Comparison of efficacy and tolerance of low-volume preparations prior to colonoscopy a randomized trial.

2019 ◽  
Vol 98 (7) ◽  
pp. 277-281

Introduction: The aim of the study was to compare the efficacy and tolerability of polyethylene glycol/ascorbic acid (PEGA), sodium picosulfate/ magnesium citrate (SPMC) and the oral sulfate formula (SIR) in a single- or split-dose regimen for bowel preparation prior to colonoscopy. Methods: Randomised, multicentre, open-label study. The subjects received either PEGA, SPMC or SIR in the single- or split-dose regimen before the colonoscopy. Quality and tolerability of the preparation and complaints during preparation were recorded using a 5 point scale. Results: 558 subject were analysed. Preparation quality was comparable in the single-dose regimen. The rate of satisfactory bowel cleansing (Aronchick score 1+2) was higher for split-dose SIR and PEGA compared to SPMC (95.6%, 86.2% vs. 72.5%, p<0.028). The highest tolerance rate (score 1+2) was reported for SPMC (82.3%, p<0.003) and the lowest for single-dose SIR (34.8%, p=0.008). The lowest frequency of nausea (10.4%) was observed for SPMC. The highest prevalence of bloating was linked with the use of PEGA (34.0%). Conclusion: Differences in bowel preparation quality were apparent only in the split-dose regimen, with SIR rated as most efficient. SPMC was the best tolerated formula. The split-dose regimen is more effective than single-dose preparation used in the evening before the examination.

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Amit Kumar Jaiswal ◽  
Shatdal Chaudhary

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.


2017 ◽  
Vol 2017 ◽  
pp. 1-4
Author(s):  
Shi-gui Xue ◽  
Han-lin Chen ◽  
Chun-sheng Cheng ◽  
Bao-sheng Huang ◽  
Hou-de Zhang

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.


2016 ◽  
Vol 25 (3) ◽  
pp. 295-302 ◽  
Author(s):  
Christian Schulz ◽  
Joachim Müller ◽  
Joachim Sauter ◽  
Stephan Miehlke ◽  
Christoph Schmöcker ◽  
...  

Background & Aims: Split-dose regimens are generally recommended for bowel cleansers. However, other regimens still remain in the summary of product characteristics of some bowel cleansers in Europe. The aim of this study is to compare the efficacy and safety of a split-dose regimen of sodium picosulfate/magnesium citrate (SPMC) with a prior-day schedule (AM/PM). Methods: Multicenter, randomized (EudraCT no. 2013-001620-20), endoscopist-blinded, parallel study, carried out in subjects 18 years or older undergoing elective colonoscopy. The primary endpoint was the bowel cleansing assessment using a binary transformation (adequate/inadequate) of the Global Preparation Assessment (GPA) scale. Additional parameters analyzed were the segmental assessment of bowel cleansing (RSS), the adenoma detection rate and safety evaluations. Results: 315 subjects comprised the ITT set. A significantly higher proportion of patients in the split-dose regimen had an adequate bowel preparation (AM/PM: 30.8% vs split-dose: 79.9%; p<0.0001). The mean global RSS was significantly lower in the split-dose group (AM/PM: 5.0 [SD: 2.91] vs split-dose: 2.6 [SD: 2.14]; p<0.0001). Flat polyps were detected in a higher proportion of subjects in the split-dose group compared with the AM/PM group (AM/PM: 16.0% vs split-dose: 22.0%). Both regimens were equally safe and well tolerated, with no serious treatment-emergent adverse events or discontinuations due to adverse events. Conclusion: A split-dose regimen of SPMC is superior to the AM/PM regimen administered the day before colonoscopy. Split regimen of SPMC should be considered the standard of use. Abbreviations: CTCAE: Common Terminology Criteria for Adverse Events; eGFR: Glomerular filtration rate; mITT: modified intent-to-treat; RSS: Residual Stool Score; SA: safety analysis; SAE: serious adverse event; SmPC: summary of product characteristics; SPMC: sodium picosulfate-magnesium citrate.


2021 ◽  
Vol 104 (10) ◽  
pp. 1597-1603

Background: Colonoscopy is an effective surveillance for the diagnosis and screening of colorectal cancer (CRC). Prior to the procedure, people would take laxatives for a good visualization of bowel texture. Although a split-dose bowel preparation has become popular, many anesthesiologists are concerned about pulmonary aspiration. Objective: To study the gastric residual volume and pH in patients taking split-dose bowel preparation as compared to those having laxatives on the day before the procedure. Materials and Methods: One hundred patients were randomized equally into two groups, as A for a single-dose, and B for a split-dose regimen. All patients underwent endoscopy under standard anesthetic care. The total gastric residual volume was suctioned, and pH was measured through the endoscope. The surgical team was unaware of the study protocol. The quality of bowel cleansing was assessed by the endoscopist using the Boston Bowel Preparation Scale (BBPS). Results: The bowel cleansing, the latency period, the endoscopist and patients’ satisfaction of single-and split-dose group were 7.06±1.4 and 8.14±1.1, 13.3±1.1 and 4.2±0.4 hours, 62.0% and 94.0%, and 90.0% and 74.0%, respectively. They all showed statistically significant differences between the two groups (p<0.05). Conclusion: The gastric residual volume and pH were not different between the split and single-dose preparations. Therefore, it might not increase the risk of aspiration pneumonitis. However, the split-dose technique was more effective in colon cleansing, patients’ tolerability, acceptability, and compliance than the preparations administered entirely the day or evening before the surgical procedure. Keywords: Gastro-colonoscopy; Single-dose bowel preparation; Split-dose bowel preparation; Gastric residual volume; Anesthesia


2020 ◽  
Author(s):  
Tegegne Eshetu ◽  
Mulugeta Aemero ◽  
Ayalew Jejaw

Abstract Background: Despite the existence of a population-based control program using single dose albendazole or mebendazole as a preventive chemotherapy, hookworm transmission remains high. It causes a negative impact on the growth and school performance of children. In connection to this preventive chemotherapy, different studies produced conflicting results. This study aimed at evaluating the efficacy of single (500mg) versus multiple doses (100mg twice a day during three consecutive days) of mebendazole against hookworm infections among school-aged children. Methods: This randomized open-label clinical trial took place among school-aged children (6-14 years old) in Burie and Debre Elias towns, Northwest Ethiopia. Using simple randomization, eligible hookworm-positive children were allocated (1:1) to either a single or multiple dose treatment arms. Stool samples were collected and processed using McMaster method at baseline and follow-up period (14-21 days after treatment). Only laboratory technicians were blinded. The cure and egg reduction rates which were assessed after 14-21 days of treatment were the primary and secondary therapeutic outcome measures against hookworm infections, respectively. An independent t-test was used to compare group means, and logistic regression was used to calculate odds ratio (OR). P-value < 0.05 at 95% CI was considered statistically significant. Result: 108 children, 54 in each treatment arm had completed baseline data and received allocated treatment. 103 children had completed follow-up data records and included for the final efficacy analysis. Cure rate against hookworm was significantly higher in the multiple dose (96.1%) than in the single dose (30.8%) with OR=55.125; 95% CI: 11.92-254.9; P < 0.001. The egg reduction rate in the multiple dose treatment arm (99.5%) was also significantly higher than in the single dose arm (68.9%) with difference t (101) =5.38; 95% CI 230.95-505.36; P < 0.001. Conclusion: The single dose regimen of mebendazole for the treatment of hookworm infections showed poor cure and egg reduction rates, while the multiple dose revealed satisfactory. Although multiple dose regimen administration is a bit more complex than the single dose, we strongly encourage replacing it with multiple dose regimen during deworming programs in hookworm endemic areas. Trial registration: This trial is registered in www.pactr.org, # PACTR201911466695052.


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