Bowel cleansing efficacy for colonoscopy: prospective, randomized comparative study of same-day dosing with 1-L and 2-L PEG + ascorbate

Abstract Background and study aims Polyethylene glycol (PEG) bowel preparations are effective but associated with high ingestion volume. In this study, 1-L PEG and 2-L PEG preparations were compared in a randomized, colonoscopist-blinded, single-center trial. Patients and methods Patients were aged > 18 years, required colonoscopy, and provided informed consent. Randomization was 1:1 to 1-L PEG or 2-L PEG, based on hospital identification number (odd or even). Preparations were administered using same-day dosing adjusted for colonoscopy start time. The primary endpoint was successful bowel preparation on the Boston Bowel Preparation Scale (BBPS) (no segment scored < 2). Results A total of 852 patients were randomized. In the intention-to-treat (ITT) population, significantly more patients had diabetes in the 2-L PEG arm, resulting in the creation of the modified-ITT population (mITT) that excluded diabetic patients to correct the imbalance (1-L PEG, n = 239; 2-L PEG, n = 238). In the mITT, there was no significant difference in successful cleansing between 1-L PEG and 2-L PEG (88.3 % vs. 82.4 %; P = 0.067). Excellent cleansing (BBPS 7–9; no segment < 2) was significantly improved with 1-L PEG (60.7 % vs. 50.4 %; P < 0.024), as were mean scores in the right and left colon (right: 2.47 vs. 2.30; P < 0.008; left: 2.55 vs. 2.39; P = 0.008). Adverse events were mild to moderate in intensity and none resulted in discontinuation. Rates of nausea and vomiting were significantly higher with 1-L PEG, but that did not affect successful cleansing. Conclusions The lower-volume 1-L PEG was associated with higher levels of excellent bowel cleansing and greater mean segmental scores on the BBPS than 2-L PEG.

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Educational nurse-led telephone intervention shortly before colonoscopy as a salvage strategy after previous bowel preparation failure: a multicenter randomized trial

Endoscopy ◽

10.1055/a-1178-9844 ◽

2020 ◽

Vol 52 (11) ◽

pp. 1026-1035 ◽

Cited By ~ 1

Author(s):

Marco Antonio Alvarez-Gonzalez ◽

Miguel Ángel Pantaleón Sánchez ◽

Belén Bernad Cabredo ◽

Ana García-Rodríguez ◽

Santiago Frago Larramona ◽

...

Keyword(s):

Bowel Preparation ◽

Protocol Analysis ◽

Controlled Trial ◽

Intervention Group ◽

Telephone Intervention ◽

Intention To Treat ◽

Bowel Cleansing ◽

Significant Difference ◽

Inadequate Bowel Preparation ◽

And Control

Background The most important predictor of unsuccessful bowel preparation is previous failure. For those patients with previous failure, we hypothesized that a nurse-led educational intervention by telephone shortly before the colonoscopy appointment could improve cleansing efficacy. Methods We performed a multicenter, endoscopist-blinded, randomized controlled trial. Consecutive outpatients with previous inadequate bowel preparation were enrolled. Both groups received the same standard bowel preparation protocol. The intervention group also received reinforced education by telephone within 48 hours before the colonoscopy. The primary outcome was effective bowel preparation according to the Boston Bowel Preparation Scale. Intention-to-treat (ITT) analysis included all randomized patients. Per-protocol analysis included patients who could be contacted by telephone and the control cases. Results 657 participants were recruited by 11 Spanish hospitals. In the ITT analysis, there was no significant difference between the intervention and control groups in the rate of successful bowel preparation (77.3 % vs. 72 %; P = 0.12). In the intervention group, 267 patients (82.9 %) were contacted by telephone. Per-protocol analysis revealed significantly improved bowel preparation in the intervention group (83.5 % vs. 72.0 %; P = 0.001). Conclusion Among all patients with previous inadequate bowel preparation, nurse-led telephone education did not result in a significant improvement in bowel cleansing. However, in the 83 % of patients who could be contacted, bowel preparation was substantially improved. Phone education may therefore be a useful tool for improving the quality of bowel preparation in those cases.

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A Prospective Randomized Controlled Trial of AJG522 versus Standard PEG + E as Bowel Preparation for Colonoscopy

BioMed Research International ◽

10.1155/2015/521756 ◽

2015 ◽

Vol 2015 ◽

pp. 1-8 ◽

Cited By ~ 4

Author(s):

Toshihiko Sagawa ◽

Ken Sato ◽

Taku Tomizawa ◽

Masafumi Mizuide ◽

Hidetoshi Yasuoka ◽

...

Keyword(s):

Bowel Preparation ◽

Controlled Trial ◽

Bowel Function ◽

Liquid Volume ◽

Randomized Controlled ◽

Stimulant Laxative ◽

Bowel Cleansing ◽

Prospective Randomized Controlled Trial ◽

Bowel Preparations ◽

To Receive

Polyethylene glycol- (PEG-) based bowel preparations for colonoscopies are often poorly tolerated due to the large volumes of fluid intake required. We compared low-volume “modified” PEG + ascorbic acid (AJG522) with standard PEG with electrolytes (PEG + E) in addition to a stimulant laxative and an agent to improve bowel function for the bowel cleansing before colonoscopy to evaluate its efficacy, safety, and acceptability. Outpatients scheduled to undergo colonoscopy were randomized to receive either AJG522 or PEG + E. Bowel cleansing conditions were assessed via macroscopic fecal findings by blinded and independent investigators. A survey of the patients’ feedback regarding the preparation was conducted by questionnaire. Successful cleansing was achieved in all cases, except for 4 cases in the PEG + E group, at 3 hours after taking the preparation. The fecal properties were significantly clearer in the AJG522 group than in the PEG + E group at 2 hours after taking each preparationP=0.013. Although the total liquid volume of the bowel preparation was not reduced, the AJG522 preparation could significantly reduce the required volume of the preparationP<0.0001. Moreover, the patients in the AJG522 group had better acceptabilityP=0.010. There were no significant differences in the safety profiles between groups (UMIN000013892).

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New Ultra Low Volume Bowel Preparation and Overview of Existing Bowel Preparations

Current Drug Metabolism ◽

10.2174/1567201817666200810112136 ◽

2020 ◽

Vol 21 (11) ◽

pp. 844-849 ◽

Cited By ~ 1

Author(s):

Hein Htet ◽

Jonathan Segal

Keyword(s):

Clinical Trials ◽

Side Effects ◽

Bowel Preparation ◽

High Volume ◽

Extensive Literature ◽

Electrolyte Disturbances ◽

Bowel Cleansing ◽

Bowel Prep ◽

Low Volume ◽

Bowel Preparations

Background: Adequate bowel cleansing is essential in achieving a good quality colonoscopy. However, one of the barriers to achieving high-quality bowel cleansing is the patient's tolerability. Different bowel preparations have been developed to improve tolerability while maintaining adequate bowel cleansing. Objectives: We aim to explore the pros and cons of commonly used bowel preparations, particularly highlighting the new ultra-low volume bowel preparation. Methods:: Extensive literature search was carried out on various databases to evaluate the effectiveness and side effects of different bowel cleansing agents, including findings of recent clinical trials on ultra-low bowel preparation. Results:: Polyethylene glycol (PEG) has been commonly used as a bowel prep. Due to its high volume required to ingest to achieve an adequate effect, it has been combined with various adjuncts to reduce the volume to make it more tolerable. Magnesium and phosphate-based preps can achieve low volume, but they can be associated with multiple side effects, mainly electrolyte disturbances. Ultra low volume prep (NER1006) was achieved by combing PEG with ascorbic acid, and its efficacy and side effects were demonstrated in three noninferiority studies. Conclusion: It is important to consider patient preferences, co-morbidities and tolerability, and efficacy and side effect profiles when choosing bowel prep for patients undergoing colonoscopy. New ultra-low bowel prep showed promising results in initial clinical trials, but further real-world post-marketing data will inform its value in clinical practice.

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Comparison of Polyethylene Glycol versus Lactulose Oral Solution for Bowel Preparation prior to Colonoscopy

Gastroenterology Research and Practice ◽

10.1155/2019/2651450 ◽

2019 ◽

Vol 2019 ◽

pp. 1-6 ◽

Cited By ~ 1

Author(s):

Chun-Xia Li ◽

Yan Guo ◽

Yang-Jie Zhu ◽

Jian-Ru Zhu ◽

Qian-Song Xiao ◽

...

Keyword(s):

Polyethylene Glycol ◽

Bowel Preparation ◽

Oral Solution ◽

Physician Satisfaction ◽

Detection Rates ◽

Bowel Cleansing ◽

Degree Of Satisfaction ◽

Bowel Preparations ◽

Colonoscopy Preparation

Objective. This study was conducted to compare a lactulose oral solution with a polyethylene glycol (PEG) formulation for colonoscopy preparation using the following metrics: quality of cleansing, colonoscopy outcomes, patient/physician satisfaction, and patient tolerability. Methods. The enrolled patients were randomly divided into two groups and received a single 2 L dose of either PEG (PEG group) or lactulose (Lac group). The Boston Bowel Preparation Scale (BBPS) was used for assessing the cleansing quality of the bowel preparations. Patient tolerability and adverse events were obtained through the completion of questionnaires. Results. The lactulose oral solution showed superior bowel cleansing compared to PEG, as evidenced by higher BBPS scores in the Lac group for all segments of the colon (P<0.05). The detection rates of polyps and intestinal lesions in the Lac group (30.68% and 36.36%, respectively) were significantly higher than those in the PEG group (12.50% vs. 13.63%, respectively). For the degree of satisfaction, the Lac group had significantly higher scores compared to the PEG group, as evaluated by both the patients and endoscopist. PEG was associated with an increased incidence of nausea. There were no statistical differences between the groups in terms of vomiting, abdominal pain or fullness, dizziness, unfavorable palatability, dry mouth, palpitation, tinnitus, and tongue numbness. Conclusion. A single 2 L dose of a lactulose oral solution had higher efficacy, improved tolerability, and acceptable safety for bowel preparation when compared to the same volume of PEG. Thus, a lactulose oral solution may be a potential bowel-cleansing option for colonoscopy preparation.

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Frequency of hyponatremia caused by sodium picosulfate solution when used as a bowel cleansing agent for colonoscopy

Pakistan Journal of Medical Sciences ◽

10.12669/pjms.36.7.2376 ◽

2020 ◽

Vol 36 (7) ◽

Author(s):

Tazeen Rasheed ◽

Haris Alvi ◽

Majid Ahmed Shaikh ◽

Faiza Sadaqat Ali ◽

Bader Faiyaz Zuberi ◽

...

Keyword(s):

Bowel Preparation ◽

Serum Sodium ◽

Sodium Level ◽

Serum Sodium Level ◽

Creative Commons ◽

Bowel Cleansing ◽

Two Samples ◽

Significant Difference ◽

Sodium Picosulfate ◽

The Difference

Objective: To determine the frequency of hyponatremia in patients taking Sodium Picosulfate Solution (SPS) solution for bowel preparation prior to colonoscopy and to compare serum sodium levels before and after SPS. Methods: This interventional study was conducted at Dr. Ruth K. M. Pfau, Civil Hospital Karachi between June 2019 to November 2019. Patients undergoing colonoscopy were included in the study. All patients were given SPS. Two samples of blood for electrolytes were taken, one 30 minutes before taking SPS solution and another 30 minutes before colonoscopy. Paired sample t-test was used to determine the difference between serum sodium level before taking the colonoscopy solution and serum sodium level before colonoscopy. Results: Fifty- four patients fulfilling inclusion criteria were included. Out of the 54 patients 28 (51.9%) were males and 26 (48.1%) were females. Mean sodium levels before taking colonoscopy solution was 139.7±3.5 mEq/L and mean sodium level before colonoscopy was 138.9±3.8 mEq/L. The difference between serum sodium level before taking SPS colonoscopy solution and before colonoscopy was found to be statistically insignificant (t (53) = 1.308; p = 0.196). Conclusion: No serious adverse effects were reported in any of our patients. There was no significant difference in the serum sodium level of patients undergoing colonoscopy before taking SPS bowel preparation solution and serum sodium level before colonoscopy. doi: https://doi.org/10.12669/pjms.36.7.2376 How to cite this:Rasheed T, Alvi H, Shaikh MA, Ali FS, Zuberi BF, Subhan W. Frequency of hyponatremia caused by sodium picosulfate solution when used as a bowel cleansing agent for colonoscopy. Pak J Med Sci. 2020;36(7):---------. doi: https://doi.org/10.12669/pjms.36.7.2376 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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A Multicentre, Observational Study of Sodium Picosulfate and Magnesium Citrate as a Precolonoscopy Bowel Preparation

Canadian Journal of Gastroenterology ◽

10.1155/2009/385619 ◽

2009 ◽

Vol 23 (10) ◽

pp. 706-710 ◽

Cited By ~ 19

Author(s):

Jonathan Love ◽

Edmond-Jean Bernard ◽

Alan Cockeram ◽

Lawrence Cohen ◽

Martin Fishman ◽

...

Keyword(s):

Observational Study ◽

Bowel Preparation ◽

Left Colon ◽

Preliminary Evaluation ◽

Magnesium Citrate ◽

Patient Acceptability ◽

Bowel Cleansing ◽

Sodium Picosulfate ◽

The Right ◽

Colonoscopy Preparation

BACKGROUND: Sodium picosulfate with magnesium citrate (PSMC) has been available as a precolonoscopy bowel preparation in Canada since 2005. A high patient acceptability and preference appears to have contributed to its wide adoption across the country. Despite its frequent use, there are relatively few published studies of this product, especially reports regarding its use in routine clinical practice. Moreover, to date, there have been no Canadian studies of any kind.OBJECTIVE: To conduct a preliminary evaluation of PSMC by prospectively collecting data describing its effectiveness.METHODS: In the present multicentre, observational study, sequential patients used PSMC according to each institution’s standard colonoscopy protocol. Differences in bowel cleansing protocols included dose timing, fluid intake, dietary restrictions and administration of bisacodyl. During colonoscopy, preparation quality was rated separately for the right and left sides of the colon.RESULTS: Of the 613 patients entered, 606 were evaluable for efficacy. For the right and left colon, respectively, 93.0% and 96.2% of preparations were rated either ‘excellent’ or ‘adequate’. In the 334 patients who received adjunctive bisacodyl and the 272 patients who did not, the results were similar: for the right and left colon, 92.3% and 97.1% of those who did not, and 93.4% and 95.7% of those who did receive bisacodyl, respectively, were rated either ‘excellent’ or ‘adequate’.CONCLUSIONS: Despite the differences in bowel cleansing protocols used at each hospital (including an additional laxative), PSMC consistently yielded a high percentage of positive ratings for efficacy.

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

Romanian Journal of Internal Medicine ◽

10.1515/rjim-2016-0047 ◽

2017 ◽

Vol 55 (1) ◽

pp. 36-43 ◽

Cited By ~ 1

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.

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

Endoscopy ◽

10.1055/s-0043-121337 ◽

2017 ◽

Vol 50 (04) ◽

pp. 412-422 ◽

Cited By ~ 17

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.

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The effects of a personalized smartphone application on bowel preparation quality: A randomized controlled trial (Preprint)

10.2196/preprints.26703 ◽

2020 ◽

Author(s):

Quirine Eunice Wennie van der Zander ◽

Ankie Reumkens ◽

Bas van de Valk ◽

Bjorn Winkens ◽

Ad AM Masclee ◽

...

Keyword(s):

Patient Satisfaction ◽

Bowel Preparation ◽

Controlled Trial ◽

Smartphone Application ◽

Control Group ◽

Right Colon ◽

Face To Face ◽

Written Information ◽

Significant Difference ◽

The Right

BACKGROUND Adequate bowel preparation is essential for visualization of the colonic mucosa during colonoscopy. OBJECTIVE Aim of this study was to compare instructions provided via a personalized smartphone application with regular written instructions for bowel preparation in improving bowel preparation quality, and to evaluate patient satisfaction concerning the bowel preparation procedure. METHODS Eligible patients scheduled for an outpatient colonoscopy were randomized to the smartphone application or control group. Both groups received identical face-to-face education from a research physician including instructions about the colonoscopy procedure, diet restrictions, and intake of the laxative. In addition, the control group received written information, whereas the smartphone application group was instructed to use the smartphone application instead of the written information. All patients used bisacodyl and sodium picosulfate with magnesium citrate as laxative. Quality of bowel preparation was scored using the Boston Bowel Preparation Scale by blinded endoscopists. Patient satisfaction was measured by the patient satisfaction questionnaire-18 (PSQ-18). RESULTS In total 87 patients participated in the smartphone application group and 86 in the control group. The mean total Boston bowel preparation scale was significantly higher in the smartphone application group (8.3±0.9) compared to the control group (7.9±1.2, P=.03). The right colon showed a significantly higher bowel preparation score in the smartphone application group (2.7±0.5 vs 2.5±0.6, P=.04). General patient satisfaction was high for the smartphone application group (4.4±0.7), but showed no significant difference compared to the control group (4.3±0.8, P=.32). CONCLUSIONS Our personalized smartphone application significantly improved bowel preparation quality, in particular in the right colon, but does not further improve patient satisfaction compared to patients receiving regular written instructions. CLINICALTRIAL ClinicalTrials.gov NCT03677050; https://clinicaltrials.gov/ct2/show/NCT03677050

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An Enhanced High-Volume Preparation for Colonoscopy Is Not Better Than a Conventional Low-Volume One in Patients at Risk of Poor Bowel Cleansing: A Randomized Controlled Trial

Frontiers in Medicine ◽

10.3389/fmed.2021.654847 ◽

2021 ◽

Vol 8 ◽

Author(s):

Antonio Z. Gimeno-García ◽

Goretti Hernández ◽

José Luis Baute Dorta ◽

Cristina Reygosa ◽

Raquel de la Barreda ◽

...

Keyword(s):

Clinical Trial ◽

Bowel Preparation ◽

Controlled Trial ◽

High Volume ◽

Risk Difference ◽

Predictive Score ◽

Clinical Trial Registration ◽

Intention To Treat ◽

Bowel Cleansing ◽

Low Volume

Objective: We tested the hypothesis that an enhanced bowel preparation strategy (EBS) improves colonic cleansing in patients at high risk for inadequate bowel cleansing (HRI).Methods: This prospective randomized clinical trial included consecutive HRI patients referred for outpatient colonoscopy between February and October 2019. HRI was considered if patients scored >1.225 according to a previously validated bowel-cleansing predictive score. HRI patients were randomized (1:1) to a low-volume conventional bowel cleansing strategy (CBS) (1-day low residue diet (LRD) plus 2 L of polyethylene glycol (PEG) plus ascorbic acid) or to an EBS (3-day LRD plus 10 mg oral bisacodyl plus 4 L PEG). The Boston Bowel Preparation Scale (BBPS) was used to assess the quality of cleanliness. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. A sample size of 130 patients per group was estimated to reach a 15% difference in favor of EBP.Results: A total of 253 HRI patients were included (mean age 69.8 ± 9.5 years, 51.8% women). No statistically significant differences were found in the BBPS scale between the two groups in the ITT analysis (CBS 76.8% vs. EBS 79.7%, P = 0.58) or PP analysis (CBS 78% vs. EBS 84.3%, P = 0.21), risk difference 2.9% (95% CI−7.26 to 39.16) in the ITT analysis, or risk difference 6.3% (95% CI−3.48 to 16.08) in PP analysis. No differences in preparation tolerance, compliance, adverse effects, or colonoscopy findings were found.Conclusion: EBS is not superior to CBS in hard-to-prepare patients. (EUDRACT: 2017-000787-15, NCT03830489).Clinical Trial Registration:www.ClinicalTrials.gov, identifier NCT03830489.

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