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

2020 ◽  
Vol 21 (11) ◽  
pp. 844-849 ◽  
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.

scholarly journals The importance of colonoscopy bowel preparation for the detection of colorectal lesions and colorectal cancer prevention

2020 ◽  
Vol 08 (05) ◽  
pp. E673-E683 ◽  
Author(s):  
Prateek Sharma ◽  
Carol A. Burke ◽  
David A. Johnson ◽  
Brooks D. Cash
Keyword(s):  
Colorectal Cancer ◽  
Bowel Preparation ◽  
Clinical Importance ◽  
High Volume ◽  
High Quality ◽  
Crc Screening ◽  
Incidence And Mortality ◽  
Low Volume ◽  
Split Dosing ◽  
Bowel Preparations

Abstract Background and study aims Colonoscopy for colorectal cancer (CRC) screening has reduced CRC incidence and mortality and improved prognosis. Optimal bowel preparation and high-quality endoscopic technique facilitate early CRC detection.This review provides a narrative on the clinical importance of bowel preparation for colonoscopy and highlights available bowel preparations. Methods A PubMed search was conducted through June 2019 to identify studies evaluating clinical outcomes, efficacy, safety, and tolerability associated with bowel preparation for CRC screening-related colonoscopy. Results Selecting the optimal bowel preparation regimen is based on considerations of efficacy, safety, and tolerability, in conjunction with individual patient characteristics and preferences. Available bowel preparations include high-volume (4 L) and low-volume (2 L and 1 L), polyethylene glycol (PEG) solutions, sodium sulfate, sodium picosulfate/magnesium oxide plus anhydrous citric acid, sodium phosphate tablets, and the over-the-counter preparations magnesium citrate and PEG-3350. These preparations may be administered as a single dose on the same day or evening before, or as two doses administered the same day or evening before/morning of colonoscopy. Ingesting at least half the bowel preparation on the day of colonoscopy (split-dosing) is associated with higher adequate bowel preparation quality versus evening-before dosing (odds ratio [OR], 2.5; 95 % confidence interval [CI], 1.9−3.4). Conclusions High-quality bowel preparation is integral for optimal CRC screening/surveillance by colonoscopy. Over the last 30 years, patients and providers have gained more options for bowel preparation, including low-volume agents with enhanced tolerability and cleansing quality that are equivalent to 4 L preparations. Split-dosing is preferred for achieving a high-quality preparation.

scholarly journals A2 THE BOWEL CLEANSING NATIONAL INITIATIVE (BCLEAN): PREDICTORS OF INADEQUATE BOWEL PREPARATION

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 2-3
Author(s):  
A N Barkun ◽  
M Martel ◽  
I L Epstein ◽  
P Hallé ◽  
R J Hilsden ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Bowel Preparation ◽  
High Volume ◽  
Random Allocation ◽  
Charlson Score ◽  
Split Dose ◽  
Bowel Cleansing ◽  
Low Residue Diet ◽  
Low Volume ◽  
Inadequate Bowel Preparation

Abstract Background Adequate bowel cleansing before colonoscopy is, in theory, a simple concept but the high rate of inadequate or incomplete bowel cleanliness and its consequences have been the subject of many studies, guidelines, and meta- analyses. The complexity resides in all the pre-endoscopic factors surrounding preparation intake that may? influence quality of the bowel preparation. Aims To identify preendoscopic variables associated with inadequate bowel preparation Methods In this randomized trial conducted in adult outpatients in 10 Canadian hospitals, all early morning (AM) colonoscopies were scheduled between 7h30AM and 10h30AM and patients were randomized to PEG low volume or high- volume split-dose or high- volume day before. Later colonoscopies (PM) were scheduled between 10h30AM and 16h30PM and patients were randomized to PEG low-volume or high- volume split-dose or low- volume same day. A secondary random allocation assigned patients to a clear fluid or low residue diet. Inadequate bowel preparation was identified on the Boston Bowel Preparation Scale with a total score <6 with any of the 3 colonic segments subscores <2). All preendoscopic variables such as patients related factors, diet and type of bowel preparation were evaluated between groups with chi-square, Fisher’s exact or t-test where appropriate. All variables found to be significantly associated with a clean preparation on univariable analysis at the P=0.15 level were used to construct a multivariable model. Because of stratified randomization by time with possible resulting differing confounders, AM and PM patients were analysed separately. Results Over 29 months, 1726 patients were stratified in the AM group and 1750 patients in the PM group. 16.9% had inadequate bowel preparation in the AM group and 9.8% in the PM group. Pre-endoscopic variables associated with an inadequate bowel cleanliness in AM colonoscopy were a non screening indication (OR 1.36, 95%CI 1.04–1.78), a Charlson score>0 (OR 1.36, 95% 1.03–1.80) and a low residue diet (OR 1.53, 95%CI 1.17–2.01). Amongst PM colonoscopies, variables associated with an inadequate bowel cleanliness were increased age (OR 1.03, 95% 1.01–1.04), a non screening indication (OR 1.90 95%CI 1.35–2.70); a Charlson score>0 (OR 1.63, 95%CI 1.15–2.32), and a low residue diet (OR 1.41, 95%CI 1.01; 1.98). Conclusions In this large randomized trial, amongst patients undergoing an AM colonoscopy, pre- endoscopic factors associated with an inadequate bowel preparation were a non screening indication, comorbidities and a low residue diet. Amongst PM colonoscopy patients, in addition to these variables, an increased age was also associated with an inadequate bowel preparation. Funding Agencies received arm-length funding from Pendopharm Inc.

scholarly journals 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

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.

Low-volume PEG plus ascorbic acid versus high-volume PEG as bowel preparation for colonoscopy

2010 ◽  
Vol 45 (11) ◽  
pp. 1380-1386 ◽  
Author(s):  
Sietske Corporaal ◽  
Jan H. Kleibeuker ◽  
Jan J. Koornstra
Keyword(s):  
Ascorbic Acid ◽  
Bowel Preparation ◽  
High Volume ◽  
Acid Versus ◽  
Low Volume

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

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
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).

scholarly journals Stratification of Prognoses based on Criteria from Clinical Trials of Metastatic Hormone-sensitive Prostate Cancer

2021 ◽  
Author(s):  
Hyun Kyu Ahn ◽  
Jeong Woo Yoo ◽  
Kyo Chul Koo ◽  
Byung Ha Chung ◽  
Kwang Suk Lee
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Liver Metastasis ◽  
Bone Metastasis ◽  
High Volume ◽  
Classification Systems ◽  
Oncologic Outcomes ◽  
Visceral Metastasis ◽  
Hormone Sensitive ◽  
Low Volume

Abstract Background: Oncologic outcomes in metastatic hormone-sensitive prostate cancer (mHSPC) are extremely heterogeneous. We aimed to (1) stratify the prognosis in mHSPC patients according to criteria for high-volume disease, as defined in clinical trials, and (2) identify the combinations of unfavorable risk factors.Methods: This retrospective study reviewed 623 patients who were diagnosed with mHSPC between 1996 and 2014. The prognoses of mHSPC patients were stratified by criteria from the GETUG15, CHAARTED, STAMPEDE, and LATITUDE trials. The exclusion criteria were incomplete clinical data, docetaxel chemotherapy with upfront options, and metastatic disease without proper management after initial diagnosis.Results: All 485 patients (median follow-up=36.1 months) were categorized according to stage: M1a (70, 14.4%), M1b (367, 75.7%), and M1c (48, 9.9%). Significant differences in overall survival (OS) and cancer-specific survival (CSS) were found among the groups with low-volume disease, as classified by four clinical trials (log-rank p=0.001 and p<0.001, respectively). Bone metastasis volume and liver metastasis were independent predictors of prognosis. According to disease classification under NCCN guidelines, the prognosis of CSS between low-volume disease patients and M1c patients (no bone metastasis and low-volume bone metastasis) was not significantly different. Additionally, the prognosis of CSS did not significantly differ between M1c (high-volume bone metastasis and visceral metastasis, except liver) and M1b (high-volume bone metastasis) patients.Conclusions: The prognoses of patients with low-volume disease, based on several classification systems, were heterogeneous. Except for lung or liver metastasis, the combination of visceral metastasis with no/low-volume bone disease should be considered as a proxy of less aggressive disease in patients presenting with mHSPC.

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