Impact of a 1-day versus 3-day low-residue diet on bowel cleansing quality before colonoscopy: a randomized controlled trial

Endoscopy ◽  
2019 ◽  
Vol 51 (07) ◽  
pp. 628-636 ◽  
Author(s):  
Antonio Z. Gimeno-García ◽  
Raquel de la Barreda Heuser ◽  
Cristina Reygosa ◽  
Alberto Hernandez ◽  
Isabel Mascareño ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Dietary Recommendations ◽  
Detection Rates ◽  
Split Dose ◽  
Intention To Treat ◽  
Level Of Satisfaction ◽  
Adenoma Detection ◽  
Bowel Cleansing ◽  
Low Residue Diet

Abstract Background The aim of this study was to assess whether a 3-day low-residue diet (LRD) improved bowel cleansing quality compared with a 1-day LRD regimen. Methods Consecutive patients scheduled for outpatient colonoscopy were randomized to the 1-day LRD or 3-day LRD groups. All patients received a 2-L split-dose of polyethylene glycol plus ascorbic acid. The primary outcome was bowel cleansing quality as evaluated using the Boston Bowel Preparation Scale (BBPS) (adequate cleansing ≥ 2 points per segment). Secondary outcomes were adherence to and level of satisfaction with the LRD, difficulty following the dietary recommendations, and willingness to repeat the same LRD in the future. Intention-to-treat (ITT) and per-protocol (PP) analyses were conducted for the primary outcome. A superiority analysis was performed to demonstrate that a 3-day LRD regimen was superior to a 1-day LRD regimen with a margin of 10 %. Results 390 patients (1-day LRD group = 196, 3-day LRD = 194) were included. The cleansing quality was not significantly different between the groups: ITT analysis 82.7 % (95 % confidence interval [CI] 77.4 to 88.0) vs. 85.6 % (95 %CI 80.7 to 90.5), with odds ratio (OR) 1.2 (95 %CI 0.72 to 2.15); PP analysis 85.0 % (95 %CI 79.9 to 90.1) vs. 88.6 % (95 %CI 84.0 to 93.2), with OR 1.4 (95 %CI 0.88 to 2.52). No differences were found regarding adherence to the diet or cleansing solution, satisfaction or difficulty with the LRD, and the polyp/adenoma detection rates. Conclusion 3-day LRD did not offer advantages over 1-day LRD in preparation for colonoscopy.

scholarly journals Efficacy and Patient Tolerability Profiles of Probiotic Solution with Bisacodyl Versus Conventional Cleansing Solution for Bowel Preparation: A Prospective, Randomized, Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3286
Author(s):  
Youn I Choi ◽  
Jong-Joon Lee ◽  
Jun-Won Chung ◽  
Kyoung Oh Kim ◽  
Yoon Jae Kim ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Detection Rate ◽  
Controlled Trial ◽  
Screening Colonoscopy ◽  
Control Group ◽  
Case Group ◽  
Detection Rates ◽  
Polyp Detection Rate ◽  
Adenoma Detection ◽  
Bowel Cleansing

Although adequate bowel preparation is essential in screening colonoscopy, patient intolerability to bowel cleansing agents is problematic. Recently, a probiotic mixture solution with bisacodyl emerged to improve patient tolerability. We investigated the efficacy, safety, and patient tolerability profiles of probiotics with bisacodyl versus conventional polyethylene glycol (PEG) solution for bowel preparation for screening colonoscopies in healthy patients in this prospective, randomized, case-control study. In total, 385 volunteers were randomly assigned to receive 2 L of water + 200 mL of probiotic solution (case group, n = 195) or 4 L of PEG solution (control group, n = 190). The efficacy of the bowel cleansing was evaluated using the Ottawa scale system, polyp detection rate, and adenoma detection rate, and the patient tolerability profiles were assessed using a questionnaire. The demographics were not significantly different between groups. When the Ottawa score for each bowel segment was stratified into an adequate vs. inadequate level (Ottawa score ≤ 3 vs. >3), there were no statistical differences between groups in each segment of the colon. There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42, p = 0.30; 25.79% vs. 18.97%, p = 0.11). The case group showed significantly fewer events than the control group, especially nausea, vomiting, and abdominal bloating events. Regarding the overall satisfaction grade, the case group reported significantly more “average” scores (95% vs. 44%, p < 0.001) and were more willing to use the same agents again (90.26% vs. 61.85%, p < 0.001). As patient compliance with bowel preparation agents is associated with an adequate level of bowel cleansing, a probiotic solution with bisacodyl might be a new bowel preparation candidate, especially in patients who show a poor compliance with conventional bowel preparation agents.

scholarly journals The impact of diet liberalization on bowel preparation for colonoscopy

2017 ◽  
Vol 05 (04) ◽  
pp. E253-E260 ◽  
Author(s):  
James Walter ◽  
Gloria Francis ◽  
Rebecca Matro ◽  
Ramalinga Kedika ◽  
Rachael Grosso ◽  
...  
Keyword(s):  
Adverse Events ◽  
Bowel Preparation ◽  
Final Analysis ◽  
Study Groups ◽  
Detection Rates ◽  
Split Dose ◽  
Colon Cleansing ◽  
Adenoma Detection ◽  
Low Residue Diet ◽  
The Impact

Abstract Background and study aims Dietary restrictions are integral to colonoscopy preparation and impact patient satisfaction. Utilizing split-dose, lower-volume polyethylene glycol 3350-electrolyte solution (PEG-ELS), this study compared colon preparation adequacy of a low-residue diet to clear liquids using a validated grading scale. Patients and methods This was a prospective, randomized, single-blinded, single-center non-inferiority study evaluating diet the day prior to outpatient colonoscopy. Subjects were randomized to a Low-Residue diet for breakfast and lunch, or Clears only. All subjects received split dose PEG-ELS. The primary endpoint was preparation adequacy using the Boston Bowel Preparation Scale (BBPS), with adequate defined as a score > 5. Secondary endpoints included mean BBPS scores for the entire colon and individual segments, satisfaction, adverse events, polyp and adenoma detection rates, and impact on sleep and daily activities. Results Final analysis included 140 subjects, 72 assigned to Clears and 68 to Low-Residue. The Low-Residue diet was non-inferior to Clears (risk difference = – 5.08 %, P = 0.04) after adjusting for age. Mean colon cleansing scores were not significantly different overall and for individual colonic segments. Satisfaction with the Low-Residue diet was significantly greater (P = 0.01). The adenoma detection rate was not statistically significantly different between study groups, but the number of adenomas detected was significantly greater with Clears (P = 0.01). Adverse events and impact on sleep and activities did not differ significantly between diet arms. Conclusions A low-residue diet for breakfast and lunch the day prior to colonoscopy was non-inferior to clear liquids alone for achieving adequate colon cleansing when using split dose PEG-ELS.

scholarly journals The Effectiveness of a Community-Based Mentoring Program for Children Aged 5–11 Years: Results from a Randomized Controlled Trial

2020 ◽  
Vol 22 (1) ◽  
pp. 100-112 ◽  
Author(s):  
Nick Axford ◽  
Gretchen Bjornstad ◽  
Justin Matthews ◽  
Laura Whybra ◽  
Vashti Berry ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Causal Effect ◽  
Controlled Trial ◽  
Well Being ◽  
Mentoring Program ◽  
Post Intervention ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Average Causal Effect ◽  
Superiority Trial

AbstractThe study, a two-arm, randomized controlled, parallel group, superiority trial, aimed to evaluate the implementation and effectiveness of a 12-month one-to-one volunteer mentoring program designed to improve behavioral and emotional outcomes in children aged 5 to 11 years who have teacher- and parent/carer-reported behavioral difficulties. Participants were 246 children (123 intervention, 123 control; mean age 8.4 years; 87% boys) in five sites in London, UK, scoring in the “abnormal” range on the teacher-rated Strengths and Difficulties Questionnaire (SDQ) Total Difficulties measure and in the “borderline” or abnormal range on the parent-rated SDQ Total Difficulties measure. Randomization on a 1:1 ratio took place using a computer-generated sequence and stratifying by site. Data collectors and statisticians were blind to participant allocation status. Outcome measures focused on parent- and teacher-rated child behavior and emotions, and child-rated self-perception and hope. Intention-to-treat analysis on all 246 randomized participants (using imputed data where necessary) showed that at post-intervention (16 months after randomization), there were no statistically significant effects on the primary outcome—parent-rated SDQ Total Difficulties (adjusted standardized mean difference = − 0.12; 95% CI: −0.38 to 0.13; p = 0.33)—or any secondary outcomes. Results from complier average causal effect (CACE) analysis using the primary outcome indicated the intervention was not effective for children who received the recommended duration of mentoring. Exploratory analyses found no sub-group effects on the primary outcome. The article concludes that the mentoring program had no effect on children’s behavior or emotional well-being, and that program content needs revising to satisfactorily address key risk and protective factors.

Impact of preprocedure simethicone on adenoma detection rate during colonoscopy: a multicenter, endoscopist-blinded randomized controlled trial

Endoscopy ◽  
2017 ◽  
Author(s):  
Yu Bai ◽  
Jun Fang ◽  
Sheng-Bing Zhao ◽  
Dong Wang ◽  
Yan-Qing Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Bowel Preparation ◽  
Detection Rate ◽  
Controlled Trial ◽  
Complete Removal ◽  
Adenoma Detection Rate ◽  
Randomized Controlled ◽  
Adenoma Detection ◽  
Bowel Cleansing ◽  
Registration Number

Abstract Background and study aims Ideal bowel preparation for colonoscopy requires complete removal of fluid and foam from the colon. Polyethylene glycol (PEG) is widely used for bowel preparation, with antifoaming agents such as simethicone commonly used in combination with PEG. Data on the effect of simethicone on the adenoma detection rate (ADR) were limited. This study therefore aimed to investigate whether preprocedure simethicone could increase the ADR. Patients and methods This was a prospective, multicenter, endoscopist-blinded randomized controlled trial involving consecutive patients who underwent colonoscopy in six centers in China. Patients were randomly assigned to one of two groups: PEG plus simethicone or PEG alone. The primary outcome was ADR; secondary outcomes were quality of bowel preparation, measured by the Boston bowel preparation scale (BBPS) and bubble scores. Results 583 patients were included. More adenomas were detected in the PEG plus simethicone group than in the PEG alone group (ADR 21.0 % vs. 14.3 %, P = 0.04; advanced ADR 9.0 % vs. 7.0 %, P = 0.38). The mean number of adenomas detected was 2.20 ± 1.36 vs. 1.63 ± 0.89 (P = 0.02). Patients in the PEG plus simethicone group showed better bowel cleansing efficacy: BBPS ≥ 6 in 88.3 % vs. 75.2 % (P < 0.001) and bubble scores of 1.00 ± 1.26 vs. 3.98 ± 2.50 (P < 0.001). Abdominal bloating was reported less frequently in the PEG plus simethicone group (7.8 % vs. 19.7 %, P < 0.001) than in the PEG alone group. Conclusion Combined use of PEG and simethicone is associated with a significantly increased ADR in a Chinese population.Clinical trials registration number: NCT02540239

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

Endoscopy ◽  
2020 ◽  
Vol 52 (11) ◽  
pp. 1026-1035 ◽  
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.

Biomarker prediction of efficacy to vandetanib plus gemcitabine in a phase II double blind multicenter randomized placebo-controlled trial in locally advanced or metastatic pancreatic carcinoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4104-4104 ◽  
Author(s):  
John P. Neoptolemos ◽  
Daniel Palmer ◽  
William Greenhalf ◽  
Paula Ghaneh ◽  
Richard Jackson ◽  
...  
Keyword(s):  
Phase Ii ◽  
Logistic Regression Model ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Prospective Evaluation ◽  
Double Blind ◽  
Once Daily ◽  
Intention To Treat ◽  
Clinical Trial Information

4104 Background: We investigated the potential of biomarkers to predict efficacy of vandetanib and gemcitabine in patients with locally advanced (N = 41) or metastatic (N = 101) pancreatic cancer in a phase II double-blind multicentre randomised placebo-controlled trial. Methods: All patients were 18y or above, (ECOG = 0-2), with at least 3 mths life expectancy had gemcitabine (1000mg/m2 30min iv wkly for 7 wks, followed by a 1wk break, then cycles of wkly treatment for 3wks with a 1-wk break) and randomly assigned to 300mg/d vandetanib or placebo once daily until disease progression. The primary outcome was overall survival (OS) by intention to treat. A panel of potential biomarkers was tested to predict best survival with vandetanib and gemcitabine. Results: 142 patients were randomised, median FU = 24·9 mths with 131 deaths. The median (95% CI) OS in the 70 gemcitabine-placebo patients was 8·95 (6·55-11·7) mths and 8·83 (7·11-11·6) mths in the 72 gemcitabine-vandetanib patients (HR = 1·21, 95% CI = 0·85, 1·73; log rank X21df = 1·1; P = 0·303). A CTCAE V.4.02 rash grade 2 or above occurred in 4 (6 %) of 70 placebo patients versus 14 (19%) of 72 vandetanib patients. The median OS for the 14 vandetanib patients and with rash was 11·92 (10·89 – NA) mths, 7·76 (4·34 – 11·5) mths for the 58 vandetanib patients and without rash and 8·95 (6·55 – 11·7) mths for the gemcitabine-placebo patients (log rank Χ2 2df = 7·23; P = 0·03). We identified two biomarkers that could select patients for response to vandetanib (JN101, JN102). The biomarker combination was present in 26 patients with median OS of 12.1 (10.9, 16.0) mths versus 8.15 (6.67, 11.7) mths for 23 patients with the same biomarker profile in the placebo group (HR = 0.53 [0.29, 0.97], p = 0.0396). A logistic regression model showed that patients with JN102 were more likely to develop a rash (OR =0.81 [0.713, 0.925] p = 0.002). Conclusions: A two biomarker combination and a rash grade 2 or above may predict response to vandetanib and gemcitabine. This requires prospective evaluation. Clinical trial information: 96397434.

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