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Su1548 Comparison of MoviPrep, Pico-Salax and Overnight Fast in Small Bowel Capsule Endoscopy Preparation
Abstracts
Su1546 Serum Magnesium Levels Are Not Affected by Renal Function in Patients Receiving Split-Dose Low-Volume Sodium Picosulfate and Magnesium Citrate Bowel Preparation Gerald Bertiger*1, Edward Jones2, David Dahdal3, Raymond E. Joseph3 1 Hillmont GI, Flourtown, PA; 2Delaware Valley Nephrology and Hypertension Associates, Philadelphia, PA; 3Ferring Pharmaceuticals Inc, Parsippany, NJ Serum magnesium levels are strictly maintained within a normal range of 0.7 to 1.05 mmol/L. Clinical symptoms of hypermagnesemia become evident at approximately 2 mmol/L, beginning with minor manifestations such as nausea, vomiting, and skin flushing, followed by more serious adverse reactions at 3 to 5 mmol/L, such as perturbations in cardiac electrical activity (Onishi. Intern Med. 2006;45:207-210). Many commonly used medications can affect serum magnesium concentrations including diuretics, antihistamines, antibiotics, high doses of calcium, lithium, and magnesium-containing drugs. Magnesium is excreted by the kidneys, making patients with impaired renal function at higher risk for increases in serum magnesium levels. SEE CLEAR I was a phase 3, randomized, multicenter, assessor-blinded study that investigated split-dose administration of a nonphosphate, dual-action, low-volume, orange-flavored preparation containing sodium picosulfate, magnesium oxide, and citric acid (P/MC) compared with conventional dosing of 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (PEG+bisacodyl tablets) in adults preparing for colonoscopy. In this post hoc analysis, serum magnesium levels in patients who received P/MC were analyzed and stratified by renal function (measured by creatinine clearance [CrCl] on the day of colonoscopy). A total of 304 patients in the SEE CLEAR I study received P/MC and were included in the analysis. Patient stratification by CrCl was as follows: R 90 mL/min (69%), 60-89 mL/min (29%), and 30-59 mL/min (2%); patients with CrCl ! 30 mL/min were excluded from the study. On the day of colonoscopy, a majority (87%) of patients had a serum magnesium concentration within the normal range (mean standard deviation, 0.96 0.07 mmol/L; range 0.71.05 mmol/L). Mean magnesium concentration for patients with abnormal levels on the day of colonoscopy was 1.14 0.04 mmol/L (range, 1.10-1.25 mmol/L), just above the upper limit of normal (1.05 mmol/L). Increases in magnesium were transient, and returned to baseline for both the normal and abnormal Mg groups (0.84 .07 mmol/L and 0.91 0.07 mmol/L, respectively) within 24 hours after colonoscopy, regardless of renal function. In conclusion, there was no correlation between renal function and serum magnesium concentration on the day of colonoscopy. There were no adverse events reported associated with elevated serum magnesium levels.
Su1547 A Randomized Controlled Multicenter Trial: a Comparison of 2L Polyethylene Glycol (PEG) With Ascorbic Acid With 4L of PEG for the Safety in Relation With Serum Electrolyte Balances Hong Jun Park*1, Hyun-Soo Kim1, Hee Man Kim1, Gwang Ho Baik2, Yeon Soo Kim2, Sung Chul Park Park3, Hyun IL. Seo4 1 Internal Medicine, Yonsei University Wonju Severance Christian hospital, Wonju city, Republic of Korea; 2Internal Medicine, Hallym unversity, Chuncheon city, Republic of Korea; 3Internal Medicine, Kangwon National University Hospital, Chuncheon city, Republic of Korea; 4Internal Medicine, Ulsan Medical University, Gangneung city, Republic of Korea Ò
Background: Recently, 2L PEG with ascobic acid (2L PEG + Asc, Coolprep , Taejun co.) is available in Korea. Some studies have showned that 2L PEG + Asc had the same efficacy to the traditional 4L PEG for bowel preparation with better tolerance, whereas there were few studies concerning about electrolyte imbalances. We evaluated the efficacy of 2L PEG + Asc compared with conventional 4L PEG solution for bowel preparation, patients tolerance, and safety in relation with serum electrolyte balances through multicenter study. Method: From August 2012 to February 2013, a total of 240 patients were enrolled at 4 tertiary hospitals. All patients were randomly allocated to 2L PEG + Asc group (2L PEG + Asc) or 4L PEG group (PEG group). Before the colonoscopy, the patients were educated to avoid fiber-rich food, fruit with many seeds and some grains for 3 days. Bowel preparations were performed with split same volume schedule in both group. Colonoscopists assessed the bowel preparation by Boston Bowel Preparation Scale (BPPS) without any information of bowel preparation. After colonoscopy procedure, patients filled up the questionnaire for bowel preparation-related symptoms, satisfaction, willingness. In addition, serum electrolytes such as sodium (Na+), potassium (K+), calcium (Ca++), phosphate (P-), serum osmolarity and serum creatinine were evaluated before and after bowel preparation. Results: Among 240 patients, 15 patients were dropped out and 226 patients were finally analyzed. BPPS score were similar (PEG vs. 2L PEG + Asc, 7.1 2.0 vs. 7.0 2.1, p Z 0.601). Bowel preparation related symptoms such as nausea, vomiting, abdominal pain, distension, thirsty, dizziness and numbness were not different between both groups. Patients felt that 2L PEG + Asc tastes better than 4L PEG (PEG vs. 2L PEG + Asc, 16.7% vs. 41.1%, p ! 0.001). Willingness to repeat bowel preparation was higher in 2L PEG + Asc group (PEG vs. 2L PEG + Asc, 59.3% vs. 73.2%, p Z 0.027). Na+ was increased and K+ was decreased significantly after bowel preparation with 4L PEG solution (p!0.001 and pZ0.004, respectively). And
AB210 GASTROINTESTINAL ENDOSCOPY Volume 79, No. 5S : 2014
phosphorus was increased significantly after bowel preparation with 2L PEG + Asc (pZ0.049). However, the changes of values were within normal range. Overall, there were no clinically significant changes of serum electrolytes in both groups. Conclusion: In this multicenter randomized controlled trials, bowel preparation with 2L PEG + Asc was better option than 4L PEG with respect to patient satisfaction and safety especially related to serum electrolytes including Na+ and K+.
Su1548 Comparison of MoviPrep, Pico-Salax and Overnight Fast in Small Bowel Capsule Endoscopy Preparation Erin Rayner-Hartley*, Paula Cramer, Cindy Cheong-Lee, Nazira Chatur, Fergal Donnellan Gastroenterology, University of British Columbia, Vancouver, BC, Canada Background and Objective: The diagnostic yield of small bowel capsule endoscopy (CE) is dependent on effective visualization of the mucosa, which can be affected by fluid and food residue, or bubbles. The optimal bowel preparation prior to small bowel CE has not been established. In addition there are few comparative studies on the different available preparations. The aim of this study was to compare cleanliness and bubble burden following three different preparations prior to small bowel CE. Patients and Methods: Subjects were randomized to one of three preparations prior to CE from December 2011 to July 2013. All examinations were performed using the Olympus Endocapsule. The CE reader was blinded to the preparation type. Cleanliness and bubble burden were graded within the proximal, middle and distal small bowel using a four-point scale: grade 1 Z mucosa free of debris / bubbles, grade 2 Z greater than 75% of mucosa visible, grade 3 Z 50 - 75% of mucosa visible, grade 4 Z less than 50% of mucosa visible. Data are expressed as mean +/- SEM. ANOVA and Fishers exact test were used where appropriate. P values ! 0.05 were considered statistically significant. Results: 124 patients were prospectively enrolled. 25 were excluded because of incomplete small bowel transit. 49 patients took MoviPrep, 37 took Pico-Salax and 38 took a clear liquid diet after lunch on the day before CE, followed by overnight fasting. There was no significant difference in small bowel cleanliness (1.98 +/- 0.09 versus 1.84 +/- 0.08 versus 1.76 +/- 0.08) or small bowel transit (82% versus 84% versus 72%). The bubble burden was significantly higher in the MoviPrep group (1.81 +/- 0.06 versus 1.55 +/- 0.07 versus 1.54 +/- 0.07: p ! 0.05). However this did not result in a significant difference in diagnosis of pathology. Conclusion: There was no significant difference in small bowel cleanliness and ultimately diagnosis of small bowel pathology between the three preparations regimes used in this study. Our study indicates that fasting alone is an adequate preparation regime, which could improve patient tolerability compared to purgative regimes.
Su1549 Colonic Preparation Before Colonoscopy: Evaluation of a New Method With Intracolonic Infusion of Water Compared to Classical Administration of PEG Adrien Sportes, Michel Delvaux*, Jerome Huppertz, Sebastian Suciu, Gerard Gay Hepato-Gastroenterology, CHU Strasbourg, Strasbourg, France Introduction: Bowel cleansing before colonoscopy is currently based upon lavage solutions of polyethylene glycol (PEG) or NaP with large amounts of fluids ingested in a splitted manner. This prospective randomized study compared a PEG protocol with a new method of bowel cleansing based upon infusion of water into the colon at low pressure (PrepSystem, novoGI, Netanya, Israel). Patients and Method: The device for water infusion (novoGI, Lifestream, Austin, TX) is made of a reservoir of water maintained at 37 C. The patient is installed on an adapted seat allowing easy evacuation of water and faeces. Water is infused by gravity through a cannula, into the rectum. Patients with an indication of colonoscopy and no history of colorectal surgery or IBD were randomly assigned to PEG preparation (2L PEG in the evening before and 2L in the morning of colonoscopy) or the Prepsystem. All patients followed a low residue diet for 5 days. In the Prepsystem group, sennosides (Pursennide 80mg, Novartis, Rueil Malmaison, France) were administered in the evening before and patients underwent 2 cleansing cycles, by infusion of 35L tap water each, about one hour before the colonoscopy. Quality of bowel cleansing was assessed with the Boston score by an endoscopist blinded to the preparation type. Boston scores in both groups were compared with a non-parametric test, with a signifcance level of 5%. Results: 70 patients were included (41 males, 5714 y.). Main indications for colonoscopy were colorectal cancer screening (nZ38) and abdominal pain with recent change in bowel habits (nZ28). 37 patients received the Prepsystem and 33, the PEG protocol. Groups were comparable for age, sex and colonoscopy indication. 5 patients were excluded from the analysis after an incomplete colonoscopy for anatomical reasons, preventing calculation of the Boston score: 4 in the Prepsystem and one in the PEG groups. Consequently, 32 patients were analysed in each group. The median Boston score was 7 in both groups, without statistical difference. In the Prepsystem group, the colonoscopy was not completed up to the caecum in 2 patients because of poor cleansing. Mild mucosal tears induced by the cannula were observed in the rectum in 5 patients of the Prepsystem group, Mean duration of the
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Su1546 Serum Magnesium Levels Are Not Affected by Renal Function in Patients Receiving Split-Dose Low-Volume Sodium Picosulfate and Magnesium Citrate Bowel Preparation Gerald Bertiger*1, Edward Jones2, David Dahdal3, Raymond E. Joseph3 1 Hillmont GI, Flourtown, PA; 2Delaware Valley Nephrology and Hypertension Associates, Philadelphia, PA; 3Ferring Pharmaceuticals Inc, Parsippany, NJ Serum magnesium levels are strictly maintained within a normal range of 0.7 to 1.05 mmol/L. Clinical symptoms of hypermagnesemia become evident at approximately 2 mmol/L, beginning with minor manifestations such as nausea, vomiting, and skin flushing, followed by more serious adverse reactions at 3 to 5 mmol/L, such as perturbations in cardiac electrical activity (Onishi. Intern Med. 2006;45:207-210). Many commonly used medications can affect serum magnesium concentrations including diuretics, antihistamines, antibiotics, high doses of calcium, lithium, and magnesium-containing drugs. Magnesium is excreted by the kidneys, making patients with impaired renal function at higher risk for increases in serum magnesium levels. SEE CLEAR I was a phase 3, randomized, multicenter, assessor-blinded study that investigated split-dose administration of a nonphosphate, dual-action, low-volume, orange-flavored preparation containing sodium picosulfate, magnesium oxide, and citric acid (P/MC) compared with conventional dosing of 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (PEG+bisacodyl tablets) in adults preparing for colonoscopy. In this post hoc analysis, serum magnesium levels in patients who received P/MC were analyzed and stratified by renal function (measured by creatinine clearance [CrCl] on the day of colonoscopy). A total of 304 patients in the SEE CLEAR I study received P/MC and were included in the analysis. Patient stratification by CrCl was as follows: R 90 mL/min (69%), 60-89 mL/min (29%), and 30-59 mL/min (2%); patients with CrCl ! 30 mL/min were excluded from the study. On the day of colonoscopy, a majority (87%) of patients had a serum magnesium concentration within the normal range (mean standard deviation, 0.96 0.07 mmol/L; range 0.71.05 mmol/L). Mean magnesium concentration for patients with abnormal levels on the day of colonoscopy was 1.14 0.04 mmol/L (range, 1.10-1.25 mmol/L), just above the upper limit of normal (1.05 mmol/L). Increases in magnesium were transient, and returned to baseline for both the normal and abnormal Mg groups (0.84 .07 mmol/L and 0.91 0.07 mmol/L, respectively) within 24 hours after colonoscopy, regardless of renal function. In conclusion, there was no correlation between renal function and serum magnesium concentration on the day of colonoscopy. There were no adverse events reported associated with elevated serum magnesium levels.
Su1547 A Randomized Controlled Multicenter Trial: a Comparison of 2L Polyethylene Glycol (PEG) With Ascorbic Acid With 4L of PEG for the Safety in Relation With Serum Electrolyte Balances Hong Jun Park*1, Hyun-Soo Kim1, Hee Man Kim1, Gwang Ho Baik2, Yeon Soo Kim2, Sung Chul Park Park3, Hyun IL. Seo4 1 Internal Medicine, Yonsei University Wonju Severance Christian hospital, Wonju city, Republic of Korea; 2Internal Medicine, Hallym unversity, Chuncheon city, Republic of Korea; 3Internal Medicine, Kangwon National University Hospital, Chuncheon city, Republic of Korea; 4Internal Medicine, Ulsan Medical University, Gangneung city, Republic of Korea Ò
Background: Recently, 2L PEG with ascobic acid (2L PEG + Asc, Coolprep , Taejun co.) is available in Korea. Some studies have showned that 2L PEG + Asc had the same efficacy to the traditional 4L PEG for bowel preparation with better tolerance, whereas there were few studies concerning about electrolyte imbalances. We evaluated the efficacy of 2L PEG + Asc compared with conventional 4L PEG solution for bowel preparation, patients tolerance, and safety in relation with serum electrolyte balances through multicenter study. Method: From August 2012 to February 2013, a total of 240 patients were enrolled at 4 tertiary hospitals. All patients were randomly allocated to 2L PEG + Asc group (2L PEG + Asc) or 4L PEG group (PEG group). Before the colonoscopy, the patients were educated to avoid fiber-rich food, fruit with many seeds and some grains for 3 days. Bowel preparations were performed with split same volume schedule in both group. Colonoscopists assessed the bowel preparation by Boston Bowel Preparation Scale (BPPS) without any information of bowel preparation. After colonoscopy procedure, patients filled up the questionnaire for bowel preparation-related symptoms, satisfaction, willingness. In addition, serum electrolytes such as sodium (Na+), potassium (K+), calcium (Ca++), phosphate (P-), serum osmolarity and serum creatinine were evaluated before and after bowel preparation. Results: Among 240 patients, 15 patients were dropped out and 226 patients were finally analyzed. BPPS score were similar (PEG vs. 2L PEG + Asc, 7.1 2.0 vs. 7.0 2.1, p Z 0.601). Bowel preparation related symptoms such as nausea, vomiting, abdominal pain, distension, thirsty, dizziness and numbness were not different between both groups. Patients felt that 2L PEG + Asc tastes better than 4L PEG (PEG vs. 2L PEG + Asc, 16.7% vs. 41.1%, p ! 0.001). Willingness to repeat bowel preparation was higher in 2L PEG + Asc group (PEG vs. 2L PEG + Asc, 59.3% vs. 73.2%, p Z 0.027). Na+ was increased and K+ was decreased significantly after bowel preparation with 4L PEG solution (p!0.001 and pZ0.004, respectively). And
AB210 GASTROINTESTINAL ENDOSCOPY Volume 79, No. 5S : 2014
phosphorus was increased significantly after bowel preparation with 2L PEG + Asc (pZ0.049). However, the changes of values were within normal range. Overall, there were no clinically significant changes of serum electrolytes in both groups. Conclusion: In this multicenter randomized controlled trials, bowel preparation with 2L PEG + Asc was better option than 4L PEG with respect to patient satisfaction and safety especially related to serum electrolytes including Na+ and K+.
Su1548 Comparison of MoviPrep, Pico-Salax and Overnight Fast in Small Bowel Capsule Endoscopy Preparation Erin Rayner-Hartley*, Paula Cramer, Cindy Cheong-Lee, Nazira Chatur, Fergal Donnellan Gastroenterology, University of British Columbia, Vancouver, BC, Canada Background and Objective: The diagnostic yield of small bowel capsule endoscopy (CE) is dependent on effective visualization of the mucosa, which can be affected by fluid and food residue, or bubbles. The optimal bowel preparation prior to small bowel CE has not been established. In addition there are few comparative studies on the different available preparations. The aim of this study was to compare cleanliness and bubble burden following three different preparations prior to small bowel CE. Patients and Methods: Subjects were randomized to one of three preparations prior to CE from December 2011 to July 2013. All examinations were performed using the Olympus Endocapsule. The CE reader was blinded to the preparation type. Cleanliness and bubble burden were graded within the proximal, middle and distal small bowel using a four-point scale: grade 1 Z mucosa free of debris / bubbles, grade 2 Z greater than 75% of mucosa visible, grade 3 Z 50 - 75% of mucosa visible, grade 4 Z less than 50% of mucosa visible. Data are expressed as mean +/- SEM. ANOVA and Fishers exact test were used where appropriate. P values ! 0.05 were considered statistically significant. Results: 124 patients were prospectively enrolled. 25 were excluded because of incomplete small bowel transit. 49 patients took MoviPrep, 37 took Pico-Salax and 38 took a clear liquid diet after lunch on the day before CE, followed by overnight fasting. There was no significant difference in small bowel cleanliness (1.98 +/- 0.09 versus 1.84 +/- 0.08 versus 1.76 +/- 0.08) or small bowel transit (82% versus 84% versus 72%). The bubble burden was significantly higher in the MoviPrep group (1.81 +/- 0.06 versus 1.55 +/- 0.07 versus 1.54 +/- 0.07: p ! 0.05). However this did not result in a significant difference in diagnosis of pathology. Conclusion: There was no significant difference in small bowel cleanliness and ultimately diagnosis of small bowel pathology between the three preparations regimes used in this study. Our study indicates that fasting alone is an adequate preparation regime, which could improve patient tolerability compared to purgative regimes.
Su1549 Colonic Preparation Before Colonoscopy: Evaluation of a New Method With Intracolonic Infusion of Water Compared to Classical Administration of PEG Adrien Sportes, Michel Delvaux*, Jerome Huppertz, Sebastian Suciu, Gerard Gay Hepato-Gastroenterology, CHU Strasbourg, Strasbourg, France Introduction: Bowel cleansing before colonoscopy is currently based upon lavage solutions of polyethylene glycol (PEG) or NaP with large amounts of fluids ingested in a splitted manner. This prospective randomized study compared a PEG protocol with a new method of bowel cleansing based upon infusion of water into the colon at low pressure (PrepSystem, novoGI, Netanya, Israel). Patients and Method: The device for water infusion (novoGI, Lifestream, Austin, TX) is made of a reservoir of water maintained at 37 C. The patient is installed on an adapted seat allowing easy evacuation of water and faeces. Water is infused by gravity through a cannula, into the rectum. Patients with an indication of colonoscopy and no history of colorectal surgery or IBD were randomly assigned to PEG preparation (2L PEG in the evening before and 2L in the morning of colonoscopy) or the Prepsystem. All patients followed a low residue diet for 5 days. In the Prepsystem group, sennosides (Pursennide 80mg, Novartis, Rueil Malmaison, France) were administered in the evening before and patients underwent 2 cleansing cycles, by infusion of 35L tap water each, about one hour before the colonoscopy. Quality of bowel cleansing was assessed with the Boston score by an endoscopist blinded to the preparation type. Boston scores in both groups were compared with a non-parametric test, with a signifcance level of 5%. Results: 70 patients were included (41 males, 5714 y.). Main indications for colonoscopy were colorectal cancer screening (nZ38) and abdominal pain with recent change in bowel habits (nZ28). 37 patients received the Prepsystem and 33, the PEG protocol. Groups were comparable for age, sex and colonoscopy indication. 5 patients were excluded from the analysis after an incomplete colonoscopy for anatomical reasons, preventing calculation of the Boston score: 4 in the Prepsystem and one in the PEG groups. Consequently, 32 patients were analysed in each group. The median Boston score was 7 in both groups, without statistical difference. In the Prepsystem group, the colonoscopy was not completed up to the caecum in 2 patients because of poor cleansing. Mild mucosal tears induced by the cannula were observed in the rectum in 5 patients of the Prepsystem group, Mean duration of the
www.giejournal.org