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Su1537 Impact of Bowel Preparation Type on the Quality of Colonoscopy
Abstracts
Su1537 Impact of Bowel Preparation Type on the Quality of Colonoscopy Jinma Ren*1, Daniel Martin2, Karthik Ragunathan2, Carl Asche1, Michael D. Cashman2, Srinivas R. Puli2, Sonu Dhillon2 1 Medicine, University of Illinois College of Medicine at Peoria, Peoria, IL; 2 OSF Medical Center, Peoria, IL Background and Objective: High-quality bowel preparation is crucial for achieving the goals of colonoscopy. However, choosing a bowel preparation in clinical practice can be a challenge because of the many formulations. This study aims to assess the impact of bowel preparation type on the quality of colonoscopy in a community setting. Methods: A retrospective, observational study was conducted utilizing a colonoscopy screening/surveillance database in central Illinois during the period of January 1, 2010 to March 31, 2014. Patients without bowel preparation assessment were excluded from this study. An ordinal logistic regression model was used to estimate the adjusted impact [odds ratio (OR)] of bowel preparation type on the quality of preparation (excellent, good, fair and poor) based on the Boston Bowel Preparation scale. The association between the time of withdrawal after insertion and the quality of preparation was also examined using a linear model. Results: The half of patients (28,386) was male. The majority (70%) of bowel preparations used polyethylene glycol (PEG), followed by sodium sulfate (21%), sodium phosphate (2%), magnesium sulfate (0.3%) and others. Compared to PEG, magnesium sulfate had a poorer quality of bowel preparations (ORZ0.7, 95% CI 0.4-1.0; p!0.05), whereas the quality of bowel preparation was significantly improved by using sodium sulfate (ORZ6.1, 95% CI 5.4-6.5; p!0.05), sodium phosphate (ORZ2.1, 95% CI 1.8-2.5; p!0.05) and other types (ORZ1.2, 95%CI 1.0-1.6; p!0.05). The rate of examination completion was higher in patients with adequate preparations as compared to those with inadequate preparations (99.4% vs 88.4%, p!0.05). Among patients with a high quality preparation, withdrawal times decreased (median time 911 minutes). Conclusion: When possible, sodium sulfate based preparations should be recommended in the community setting for colonoscopy because of their high quality preparation.
Su1538 The Safety and Feasibility Study of Bowel Cleaning Agents MoviPrepâ Versus Niflecâ for the Patients With Inflammatory Bowel Diseases Undergoing Colonoscopy and Balloon Enteroscopy: a Single Center Randomized Controlled Trial Shingo Kato*, Kazuhito Kani, Taisuke Kobayashi, Ryuichi Yamamoto, Sumiko Nagoshi, Koji Yakabi Saitama Medical Center, Saitama Medical University, Kawagoe City, Japan Background and Aims: MoviprepÒ (MOV) is a bowel cleaning agent with high osmotic pressure. However, it’s not cleared whether MOV could be used safely in patients with active inflammatory bowel diseases (IBDs) because there is a possibility that dehydration aggravates clinical condition of these patients. The aim of this study was to evaluate the safety and cleansing effects of MOV compared to NiflecÒ (NIF) in patients with IBD. Methods: This study was approved by the Institutional Review Board of Saitama Medical Center, and also registered in UMIN (UMIN000010609). Scheduled number of IBD-patients who will be enrolled is 80 patients consisted of 20 active and 20 quiescent UC-patients, and 20 active and 20 quiescent CD-patients. Here we report the results of the interim analysis of this study which consists of 36 UC- and 34 CD- patients. In a single-blinded randomized trial, MOV was compared with NIF in IBD-patients undergoing colonoscopy or balloon enteroscopy from anus. Patients filled out questionnaires grading from 0 (bad) to 5 (good) concerning taste, volume and selection of MOV or NIF in next time examination and discomfort of MOV or NIF. Blinded colonoscopists estimated the efficiency of the cleansing using the cleansing scale grading from 1 (good) to 5 (bad). Primary endpoint was cleansing efficacy of MOV and NIF. Secondary endpoints were blood and urinary osmotic pressure after taking bowel cleansing agents, patient’s acceptability and event-ratio of side effects. Results: About primary endpoint, cleansing efficacy of transverse, descending and sigmoid colon was significantly higher in MOV than NIF group (MOV vs NIF, 1.54 0.70 vs 1.52 0.73 in cecum and ascending colon, pZ0.12;1.14 0.55 vs 1.38 0.62 in transverse colon, pZ0.00054; 1.140.55 vs 1.310.61 in descending colon, pZ0.0026; 1.1710.57 vs 1.1720.47, in sigmoid colon, pZ0.0042; 1.170.57 vs 1.14 0.44 in rectum, pZ0.07). About acceptability, taste- and volume-acceptability were significantly higher in MOV than NIF group (MOV vs NIF, taste, 3.371.03 vs 2.47 0.99, pZ0.0013; volume, 2.891.08 vs 2.260.99, pZ0.046). However, no significance was recognized in the selection of bowel cleaning agent in next time examination (MOV vs NIF, 3.81.05 vs 3.350.85, pZ0.052). Concentration of urine osmotic pressure was significantly higher in MOV group than in NIF group (MOV vs NIF, 630222 vs 509262 Osm, pZ0.045). However, there was no significance between MOV group and NIF group in bloody osmotic pressure (MOV vs NIF, 2834.39 vs 2825.02 Osm, pZ0.88). And also there was no significance between MOV group and NIF group in event-ratio of side effects (MOV vs NIF, 18.9 vs 8.8%, pZ0.88). Conclusion: MOV has good cleansing effects than NIF in IBD patients. And also MOV could be safely used in IBD-patients as well as NIF because of no disturbance in blood osmotic pressure.
AB320 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
Su1539 Safety, Efficacy, and Tolerability of a Low-Volume Sodium Picosulfate/Magnesium Citrate Bowel Preparation in Patients Aged 50 Years and Younger Gerald Bertiger*1, Richard Willey2, Raymond E. Joseph2, Morris Barocas2 1 Hillmont G.I., Flourtown, PA; 2Ferring Pharmaceuticals Inc., Parsippany, NJ Background: Guidelines recommend that individuals begin regular screening for colorectal cancer at age 50; nonetheless, colonoscopies are routinely performed in patients younger than 50 years old. A positive bowel preparation experience may help increase patient adherence to screening guidelines later in life. To address bowel preparation needs in these patients, we performed a post hoc analysis to characterize the efficacy, safety, and tolerability of a low-volume bowel preparation prior to colonoscopy in adults aged %50 years. Methods: Data were obtained from 2 phase 3, randomized, multicenter, assessor-blinded studies that investigated splitdose (Rex DK, et al. Gastrointest Endosc. 2013;78:132) or day-before (Katz P, et al. Am J Gastroenterol. 2013;108:401) dosing of a nonphosphate, dual-action, low-volume preparation containing sodium picosulfate, magnesium oxide, and anhydrous citric acid (P/MC) compared with per labeled dosing of 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (2L PEG+bis) in adults preparing for colonoscopy. In this post hoc analysis, efficacy, safety, and tolerability data were separately analyzed for patients aged %50 years. Overall colon cleansing was rated using a modified Aronchick scale in which cleansing was considered successful if the rating was “excellent” or “good”. Patient tolerability was ascertained on the day of colonoscopy from a 7-item questionnaire administered prior to any preliminary sedation. Safety was assessed by the incidence of adverse events (AEs). Results: A total of 172 patients aged %50 years were included in the intent-to-treat population (ITT) from the study of split-dose P/MC and 133 patients aged %50 years were included from the study of day-before P/MC. Successful bowel cleansing was obtained in 84% of P/MC patients and 89% of P/MC patients in the split-dose and daybefore study, respectively. There was no significant difference in overall colon cleansing between P/MC and 2L PEG+bis in either study in patients aged %50 years. A significantly greater proportion of patients in the P/MC treatment group rated their bowel preparation as “easy”/“very easy” to consume compared with patients in the 2L PEG+bis group (split-dose study, 89% vs 21%; day-before study, 86% vs 27%; P! 0.0001). Overall patient experience was higher in the P/MC group compared with 2L PEG+bis, and a greater proportion of patients indicated they would request P/MC for a future colonoscopy (P!0.01). Combined safety data from both studies show the most common AEs (O2% of patients) present with either bowel preparation were headache, nausea, and vomiting. Conclusion: Split-dose and day-before P/MC provide quality bowel cleansing in adult patients aged %50 years. Compared with 2L PEG+bis, P/MC was better tolerated and provided a safe, low-volume alternative to PEG-based bowel preparations in younger adult patients.
Su1540 Comparison of Colonic Cleansing Efficacy and Tolerability of a Low Volume PEG Preparation to the New Sodium Picosulfate Preparation. Firsts Impressions in Mexico Eduardo Vazquez Mora*, Alberto Farca Belsaguy, Mario Pelaez-Luna, Diego Angulo- Molina, Diego Lozoya Gonzalez, Juan C. Salceda Otero, Fausto Romero Vallejo, Alfonso Balderas Vazquez, Ramon Olavide-Aguilar Endoscopia, Hospital ABC, Mexico, Mexico Background: The diagnostic accuracy of colonoscopy depends on the effectiveness of the cleansing method among other variables. Large and low volume polyethylene glycol (PEG) based solutions, although effective are poorly tolerated due to their unpleasant taste, abdominal discomfort, nausea or vomiting. A new low volume preparation containing sodium picosulfate (SP), magnesium oxide and citric acid has become available. We aimed to compare the colonic cleansing efficacy and tolerability of a low volume PEG preparation to the new SP preparation. Methods: We performed a prospective, randomized, blinded study. All consecutive out-patients undergoing a colonoscopy evaluation were randomly assigned to either a low-volume PEG (nZ25) or SP preparation (nZ25) the day before the colonoscopy, and low-volume PEG (nZ25) or SP preparation (nZ25) in split dose. The endoscopist was blinded to the assigned preparation. Prior to the study, patients filled out a preparation related questionnaire asking about the taste, bloating, abdominal pain, nausea, vomiting, headache and whether they were willing to repeat the preparation or not, in future procedures. Quality of colonic cleansing was scored using the Boston Bowel Preparation Scale (BBPS). Patients with a history of intestinal resection, inflammatory bowel disease, gastrointestinal bleeding, renal failure were excluded. Results: Table shows comparisons on regards demographics, tolerability, side effects and cleansing scores between both preparations. Conclusions: SP preparation was better tolerated considering a better taste, less bloating and willingness to use it in future procedures compared to PEG. According to the BBPS, colon cleansing scores were similar in both groups. Larger studies are needed to verify our results. Potential preparation related serum electrolytes and renal function disorders, need to be evaluated
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Su1537 Impact of Bowel Preparation Type on the Quality of Colonoscopy Jinma Ren*1, Daniel Martin2, Karthik Ragunathan2, Carl Asche1, Michael D. Cashman2, Srinivas R. Puli2, Sonu Dhillon2 1 Medicine, University of Illinois College of Medicine at Peoria, Peoria, IL; 2 OSF Medical Center, Peoria, IL Background and Objective: High-quality bowel preparation is crucial for achieving the goals of colonoscopy. However, choosing a bowel preparation in clinical practice can be a challenge because of the many formulations. This study aims to assess the impact of bowel preparation type on the quality of colonoscopy in a community setting. Methods: A retrospective, observational study was conducted utilizing a colonoscopy screening/surveillance database in central Illinois during the period of January 1, 2010 to March 31, 2014. Patients without bowel preparation assessment were excluded from this study. An ordinal logistic regression model was used to estimate the adjusted impact [odds ratio (OR)] of bowel preparation type on the quality of preparation (excellent, good, fair and poor) based on the Boston Bowel Preparation scale. The association between the time of withdrawal after insertion and the quality of preparation was also examined using a linear model. Results: The half of patients (28,386) was male. The majority (70%) of bowel preparations used polyethylene glycol (PEG), followed by sodium sulfate (21%), sodium phosphate (2%), magnesium sulfate (0.3%) and others. Compared to PEG, magnesium sulfate had a poorer quality of bowel preparations (ORZ0.7, 95% CI 0.4-1.0; p!0.05), whereas the quality of bowel preparation was significantly improved by using sodium sulfate (ORZ6.1, 95% CI 5.4-6.5; p!0.05), sodium phosphate (ORZ2.1, 95% CI 1.8-2.5; p!0.05) and other types (ORZ1.2, 95%CI 1.0-1.6; p!0.05). The rate of examination completion was higher in patients with adequate preparations as compared to those with inadequate preparations (99.4% vs 88.4%, p!0.05). Among patients with a high quality preparation, withdrawal times decreased (median time 911 minutes). Conclusion: When possible, sodium sulfate based preparations should be recommended in the community setting for colonoscopy because of their high quality preparation.
Su1538 The Safety and Feasibility Study of Bowel Cleaning Agents MoviPrepâ Versus Niflecâ for the Patients With Inflammatory Bowel Diseases Undergoing Colonoscopy and Balloon Enteroscopy: a Single Center Randomized Controlled Trial Shingo Kato*, Kazuhito Kani, Taisuke Kobayashi, Ryuichi Yamamoto, Sumiko Nagoshi, Koji Yakabi Saitama Medical Center, Saitama Medical University, Kawagoe City, Japan Background and Aims: MoviprepÒ (MOV) is a bowel cleaning agent with high osmotic pressure. However, it’s not cleared whether MOV could be used safely in patients with active inflammatory bowel diseases (IBDs) because there is a possibility that dehydration aggravates clinical condition of these patients. The aim of this study was to evaluate the safety and cleansing effects of MOV compared to NiflecÒ (NIF) in patients with IBD. Methods: This study was approved by the Institutional Review Board of Saitama Medical Center, and also registered in UMIN (UMIN000010609). Scheduled number of IBD-patients who will be enrolled is 80 patients consisted of 20 active and 20 quiescent UC-patients, and 20 active and 20 quiescent CD-patients. Here we report the results of the interim analysis of this study which consists of 36 UC- and 34 CD- patients. In a single-blinded randomized trial, MOV was compared with NIF in IBD-patients undergoing colonoscopy or balloon enteroscopy from anus. Patients filled out questionnaires grading from 0 (bad) to 5 (good) concerning taste, volume and selection of MOV or NIF in next time examination and discomfort of MOV or NIF. Blinded colonoscopists estimated the efficiency of the cleansing using the cleansing scale grading from 1 (good) to 5 (bad). Primary endpoint was cleansing efficacy of MOV and NIF. Secondary endpoints were blood and urinary osmotic pressure after taking bowel cleansing agents, patient’s acceptability and event-ratio of side effects. Results: About primary endpoint, cleansing efficacy of transverse, descending and sigmoid colon was significantly higher in MOV than NIF group (MOV vs NIF, 1.54 0.70 vs 1.52 0.73 in cecum and ascending colon, pZ0.12;1.14 0.55 vs 1.38 0.62 in transverse colon, pZ0.00054; 1.140.55 vs 1.310.61 in descending colon, pZ0.0026; 1.1710.57 vs 1.1720.47, in sigmoid colon, pZ0.0042; 1.170.57 vs 1.14 0.44 in rectum, pZ0.07). About acceptability, taste- and volume-acceptability were significantly higher in MOV than NIF group (MOV vs NIF, taste, 3.371.03 vs 2.47 0.99, pZ0.0013; volume, 2.891.08 vs 2.260.99, pZ0.046). However, no significance was recognized in the selection of bowel cleaning agent in next time examination (MOV vs NIF, 3.81.05 vs 3.350.85, pZ0.052). Concentration of urine osmotic pressure was significantly higher in MOV group than in NIF group (MOV vs NIF, 630222 vs 509262 Osm, pZ0.045). However, there was no significance between MOV group and NIF group in bloody osmotic pressure (MOV vs NIF, 2834.39 vs 2825.02 Osm, pZ0.88). And also there was no significance between MOV group and NIF group in event-ratio of side effects (MOV vs NIF, 18.9 vs 8.8%, pZ0.88). Conclusion: MOV has good cleansing effects than NIF in IBD patients. And also MOV could be safely used in IBD-patients as well as NIF because of no disturbance in blood osmotic pressure.
AB320 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
Su1539 Safety, Efficacy, and Tolerability of a Low-Volume Sodium Picosulfate/Magnesium Citrate Bowel Preparation in Patients Aged 50 Years and Younger Gerald Bertiger*1, Richard Willey2, Raymond E. Joseph2, Morris Barocas2 1 Hillmont G.I., Flourtown, PA; 2Ferring Pharmaceuticals Inc., Parsippany, NJ Background: Guidelines recommend that individuals begin regular screening for colorectal cancer at age 50; nonetheless, colonoscopies are routinely performed in patients younger than 50 years old. A positive bowel preparation experience may help increase patient adherence to screening guidelines later in life. To address bowel preparation needs in these patients, we performed a post hoc analysis to characterize the efficacy, safety, and tolerability of a low-volume bowel preparation prior to colonoscopy in adults aged %50 years. Methods: Data were obtained from 2 phase 3, randomized, multicenter, assessor-blinded studies that investigated splitdose (Rex DK, et al. Gastrointest Endosc. 2013;78:132) or day-before (Katz P, et al. Am J Gastroenterol. 2013;108:401) dosing of a nonphosphate, dual-action, low-volume preparation containing sodium picosulfate, magnesium oxide, and anhydrous citric acid (P/MC) compared with per labeled dosing of 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (2L PEG+bis) in adults preparing for colonoscopy. In this post hoc analysis, efficacy, safety, and tolerability data were separately analyzed for patients aged %50 years. Overall colon cleansing was rated using a modified Aronchick scale in which cleansing was considered successful if the rating was “excellent” or “good”. Patient tolerability was ascertained on the day of colonoscopy from a 7-item questionnaire administered prior to any preliminary sedation. Safety was assessed by the incidence of adverse events (AEs). Results: A total of 172 patients aged %50 years were included in the intent-to-treat population (ITT) from the study of split-dose P/MC and 133 patients aged %50 years were included from the study of day-before P/MC. Successful bowel cleansing was obtained in 84% of P/MC patients and 89% of P/MC patients in the split-dose and daybefore study, respectively. There was no significant difference in overall colon cleansing between P/MC and 2L PEG+bis in either study in patients aged %50 years. A significantly greater proportion of patients in the P/MC treatment group rated their bowel preparation as “easy”/“very easy” to consume compared with patients in the 2L PEG+bis group (split-dose study, 89% vs 21%; day-before study, 86% vs 27%; P! 0.0001). Overall patient experience was higher in the P/MC group compared with 2L PEG+bis, and a greater proportion of patients indicated they would request P/MC for a future colonoscopy (P!0.01). Combined safety data from both studies show the most common AEs (O2% of patients) present with either bowel preparation were headache, nausea, and vomiting. Conclusion: Split-dose and day-before P/MC provide quality bowel cleansing in adult patients aged %50 years. Compared with 2L PEG+bis, P/MC was better tolerated and provided a safe, low-volume alternative to PEG-based bowel preparations in younger adult patients.
Su1540 Comparison of Colonic Cleansing Efficacy and Tolerability of a Low Volume PEG Preparation to the New Sodium Picosulfate Preparation. Firsts Impressions in Mexico Eduardo Vazquez Mora*, Alberto Farca Belsaguy, Mario Pelaez-Luna, Diego Angulo- Molina, Diego Lozoya Gonzalez, Juan C. Salceda Otero, Fausto Romero Vallejo, Alfonso Balderas Vazquez, Ramon Olavide-Aguilar Endoscopia, Hospital ABC, Mexico, Mexico Background: The diagnostic accuracy of colonoscopy depends on the effectiveness of the cleansing method among other variables. Large and low volume polyethylene glycol (PEG) based solutions, although effective are poorly tolerated due to their unpleasant taste, abdominal discomfort, nausea or vomiting. A new low volume preparation containing sodium picosulfate (SP), magnesium oxide and citric acid has become available. We aimed to compare the colonic cleansing efficacy and tolerability of a low volume PEG preparation to the new SP preparation. Methods: We performed a prospective, randomized, blinded study. All consecutive out-patients undergoing a colonoscopy evaluation were randomly assigned to either a low-volume PEG (nZ25) or SP preparation (nZ25) the day before the colonoscopy, and low-volume PEG (nZ25) or SP preparation (nZ25) in split dose. The endoscopist was blinded to the assigned preparation. Prior to the study, patients filled out a preparation related questionnaire asking about the taste, bloating, abdominal pain, nausea, vomiting, headache and whether they were willing to repeat the preparation or not, in future procedures. Quality of colonic cleansing was scored using the Boston Bowel Preparation Scale (BBPS). Patients with a history of intestinal resection, inflammatory bowel disease, gastrointestinal bleeding, renal failure were excluded. Results: Table shows comparisons on regards demographics, tolerability, side effects and cleansing scores between both preparations. Conclusions: SP preparation was better tolerated considering a better taste, less bloating and willingness to use it in future procedures compared to PEG. According to the BBPS, colon cleansing scores were similar in both groups. Larger studies are needed to verify our results. Potential preparation related serum electrolytes and renal function disorders, need to be evaluated
www.giejournal.org