Equal Efficacy: A Randomized, Controlled Trial

2021 ◽  
Author(s):  
Peng Cheng ◽  
Qing-qi Chen ◽  
Ju-yuan Li ◽  
Zheng Cheng ◽  
Dian-hua Guo ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Adverse Events ◽  
Bowel Preparation ◽  
Chinese Population ◽  
Controlled Trial ◽  
Chinese Patients ◽  
Procedure Time ◽  
Adenoma Detection ◽  
Bowel Cleansing

Abstract Background Ideal bowel cleansing regimens should be both effective and well tolerated. The European Society of Gastrointestinal Endoscopy recommends 4L Polyethylene Glycol (PEG) as the standard regimen for the bowel preparation (BP). This large volume of PEG ensures a better-quality bowel cleansing but might be poorly tolerated amongst the Chinese population given their different characteristics. The current study compared the 3L and 4L PEG with regard to their effectiveness, tolerability, and safety amongst Chinese patients to identify the better suitable bowel cleansing method for this population. Methods This study employed a prospective, observer-blinded, randomized and controlled design in a high-volume endoscopic center. Consecutive patients undergoing colonoscopy were randomly assigned (1:1) to the 3L-PEG or 4L-PEG group. The quality of bowel cleansing, procedure time, adenoma detection rate (ADR), patient tolerance, and adverse events were compared. Results A total of 330 patients were included in the study. The quality of the bowel cleansing (Boston Bowel Preparation Scale) for both the whole intestine and each segment showing no significant differences between the groups. No significant differences were present with regard to the procedure time or ADR. The incidences of adverse events such as nausea (P = 0.001) and bloating (P < 0.001)were significantly lower in the 3L-PEG group. Moreover, there was a significantly higher rate of satisfaction in 3L-PEG group than that of the 4L-PEG group (P = 0.009). Conclusions 3L-PEG bowel cleansing represents an optimal alternative to a 4L-PEG preparation for Chinese people, showing a similar efficacy and superior levels of satisfaction, acceptability, and safety amongst users. We recommend 3L PEG be the routine regimen in the clinical setting for Chinese patients. (ClinicalTrials.gov registration number: NCT03356015, registered in 29 November, 2017, https://www.clinicaltrials.gov/ct2/show/NCT03356015)

scholarly journals A134 A MULTI-CENTRE RANDOMIZED CONTROLLED TRIAL TO COMPARE TWO BOWEL CLEANSING REGIMENS AFTER A COLONOSCOPY WITH INADEQUATE BOWEL PREPARATION

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 118-119
Author(s):  
M Sey ◽  
D von Renteln ◽  
R Sultanian ◽  
C McDonald ◽  
M Martel ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Bowel Preparation ◽  
Task Force ◽  
Controlled Trial ◽  
Phase Iii ◽  
Advanced Adenoma ◽  
Adherence Rate ◽  
Split Dose ◽  
Randomized Controlled ◽  
Adenoma Detection

Abstract Aims Failed bowel preparation is common during colonoscopy, yet the optimal purgative regimen to use for the next attempt is unknown. The objective of this study was to compare the efficacy, tolerability, and safety of two regimens at supratherapeutic doses for use after failed bowel preparation. Methods A multi-centre phase III endoscopist blinded randomized controlled trial (NCT02976805) was conducted in patients who failed bowel preparation, using the US Multi-Society Task Force (USMSTF) definition of inability to exclude polyps &gt;5 mm in size and requiring a shortened interval to next colonoscopy. Regimen A consisted of 15 mg of bisacodyl and 2 + 2 L of split dose polyethylene glycol electrolyte solution (PEG) and Regimen B consisted of 15 mg of bisacodyl and 4 + 2 L of split dose PEG. The primary outcome was adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score ≥ 6 with all segment scores ≥ 2. Secondary outcomes were adequate bowel preparation using the USMSTF definition, median BBPS, adenoma detection (ADR), advanced adenoma detection (aADR), sessile serrated polyp detection (SSPDR), and cecal intubation (CIR). Adverse events were assessed at the time of the colonoscopy and 14 days later. Results Between February 2017 and December 2019, 250 subjects were screened at four academic centres in Canada, of which 195 were randomized: 96 to Regimen A and 99 to Regimen B. The mean (SD) age was 60.6 (11.4) years, 87 (45.1%) were female, and the median (IQR) total BBPS score at previous failed colonoscopy was 3 (1,4). Regimen B was not superior to Regimen A in achieving adequate bowel preparation using the BBPS definition (87.6% vs. 91.1%, p=0.45) or the USMSTF definition (85.4% vs 91.1%, p=0.24), nor was it superior with respect to the median BBPS score (7 vs 7, p=0.50), mean ADR (31.5% vs 37.8%, p=0.37), aADR (11.2% vs 18.9%, p=0.15), SSPDR (5.6% vs 8.9%, p=0.40) or CIR (92.1% vs 96.7%, p=0.19). Regimen A had a higher adherence rate (88.2% vs. 74.7%, p=0.02) and greater willingness to undergo the bowel preparation again (91.2% vs. 66.2%, p&lt;0.001). The only serious adverse event occurred in a patient randomized to Regimen B who was admitted to hospital for vomiting after colonoscopy. Conclusions Split dose 4L PEG with 15mg of bisacodyl is highly efficacious, well tolerated, and can be used for patients who previously failed first line bowel preparations. The additional 2L of PEG in Regimen B did not improve bowel preparation and was not as well tolerated. Funding Agencies AMOSO Opportunities Grant, Pharmascence Inc.

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