Optimal Timing of Simethicone Supplement for Bowel Preparation: A Prospective Randomized Controlled Trial
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ABSTRACT: Background and Aims
Simethicone (SIM), as an antifoaming agent, has been shown to improve bowel preparation during colonoscopy. However, the optimal timing of SIM addition remained undetermined. We aimed to investigate the optimal timing of SIM addition to polyethylene glycol (PEG) to improve bowel preparation. Methods
Eligible patients were randomly assigned to two groups: the SIM evening group (SIM addition to PEG in the evening of the day prior to colonoscopy) and the SIM morning group (SIM addition to PEG in the morning of colonoscopy). The primary outcome was Bubble Scale (BS). The secondary outcomes were Boston Bowel Preparation Scale (BBPS) and adenoma detection rate (ADR). Results
A total of 419 patients were enrolled in this study. The baseline characteristics of the patients were similar in both groups. No significant differences were observed in terms of BS (8.76 ± 0.90 vs. 8.65 ± 1.16, P = 0.81), ADR (34.1% vs. 30.8%, P = 0.47), Boston Bowel Preparation Scale (BBPS) (8.59 ± 0.94 vs. 8.45 ± 1.00, P = 0.15), and withdrawal time (8.22 ± 2.04 vs. 8.01 ± 2.51, P = 0.094) between the two groups. Moreover, safety and compliance were similar in both groups. However, the SIM evening group was associated with shorter cecal intubation time (3.80 ± 1.81 vs. 4.42 ± 2.03, P < 0.001), higher BS (2.95 ± 0.26 vs. 2.88 ± 0.38, P = 0.04) in the right colon, and diminutive ADR (62.5% vs. 38.6%, P = 0.022) in the right colon, when compared to the SIM evening group. Conclusions
The SIM addition to PEG in the evening of the day prior to colonoscopy can shorten cecal intubation time and improve BS scores and diminutive ADR of the right colon compared with the SIM addition to PEG in the morning of colonoscopy in bowel preparation.
SUBMITTER: Wu Z
PROVIDER: S-EPMC8566047 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe presence of small air bubbles and foam are an impediment to a successful colonoscopy. They impair an endoscopist's view and diminish the diagnostic accuracy of the study. This has been particularly noted to be of concern with the switch to lower volume polyethylene glycol (PEG) and bisacodyl combination preparation.AimTo evaluate the effect of oral simethicone addition to bowel preparation on intraluminal bubbles reduction during colonoscopy.MethodsDescribed is a prospective, randomized, multi-center, double-blinded, placebo-controlled study to evaluate the use of premixed simethicone formulation with split-regimen, low-volume PEG-bisacodyl combination bowel preparation for 168 outpatients undergoing screening, surveillance, and diagnostic colonoscopies. Primary outcome includes evaluation of bubbles during colonoscopy graded using the Intraluminal Bubbles Scale. Secondary outcomes include evaluation of the Boston Bowel Preparation Scale (BBPS), total number of polyps, polyp size differentiation, polyp laterality, adenoma detection, mass detection, cecal insertion time, withdrawal time, and patient-reported adverse events.ResultsHigher Intraluminal Bubbles grades III and IV (less than 75% of the mucosa cleared of bubbles/foam requiring intervention with simethicone infused wash) were detected in the placebo group [Simethicone n = 4/84 vs Placebo n = 20/84 (P = 0.007)]. BBPS total score was 7.42 [standard deviation (SD) = ± 1.51] in the simethicone group and 7.28 (SD = ± 1.44) in the placebo group (P = 0.542) from a total of 9. Significantly higher number of adenomas were detected in the simethicone group (P = 0.001).ConclusionThe addition of simethicone to bowel preparation is well advised for its anti-foaming properties. The results of this study suggest that addition of oral simethicone can improve bowel wall visibility.
| S-EPMC6580307 | biostudies-literature
Project description:Background and aimLow-volume polyethylene glycol with ascorbic acid (PEG-Asc) use is reported to be as safe and effective as traditional 4-L polyethylene glycol use. However, PEG-Asc produces bubbles, which cause problems during colonoscopy. Data on the effects of using antifoaming agents such as simethicone with PEG-Asc are lacking. The aim of this CONSORT-prospective, randomized, observer-blinded, controlled trial is to compare the quality of bowel preparation and compliance between PEG-Asc users and PEG-Asc plus simethicone users.MethodsAdult outpatients aged 18 to 80 years undergoing colonoscopy were recruited to the study. Two hundred sixty patients were randomly assigned to 1 of 2 treatment arms, PEG-Asc or PEG-Asc plus simethicone. The primary outcome measure was the bowel cleansing quality using Boston bowel preparation scale and bubble scores. The secondary outcome measures were patient tolerability and doctor tolerability.ResultsThe simethicone group showed superior cleansing results (6-9 Boston scale scores: 99% vs. 84%, <5% bubble scores: 96% vs. 49%, P < 0.001) and fewer gastrointestinal symptoms (abdominal fullness: 24% vs. 55%, colicky pain: 5% vs. 24%, P < 0.001) than the non-simethicone group. Moreover, endoscopist fatigue during colonoscopy was lower in the simethicone group than in the non-simethicone group (1.31 ± 0.75 vs. 2.97 ± 2.14, P < 0.001).ConclusionPEG-Asc plus simethicone use was more effective and associated with better patient and endoscopist tolerance than PEG-Asc use. Therefore, this combination is recommended as one of the promising methods for bowel preparation before colonoscopy.
| S-EPMC4956803 | biostudies-literature
Project description:ObjectiveTo compare surgeons' intraoperative surgeon acceptability or assessment of the operative field regarding bowel contents and patients' satisfaction with or without a mechanical bowel preparation before reconstructive vaginal prolapse surgery.MethodsIn this single-blind, randomized trial, women scheduled to undergo vaginal prolapse surgery with a planned apical suspension and posterior colporrhaphy were allocated using block randomization to an intervention or control group. Surgeons were blinded to patient allocation. One day before surgery, mechanical bowel preparation instructions consisted of a clear liquid diet and two self-administered saline enemas; the participants in the control group sustained a regular diet and nothing by mouth after midnight. The primary outcome was surgeons' intraoperative assessment of the surgical field regarding bowel content as measured on a 4-point Likert scale (1, excellent; 4, poor). Secondary outcomes included participant satisfaction and bowel symptoms. The primary outcome was determined by intention-to-treat analysis and other analyses were per protocol.ResultsOf the 150 women randomized (75 women to intervention and control group), 145 completed the study. No differences existed in the demographic, clinical, and intraoperative characteristics between groups (P>.05). Surgeons' intraoperative assessment rating was 85% "excellent or good" with bowel preparation compared with 90% for participants in the control group (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.21-1.61; P=.30). The bowel preparation group was less likely to report "complete" satisfaction compared with the participants in the control group (OR 0.11, 95% CI 0.04-0.35; P<.001). Abdominal fullness and cramping, fatigue, anal irritation, and hunger pains were greater in the bowel preparation group (all P<.01).ConclusionBefore reconstructive vaginal surgery, mechanical bowel preparation conferred no benefit regarding surgeons' intraoperative assessment of the operative field, reflected decreased patient satisfaction, and had increased abdominal symptoms.Clinical trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT01431040.Level of evidenceI.
| S-EPMC3909883 | biostudies-literature
Project description:BackgroundCapsule endoscopy (CE) is frequently hindered by intra-luminal debris. Our aim was to determine whether a combination bowel preparation would improve small-bowel visualization, diagnostic yield, and the completion rate of CE.MethodsSingle-blind, prospective randomized-controlled study of outpatients scheduled for CE. Bowel-preparation subjects ingested 2 L of polyethylene glycol solution the night prior to CE, 5 mL simethicone and 5 mg metoclopramide 20 minutes prior to CE and laid in the right lateral position 30 minutes after swallowing CE. Controls had no solid food after 7 p.m. the night prior to CE and no liquids 4 hours prior to CE. Participants completed a satisfaction survey. Capsule readers completed a small-bowel-visualization assessment.ResultsFifty patients were prospectively enrolled (56% female) with a median age of 54.4 years and 44 completed the study (23 patients in the control group and 21 in the preparation group). There was no significant difference between groups on quartile-based small-bowel visualization (all P > 0.05). There was no significant difference between groups in diagnostic yield (P = 0.69), mean gastric (P = 0.10) or small-bowel transit time (P = 0.89). The small-bowel completion rate was significantly higher in the preparation group (100% vs 78%; P = 0.02). Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%; P = 0.01).ConclusionsCombined bowel preparation did not improve small-bowel visualization but did significantly increase patient discomfort. The CE completion rate improved in the preparation group but the diagnostic yield was unaffected. Based on our findings, a bowel preparation prior to CE does not appear to improve CE performance and results in decreased patient satisfaction (ClinicalTrials.gov, No. NCT01243736).
| S-EPMC7217271 | biostudies-literature
Project description:Introduction and hypothesisThe objective was to determine if a bowel preparation prior to minimally invasive sacrocolpopexy (MIS) influences post-operative constipation symptoms. We hypothesized that women who underwent a bowel preparation would have an improvement in post-operative defecatory function.MethodsIn this randomized controlled trial, women undergoing MIS received a pre-operative bowel preparation or no bowel preparation. Our primary outcome was post-operative constipation measured by the Patient Assessment of Constipation Symptoms (PAC-SYM) 2 weeks post-operatively. Secondary outcomes included surgeon's perception of case difficulty. Both intention-to-treat (ITT) and per-protocol analyses (PPA) were performed. Analyses were carried out using t test, Fisher's exact test, the Wilcoxon test and the Chi-squared test.ResultsOf 105 enrolled women, 95 completed follow-up (43 preparation and 52 no preparation). Baseline characteristics and rates of complications were similar. No differences were noted on ITT. The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08, p = 0.045). Women who underwent a preparation were less likely to report strain (6.0% vs 26.7%, p = 0.009) or type 1 Bristol stool on their first post-operative bowel movement (4.3% vs 17.5%, p = 0.047). Surgeons were more likely to rate the complexity of the case as "more difficult than average" (54.4% vs 40.1%, p = 0.027) in those without a bowel preparation.ConclusionsAlthough there was no difference in ITT analysis, women who underwent a bowel preparation prior to MIS demonstrated benefit to post-operative defecatory function with a corresponding improvement in surgeon's perception of case complexity.
| S-EPMC7247935 | biostudies-literature
Project description:AimTo evaluate the effectiveness of simethicone in enhancing visibility and efficacy during colonoscopy.MethodsA prospective, double-blind, randomized, placebo-controlled study was conducted. One hundred and twenty-four patients were allocated to receive 2 doses of sodium phosphate plus 240 mg of tablet simethicone or placebo as bowel preparation. Visibility was blindly assessed for the amount of air bubbles and adequacy of colon preparation. Total colonoscopic time, side effects of the medication, endoscopist and patient satisfaction were also compared.ResultsSodium phosphate plus simethicone, compared to sodium phosphate plus placebo, improved visibility by diminishing air bubbles (100.00% vs 42.37%, P < 0.0001) but simethicone failed to demonstrate improvement in adequacy of colon preparation (90.16% vs 81.36%, P = 0.17). Endoscopist and patient satisfaction were increased significantly in the simethicone group. However, there was no difference in the total duration of colonoscopy and side effects of the medication.ConclusionThe addition of simethicone is of benefit for colonoscopic bowel preparation by diminishing air bubbles, which results in enhanced visibility. Endoscopist and patient satisfaction is also increased.
| S-EPMC2702112 | biostudies-literature
Project description:BackgroundAdequate bowel preparation is essential for the visualization of the colonic mucosa during colonoscopy. However, the rate of inadequate bowel preparation is still high, ranging from 18% to 35%; this may lead to a higher risk of missing clinically relevant lesions, procedural difficulties, prolonged procedural time, an increased number of interval colorectal carcinomas, and additional health care costs.ObjectiveThe aims of this study are to compare bowel preparation instructions provided via a personalized smartphone app (Prepit, Ferring B V) with regular written instructions for bowel preparation to improve bowel preparation quality and to evaluate patient satisfaction with the bowel preparation procedure.MethodsEligible patients scheduled for an outpatient colonoscopy were randomized to a smartphone app group or a control group. Both the groups received identical face-to-face education from a research physician, including instructions about the colonoscopy procedure, diet restrictions, and laxative intake. In addition, the control group received written information, whereas the smartphone app group was instructed to use the smartphone app instead of the written information for the actual steps of the bowel preparation schedule. All patients used bisacodyl and sodium picosulfate with magnesium citrate as laxatives. The quality of bowel preparation was scored using the Boston Bowel Preparation Scale (BBPS) by blinded endoscopists. Patient satisfaction was measured using the Patient Satisfaction Questionnaire-18.ResultsA total of 87 patients were included in the smartphone app group and 86 in the control group. The mean total BBPS score was significantly higher in the smartphone app group (mean 8.3, SD 0.9) than in the control group (mean 7.9, SD 1.2; P=.03). The right colon showed a significantly higher bowel preparation score in the smartphone app group (mean 2.7, SD 0.5 vs mean 2.5, SD 0.6; P=.04). No significant differences were observed in segment scores for the mean transverse colon (mean 2.8, SD 0.4 vs mean 2.8, SD 0.4; P=.34) and left colon (mean 2.8, SD 0.4 vs mean 2.6, SD 0.5; P=.07). General patient satisfaction was high for the smartphone app group (mean 4.4, SD 0.7) but showed no significant difference when compared with the control group (mean 4.3, SD 0.8; P=.32).ConclusionsOur personalized smartphone app significantly improved bowel preparation quality compared with regular written instructions for bowel preparation. In particular, in the right colon, the BBPS score improved, which is of clinical relevance because the right colon is considered more difficult to clean and the polyp detection rate in the right colon improves with improvement of bowel cleansing of the right colon. No further improvement in patient satisfaction was observed compared with patients receiving regular written instructions.Trial registrationClinicalTrials.gov NCT03677050; https://clinicaltrials.gov/ct2/show/NCT03677050.
| S-EPMC8414298 | biostudies-literature
Project description:To compare mechanical bowel preparation (MBP) using oral magnesium citrate with sodium phosphate enema to sodium phosphate (NaP) enema alone during minimally invasive pelvic reconstructive surgery.We conducted a single-blind, randomized controlled trial of MBP versus NaP in women undergoing minimally invasive pelvic reconstructive surgery. The primary outcome was intraoperative quality of the surgical field. Secondary outcomes included surgeon assessment of bowel handling and patient-reported tolerability symptoms.One hundred fifty-three participants were enrolled; 148 completed the study (71 MBP and 77 NaP). Patient demographics, clinical and intraoperative characteristics were similar. Completion of assigned bowel preparation was similar between MBP (97.2%) and NaP (97.4%). The MBP group found the preparation more difficult (P<0.01) and reported more overall discomfort and negative preoperative side effects (all P?0.01). Quality of surgical field at initial port placement was excellent/good in 80.0% of the MBP group compared with 62.3% in the NaP group (P=0.02). This difference was not maintained by the conclusion of surgery (P=0.18). Similar results were seen in the intent-to-treat population. Surgeons accurately guessed preparation 65.7% of the time for MBP versus 41.6% for NaP (P=0.36). At 2 weeks postoperatively, both reported a median time for return of bowel function of 3.0 (2.0-4.0) days.Mechanical bowel preparation with oral magnesium citrate before minimally invasive pelvic reconstructive surgery offered initial improvement in the quality of surgical field, but this benefit was not sustained. It was associated with an increase in patient discomfort preoperatively, but did not seem to impact postoperative return of bowel function.I.
| S-EPMC5161559 | biostudies-literature
Project description:Enema administration in the morning of routine colonoscopy is known to be useless. However, the potential bowel cleansing effects of distal colon emptying with enema prior to purgatives are not known. The aim of this study is to investigate the effects of enema use before purgatives in preparation for colonoscopy.Two hundred twenty-seven patients were randomly assigned into three groups; enema before purgative use, enema after purgative use, and no enema. Patients were compared in terms of age, sex, BMI, Rome III constipation criteria, history of abdominal surgery, tolerance to the preparation procedure, complications during preparation such as nausea, vomiting, headache and dizziness, cecal insertion time, total duration of colonoscopy, polyp determination rate and colonic cleansing based on the Boston Bowel Preparation Scale.One hundred two (44.9%) patients were male and 125 (55.1%) female. The mean age and BMI was 55.4±11.8 years and 28.8±4.7, respectively. No difference was observed between the groups in terms of sex, age, or BMI. The number of fulfilled Rome criteria and of previous abdominal surgeries were significantly higher in females than in men. Right colon Boston Bowel Preparation Scale score was higher in the group using enemas before purgatives than the scores of other groups. This improvement was statistically significant in the female patient group with higher constipation rate.Use of enemas before purgatives in patients with constipation significantly improves adequacy of right colon cleansing.
| S-EPMC5448567 | biostudies-other
Project description:BackgroundSurgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis.Methods/designIn this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5% surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years.DiscussionThe results of this randomized controlled trial will have an important impact on current international guidelines for infection control strategies in the hospital. Moreover, the results of this randomized controlled trial are of significant interest for patient safety and healthcare economics.Trial registrationThis trial is registered on ClinicalTrials.gov under the identifier NCT01790529.
| S-EPMC4040488 | biostudies-literature