189 Telephone-Based Re-Education on the Day Before Colonoscopy Improves the Quality of Bowel Preparation and Polyp Detection Rate: a Prospective, Colonoscopist-Blinded, Randomized, Controlled Study

Abstracts

and segment BBPS scores. We also presented 4 standardized colonoscopy videos with varying degrees of bowel cleanliness to participants of the BBPS Educational Program, a web-based program demonstrating the BBPS, and asked for recommended colonoscopy follow-up intervals. Results: Among 3226 average risk colonoscopies with a BBPS score, 1340 (41.5%) had polyps and 601 (18.6%) lacked follow-up recommendations and were thus excluded. The remaining 1285 procedures, performed by 55 endoscopists, had a median (interquartile range) BBPS score of 8 (7-9). Median recommended follow-up time decreased as BBPS scores decreased, with a sharp drop-off below a BBPS score of 6 (see Figure). Among reports with total BBPS score of 6 or 7 (n⫽364), 17 (5%) contained a segment score of 0 or 1 and were associated with shorter median follow-up time compared to reports in which all segment scores were ⱖ2 (5 vs.10 years, P⬍.001). Whenever any colonoscopy contained a single segment score of 1 (n⫽55), that segment’s location (right, left, transverse colon) had no impact on recommended follow-up intervals (P⫽0.955). Video cases were reviewed by 119 endoscopists, including 39 CORI users, 51 non-CORI US endoscopists and 29 international endoscopists. Recommended follow-up time decreased as BBPS scores decreased (P⬍.001; see Table). There was no difference in recommended follow-up time by location of practice, although more US participants (87%) recommended 10 year follow-up compared to international participants (52%) for Case D (P⫽.0012). Conclusions: BBPS scores correlate with endoscopist behavior regarding follow-up intervals for colonoscopy. Because BBPS scores have previously been shown to have excellent inter-rater agreement, a total BBPS score ⱖ 6 and/or all segment scores ⱖ 2 provides a standardized definition of “adequate” when describing bowel cleanliness. Recommended follow-up interval for next colonoscopy for video cases among endoscopists who agreed on the Boston Bowel Preparation Scale score for each case Follow-up recommended, %

Case A N⫽95 Case B N⫽39 Case C N⫽87 Case D N⫽94

BBPS Score, total (R-T-L)

<6 mo

1 yr

3 yr

5 yr

10 yr

Other

2 (0-1-1) 4 (0-2-2) 6 (1-2-3) 8 (2-3-3)

60.0 30.8 8.1 0

23.0 28.2 18.5 1.1

5.3 12.8 13.8 2.1

9.5 15.4 27.6 16.0

2.1 12.8 26.4 78.7

0 0 4.6 2.1

189 Telephone-Based Re-Education on the Day Before Colonoscopy Improves the Quality of Bowel Preparation and Polyp Detection Rate: a Prospective, Colonoscopist-Blinded, Randomized, Controlled Study Xiaodong Liu1, Hui Luo1, Lin Zhang1, Felix W. Leung2, Daiming Fan1, Yanglin PAN*1, Xuegang Guo1 1 Department of Gastroenterology, Xijing Hospital, Fourth Military Medical University, Xi’an, China; 2David Geffen School of Medicine at UCLA, Los Angeles, CA Background: Despite advances in bowel preparation methods, the quality of bowel preparation in patients undergoing colonoscopy remains unsatisfactory. The time point chosen for improvement of education may be important for adequate bowel preparation. Objective: To evaluate the effect of telephone re-education on the day before colonoscopy (instead of the day of appointment - regular appointment) on the quality of bowel preparation and colonoscopic findings. Design: Prospective, colonoscopist-blinded, randomized, controlled study (NCT01584817). Setting: Tertiary care center in China. Patients: Outpatients made an appointment for colonoscopy. Intervention: Subjects were randomly assigned to receive telephone-based re-education on the day before colonoscopy (re-education group) or routine education on the day of appointment (control group) for bowel preparation. Primary outcome: the rate of adequate bowel preparation (defined by Ottawa score⬍6). Secondary outcomes: polyp detection rate, non-compliance rate to instruction, willingness to repeat bowel preparation, et al. Statistical analysis: SPSS 19.0 was used. A 2-tailed p⬍0.05 was considered significant. Results: A total of 605 patients were randomized with 305 in re-education group and 300 in control group (Figure 1). The baseline characteristics between the two groups were well balanced. In an intention-to-treat analyses of the primary outcome (the rate of adequate bowel preparation) and colonoscopic findings (Table 1), an adequate preparation was found in 81.6% vs. 70.3 % of reeducation and control patients, respectively (p⬍0.001). Polyp detection rate was 38.0% vs. 24.7% in re-education and control group respectively (p⬍0.001). Among patients with successful colonoscopy, the Ottawa scores were 3.0⫾2.3 in re-education group and 4.9⫾3.2 in control group (p⬍0.001). Fewer patients with non-compliance to instruction were found in reeducation group (9.4% vs. 32.8%, p⬍0.001). No significant differences were observed between the two groups regarding the willingness to have a repeat bowel preparation (p⫽0.613). Both univariate and multivariate analysis revealed that constipation, regular instruction without telephone re-education, improper beginning time of bowel preparation and improper diet restriction were factors significantly associated with inadequate bowel preparation (defined by Ottawa score⬎⫽6) for colonoscopy (all p⬍0.05). Limitations: Single center. Conclusion: This prospective RCT, to our knowledge, is the first to show that telephone re-education about the details of bowel preparation on the day before colonoscopy improved the quality of bowel preparation and polyp detection rate. Table 1. Effect of telephone re-education on the outcome of bowel preparation and colonoscopy

Median recommended follow-up interval for next colonoscopy by Boston Bowel Preparation Scale score among 1285 colonoscopies performed

Adequate bowel preparation polyethylene glycol sodium phosphate Incomplete colonoscopy Inadequate preparation Technical difficult or stricture Successful colonoscopy Ottawa score Left Transverse Right Fluid volume Cecal intubation time Withdrawal time Colonoscopic findings Polyp Diverticulum Ulcerative colitis Cancer Other non-compliance to instructions Improper beginning time Improper diet restriction

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Re-education

Control

p value

249/305 (81.64%) 194/237 (81.86%) 55/68 (80.88%) 14/276 (5.07%) 5/276 (1.81%) 9/276 (3.26%) 262/276 (94.9%) 3.0⫾2.3 1.3⫾1.0 0.5⫾0.8 1.0⫾0.9 0.2⫾0.5 7.7⫾5.5 6.2⫾2.3

211/300 (70.33%) 161/230 (70%) 50/70 (71.43%) 40/271 (14.76%) 29/271 (10.7%) 11/271 (4.06%) 231/271 (85.2%) 4.9⫾3.2 1.8⫾1.1 0.9⫾1.1 1.5⫾1.0 0.6⫾0.7 7.6⫾4.3 7.8⫾2.8

0.001 0.003 0.193 ⬍0.001 ⬍0.001 0.619 ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001 0.576 ⬍0.001

116/305 (38.03%) 21/305 (6.89%) 15/305(4.92%) 6/305 (1.97%) 4/305(1.31%) 26/276 (9.42%)

74/300 (24.67%) 10/300 (3.33%) 13/300 (4.33%) 3/300 (1.0%) 4/300(1.33%) 89/271 (32.84%)

⬍0.001 0.048 0.732 0.326 0.981 ⬍0.001

12 11

34 58

⬍0.001 ⬍0.001

www.giejournal.org

Abstracts

Failure to follow purgative instruction

Re-education

Control

p value

10

11

0.709

Figure 1. Flowchart of the study.

190 Outcomes of Smart Phone Application Assisted Bowel Preparation for Colonoscopy Nilay H. Kavathia*1, Paul Berggreen2, Richard Gerkin2 1 Gastroenterology, Carl T Hayden VA, Phoenix, AZ; 2Gastroenterology, Banner Good Samaritan, Phoenix, AZ Background: The success of a colonoscopy is largely based on the quality of bowel preparation achieved by the patient. Patients are given medications and instructions on taking the medications, and when to change their diet prior to the colonoscopy. The quality of the endoscopic exam is directly related to the quality of the bowel preparation completed by the patient. A sub-optimal bowel preparation can lead to compromised exams with missed polyps, an increase in procedure time, more frequent surveillance, and aborted exams. To increase the quality of bowel preps, a smart phone application was created. A patient would download this free app on to their smart phone. The patient would input the time, date, and medication chosen by the physician, and timed alerts would appear on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app would assist in bowel preparation by explaining the procedure, providing tips, and displaying pictures of preparation quality. This was the same information previously provided on paper. The purpose of the app is to lead to better bowel preps and to increase patient satisfaction. Aim: To study the quality of bowel preparations in patients who use the assistance of a smart phone application. Methods: The study was done in two phases. The first phase was prior to the release of the application. All patients were asked if they owned a smart phone and the likelihood of using the app. The endoscopist was blinded to their answers and the quality of preparation was scored using the Boston Bowel Preparation Scale (BBPS). In phase two, patients were alerted and given instructions on how to download the application. At time of the colonoscopy, they were asked if they used the application and their satisfaction with the app. Again, the endoscopist was blinded to the answers and scored the bowel prep using BBPS. Statistical analysis was done using the Wilcoxon signedrank test. Results: There were 326 patients in phase 1 of the study. Of them, 49% of the patients owned a smart phone (n⫽162). These patients were compared to the patients without smart phones (n⫽ 164). There was no significant difference in the BBPS scores for patients with smart phones versus those without. The average BBPS for those with smart phones was 6.92 (SD 1.72) vs 6.76 (SD 1.79) for those without, p ⫽ 0.414. The early data shows app users (n⫽16) had average BBPS scores of 8.19 (SD 1.05). There is a statically significant improvement when compared to smart phone owners from phase one of the study, p ⫽0.003. Conclusions: Early data is promising showing a statistically significant improvement in bowel preparation quality in patients who used the smart phone application. The phase two data is being collected over the next months to see if this trend continues with a larger population. Preliminary Data on Smart Phone App Assisted Bowel Prep

Smart Phone Owners, Phase 1 App Users, Phase 2

www.giejournal.org

N

BBPS

p

162 16

6.92 (SD1.72) 8.19 (SD 1.05)

p⫽ 0.003

191 Metabolic Effects of Sodium Picosulfate/Magnesium Citrate (Citrafleet®) Bowel Preparation in Healthy Adults: Evaluation of Four Dosing Regimens David H. Balaban*1, Nabil AL-Tawil2, William O. Thompson3, Carlos J. Badiola4, Deborah J. GALT5 1 Charlottesville Gastroenterology Associates, Charlottesville Medical Research, Charlottesville, VA; 2Karolinska Trial Alliance Phase-I Unit, Karolinska University Hospital, Stockholm, Sweden; 3Department of Biostatistics and Epidemiology, Georgia Health Sciences University, Augusta, GA; 4Casen-Fleet Laboratories, Madrid, Spain; 5Fleet Laboratories, Lynchburg, VA Sodium picosulfate/magnesium citrate (SPMC) is widely used as a bowel preparation prior to colonoscopy and has recently been approved in the U.S. Electrolyte changes are common with osmotic bowel preparation. Aim: To evaluate the time course of electrolyte changes, hemodynamic effects, and tolerability of four dosing regimens of SPMC. Methods: Healthy subjects balanced for age (40-64 yr and ⱖ65 yr) and gender were admitted to a Phase I clinical study unit. Subjects were administered two doses of 15.08 g SPMC according to one of four dosing regimens emulating precolonoscopy dosing schedules: PM/AM (1900/0700), AM/PM (0800/1500), PM/PM (1500/2000), or AM/AM (0600/1000). Screening serum chemistries were measured between 28 and 2 days prior to study entry, before drug administration (baseline), and hourly after the first dose up to 16 hours after the second dose. Vital signs were recorded pre- and post-dosing. Subjects completed a tolerability questionnaire, and investigators recorded any adverse events (AE). Results: 79 subjects were enrolled. The majority of subjects (85.7%) demonstrated elevated serum magnesium levels after SPMC administration, but no differences between dosing regimens were observed. The mean change in magnesium from baseline ranged from ⫹0.31 to ⫹0.37 mEq/L among the dosing groups, and none of the changes were deemed clinically significant. Four subjects had sodium levels below reference range at baseline; treatment-emergent hyponatremia was observed in 25/75 (33.3%) remaining subjects. The incidence of hyponatremia and the mean percentage of abnormal serum sodium levels recorded were highest among AM/AM subjects (see Table 1). The lowest recorded serum sodium level was 129 mEq/L in an asymptomatic AM/AM female subject and may have been related to excessive fluid ingestion (⬎8 L). No changes in serum sodium were considered clinically significant. There were no clinically significant changes in serum creatinine, potassium or calcium from baseline with regard to dosing regimen, age group, or gender. Syncope was observed in a 62-year-old female subject in the PM/PM regimen attributed to a vasovagal event; no significant electrolyte changes were observed in this subject. Among the remaining subjects, no clinically significant changes in pulse or blood pressure were observed. The majority of subjects (72/79) considered SPMC easy or very easy to take. Conclusions: Mild hypermagnesemia and hyponatremia are commonly observed following SPMC administration. There is a trend toward an increasing incidence of hyponatremia as the dosing interval decreases, which might be accentuated when both doses are administered in the morning. Subjects at risk for hyponatremia during bowel preparation with SPMC should be properly monitored and should receive divided doses of SPMC at longer intervals. Table 1. Incidence of hyponatremia Minimum Mean percentage sodium Subjects with Interval level hyponatremia and abnormal Subjects with between doses Total treatment-emergent > 3 mEq/L drop in sodium recorded Dosing (mEq/L) levels Na from baseline hyponatremia (hrs) subjects schedule PM/AM AM/PM PM/PM AM/AM TOTAL

12 7 5 4

16 20 19 20 75

4 (25%) 5 (25%) 6 (31.6%) 10 (50%) 25 (33.3%)

2 2 5 5 14

6.3% 10.2% 17.3% 34.2%

135 136 134 129

192 A Prospective, Comparative Audit of Two Commonly Used, Low Volume Bowel Preparations for Routine Colonoscopy: MoviPrep Versus a Senna and Citramag Combination Kinesh P. Patel*, Rishi K. Fofaria, Siwan Thomas-Gibson, Brian P. Saunders Wolfson Unit for Endoscopy, St Mark’s Hospital, Harrow, United Kingdom Background: Colonoscopy is the principle therapeutic tool for colorectal cancer prevention. Adenoma removal has been shown to decrease the incidence of colorectal cancer in screened populations. Good visualisation of the entire colonic mucosa is essential for high rates of adenoma detection. The optimal preparation regimen for bowel preparation has not yet been defined. Aim/Methods: The aim was to assess the effectiveness of different regimens for bowel preparation, comparing low volume polyethylene glycol (Moviprep, Norgine, UK) with senna and magnesium citrate (Citramag, Sanochemia Diagnostics UK). Split dosing was

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