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Creation and Validation of a Novel Ex-Vivo Colonoscopy Simulation Model
Abstracts
S1428 Use of Self-Expandable Polyflex Stents for Palliation of Esophageal Strictures and Closure of Gastrointestinal Fistulas Tony E. Yusuf, Christopher C. Thompson, John M. Poneros, John R. Saltzman, Richard S. Johannes, David L. Carr-Locke
S1430 Creation and Validation of a Novel Ex-Vivo Colonoscopy Simulation Model Robert E. Sedlack
Background: The Polyflex stent (Boston Scientific, Natick, MA) is a removable selfexpanding plastic stent that is approved for benign esophageal strictures refractory to dilation and for palliation of inoperable malignant strictures including closure of tracheo-esophageal fistula. We report our experience with the Polyflex stent in these conditions. Patients and Methods: This is a retrospective review of all cases treated in our Endoscopy Center with a Polyflex stent between December 2003 and October 2005. Medical records, endoscopy reports, radiographs and pathology were reviewed. Results: Twenty-three patients (12 females and 11 males; mean age, 61.6 years; range, 36-85 years) were treated with Polyflex stents during the study period. The patients were followed up for a mean of 5.8 months, range 1-19 months. The indications for stent placement were benign esophageal stricture (n Z 10), malignant esophageal stricture (n Z 7), recto-sigmoid stricture (n Z 1), tracheo-esophageal fistula (n Z 1), gastro-gastric fistula (n Z 1), esophago-gastric fistula (n Z 1), gastro-peritoneal fistula (n Z 1), and sigmoid colon-cutaneous fistula (n Z 1). Benign esophageal strictures were dilated endoscopically in a mean of 1.9 sessions, range 1-15 sessions, prior to consideration of Polyflex stent placement. Stent insertion was technically successful in 22/23 (96%). The stents were 9, 12 and 15 cm long, shaft diameter were 16, 18, and 21 mm with a proximal end diameter of 20, 23, and 25 mm, respectively. They were left in place for a mean of 22.9 days (range 2-90 days) before removal. Stent occlusion occurred in 2/23 (8.7%) at 30 and 80 days and migration in 9/23 (39.1%) at a mean of 25.2 days (range 3-60 days). Restenting was performed in 5 (21.7%). Post-procedural vomiting and chest pain were reported by 1 and 3 patients respectively. Of the 18 patients with dysphagia, 4 reported good oral intake post stent placement, 6 fair, and 8 poor during stent therapy and in the ten benign strictures all reported improvement. Fistula closure was achieved in the patient with gastro-peritoneal fistula. Conclusions: The self-expandable Polyflex plastic stent is a reasonable alternative treatment option for inoperable esophageal strictures and gastrointestinal fistulas with high technical success rate. The stents are safe and fairly effective. These results need to be verified by randomized controlled trials which have been initiated.
Purpose: The purpose is to provide initial validation of a novel simulation model’s realism, capability to stratify endoscopists based on levels experience and its ability to act as a surrogate tool to assess patient-based endoscopy skills. Methods: 39 endoscopists (13 Staff, 13 second year fellows and 13 novices) each performed a colonoscopy on a new simulation model comprised of a harvested bovine colon laid out on a specially designed platform. The median time required to reach specific landmarks by each group were compared using the Wilcox rank sum test. Additionally, the degree of correlation between each individual’s simulation and median patient-based intubation times was calculated for the staff and fellow groups using the Spearman’s correlation. Staff endoscopist also completed a 13 question survey examining different aspects of the model’s realism as compared to human colonoscopy. Scores were based on a 7 point Likert scale (1 Z very unrealistic, 4 Z neutral, 7 Z very realistic) Results: Each group outperformed the less experienced groups in all parameters evaluated. Specifically, median cecal intubation times were: Staff 226 Sec (IQR Z 179-273), Fellows 340 Sec (282-568), and Novices 1027 sec (970-1122) (p ! 0.05). Median total procedure times on the model were: Staff 468 sec (416-501), Fellows 527 Sec (459-824), and Novices 1350 Sec (1318-1428) (p ! 0.05). The Spearman correlation of simulated cecal intubation times compared to median patient-based intubation time was r Z 0.764 (p ! 0.0001). Median model realism evaluation scores were favorable for nearly all parameters evaluated. Realism of the mucosa appearance, endoscopic view and paradoxical motion parameters scored the highest with a median score of 6 (IQR 5-6). All other parameters had a favorable score of 5 save for haustra realism and procedural difficulty both of which received a median score of 3. The median score for overall simulation realism was 5 (5-6). Conclusions: Overall, this model possesses a favorable degree of realism. Additionally, the model was able to easily differentiate users based on their level of colonoscopy experience. More impressive however is the strong correlation between individual’s simulated intubation times and actual patient-based colonoscopy data. In light of these findings, we speculate that this model could be effective in objectively monitoring a trainee’s progress during training. Furthermore, this model could potentially be standardized with minimum thresholds for competency and used for summative skills assessments. Based on these encouraging initial results, further model refinement and validation for competency assessment is warranted.
S1429 Prone Position Reduces Colonoscopic Cecal Intubation Time Shivakumar Vignesh
S1431 Randomized Controlled Study On Optimal Air Insufflation Level During Colonoscopy Atsuo Yamada, Hirotsugu Watabe, Makoto Okamoto, Yutaka Yamaji, Keiji Ogura, Shintaro Kondo, Miki Ohta, Takafumi Sugimoto, Takao Kawabe, Masao Omata
Hypothesis: Colonoscopy performed in the prone position may improve procedure efficiency by providing abdominal compression. Aim: To determine if starting colonoscopy with the patient in the prone position (group 1) as compared to the left lateral position (group 2) will affect cecal intubation time (CIT). Methods: This is a randomized controlled trial of 100 adult male outpatients undergoing colonoscopy. Patients with lung disease requiring oxygen, severe heart failure, and tense ascites were excluded. Patients were first randomized to the left lateral or prone positions by computerized block randomization. This was revealed only to an assistant in charge of data collection who informed the endoscopist of the patient’s assignment after informed consent was signed, prior to colonoscopy. All patients received intravenous midazolam and fentanyl for sedation. The following were recorded as a function of time: change in patient position and use of abdominal pressure. A patient satisfaction score and their recall of changes in their position during colonoscopy and use of abdominal pressure was obtained by a written survey completed 24 hours post procedure using a Likert scale. Results: The two groups were evenly matched for age, major comorbidity, past abdominal surgery, and abdominal hernias. The two-tailed t-test was used to compare the mean CIT and sedation dose. The mean CIT was 3.7 minutes in group 1 and 8.6 minutes in group 2 (P ! 0.001). The total colonoscopy time was 12 minutes in group 1 and 20 minutes in group 2 (P ! 0.001). The Chi-Square test was used to compare need for abdominal pressure and changes in position in both groups. Abdominal pressure was required in 4% of group 1 and 62%of group 2 (P ! 0.001). There was a change in the patient’s position in 4% in group 1 and 64% of group 2 (P ! 0.001). There were no immediate or delayed complications verified by talking to the patient the day after the procedure. Patient satisfaction was equally high (5/5 in 97% of patients) in both groups using a Likert scale. 90% of the patients remembered their colonoscopy position correctly and 38% recalled use of abdominal pressure or changes in their position during colonoscopy and there was no difference between the groups. Conclusions: Colonoscopy with the patient in the prone position is safe, well tolerated and significantly reduced CIT as compared to the left lateral position. There was a reduced need for abdominal pressure or a change in patient position with the prone position as compared to the left lateral. Additional studies need to be done to determine if this should become an endoscopic standard.
AB106 GASTROINTESTINAL ENDOSCOPY Volume 63, No. 5 : 2006
Background: Colonoscopy often carries discomfort for the patient and difficulty for the endoscopist. Several features of patients, such as female gender, postabdominal surgery and diverticulosis, are identified as the factors that make colonoscopy painful and difficult. Insufflated air volume may be theoretically related to patient’s pain and difficulty of colonoscopy. Recent endoscopic apparatus has the function to regulate air insufflation levels. In the present study, we aimed to evaluate the efficacy of each air insufflation level. Methods: Between August and November 2005, 444 patients undergoing colonoscopy were candidates for the study. Of those, 7 with gastrointestinal bleeding, 17 with history of colorectal surgery, 10 with inflammatory bowel disease were excluded. EVIS CLVU-40D (Olympus Co., Tokyo, Japan) was used as a videoendoscopic system. This apparatus provides 3 levels of air insufflation; High, Medium and Low. Four hundred ten patients were randomly assigned to the three groups according to air insufflation levels. Before the procedure, an interview was performed to obtain clinical features of patient including age, gender, body mass index (BMI), and history of abdominal surgery. Cecal intubation time and colonoscopic findings were recorded immediately after the procedure. Patients were interviewed again about the pain graded between 1 and 10. Primary endpoint was cecal intubation rate within 15 minutes. Secondary outcome were time to reach the cecum and pain score. Results: Finally, 397 patients (mean age 61.7, male/female; 245/152) completed the trial. No complication occurred. The number of patients was 131 in High group, 140 in Medium group and 126 in Low group. There were no differences in age, gender, BMI, or proportion of the history of abdominal surgery among three groups. Low group showed a lower rate of intubation within 15 minutes than Medium or High groups; 39.7% in Low group, 59.3% in Medium, 64.1% in High (p Z 0.0002). As compared with High group, odds ratio of Low group was calculated to be 0.31 (95%CI 0.17-0.54, p Z 0.0003) by multivariate analysis adjusted for age, gender, BMI, and history of abdominal surgery. Cecal intubation time was 17.5 min. in Low group, 13.5 min. in Medium and 12.9 min. in High. Low group required longer time to intubate than two other groups (P Z 0.0006). There was no difference in pain scores between three groups. Conclusion: Medium or High level of air insufflation should be employed for total colonoscopy.
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S1428 Use of Self-Expandable Polyflex Stents for Palliation of Esophageal Strictures and Closure of Gastrointestinal Fistulas Tony E. Yusuf, Christopher C. Thompson, John M. Poneros, John R. Saltzman, Richard S. Johannes, David L. Carr-Locke
S1430 Creation and Validation of a Novel Ex-Vivo Colonoscopy Simulation Model Robert E. Sedlack
Background: The Polyflex stent (Boston Scientific, Natick, MA) is a removable selfexpanding plastic stent that is approved for benign esophageal strictures refractory to dilation and for palliation of inoperable malignant strictures including closure of tracheo-esophageal fistula. We report our experience with the Polyflex stent in these conditions. Patients and Methods: This is a retrospective review of all cases treated in our Endoscopy Center with a Polyflex stent between December 2003 and October 2005. Medical records, endoscopy reports, radiographs and pathology were reviewed. Results: Twenty-three patients (12 females and 11 males; mean age, 61.6 years; range, 36-85 years) were treated with Polyflex stents during the study period. The patients were followed up for a mean of 5.8 months, range 1-19 months. The indications for stent placement were benign esophageal stricture (n Z 10), malignant esophageal stricture (n Z 7), recto-sigmoid stricture (n Z 1), tracheo-esophageal fistula (n Z 1), gastro-gastric fistula (n Z 1), esophago-gastric fistula (n Z 1), gastro-peritoneal fistula (n Z 1), and sigmoid colon-cutaneous fistula (n Z 1). Benign esophageal strictures were dilated endoscopically in a mean of 1.9 sessions, range 1-15 sessions, prior to consideration of Polyflex stent placement. Stent insertion was technically successful in 22/23 (96%). The stents were 9, 12 and 15 cm long, shaft diameter were 16, 18, and 21 mm with a proximal end diameter of 20, 23, and 25 mm, respectively. They were left in place for a mean of 22.9 days (range 2-90 days) before removal. Stent occlusion occurred in 2/23 (8.7%) at 30 and 80 days and migration in 9/23 (39.1%) at a mean of 25.2 days (range 3-60 days). Restenting was performed in 5 (21.7%). Post-procedural vomiting and chest pain were reported by 1 and 3 patients respectively. Of the 18 patients with dysphagia, 4 reported good oral intake post stent placement, 6 fair, and 8 poor during stent therapy and in the ten benign strictures all reported improvement. Fistula closure was achieved in the patient with gastro-peritoneal fistula. Conclusions: The self-expandable Polyflex plastic stent is a reasonable alternative treatment option for inoperable esophageal strictures and gastrointestinal fistulas with high technical success rate. The stents are safe and fairly effective. These results need to be verified by randomized controlled trials which have been initiated.
Purpose: The purpose is to provide initial validation of a novel simulation model’s realism, capability to stratify endoscopists based on levels experience and its ability to act as a surrogate tool to assess patient-based endoscopy skills. Methods: 39 endoscopists (13 Staff, 13 second year fellows and 13 novices) each performed a colonoscopy on a new simulation model comprised of a harvested bovine colon laid out on a specially designed platform. The median time required to reach specific landmarks by each group were compared using the Wilcox rank sum test. Additionally, the degree of correlation between each individual’s simulation and median patient-based intubation times was calculated for the staff and fellow groups using the Spearman’s correlation. Staff endoscopist also completed a 13 question survey examining different aspects of the model’s realism as compared to human colonoscopy. Scores were based on a 7 point Likert scale (1 Z very unrealistic, 4 Z neutral, 7 Z very realistic) Results: Each group outperformed the less experienced groups in all parameters evaluated. Specifically, median cecal intubation times were: Staff 226 Sec (IQR Z 179-273), Fellows 340 Sec (282-568), and Novices 1027 sec (970-1122) (p ! 0.05). Median total procedure times on the model were: Staff 468 sec (416-501), Fellows 527 Sec (459-824), and Novices 1350 Sec (1318-1428) (p ! 0.05). The Spearman correlation of simulated cecal intubation times compared to median patient-based intubation time was r Z 0.764 (p ! 0.0001). Median model realism evaluation scores were favorable for nearly all parameters evaluated. Realism of the mucosa appearance, endoscopic view and paradoxical motion parameters scored the highest with a median score of 6 (IQR 5-6). All other parameters had a favorable score of 5 save for haustra realism and procedural difficulty both of which received a median score of 3. The median score for overall simulation realism was 5 (5-6). Conclusions: Overall, this model possesses a favorable degree of realism. Additionally, the model was able to easily differentiate users based on their level of colonoscopy experience. More impressive however is the strong correlation between individual’s simulated intubation times and actual patient-based colonoscopy data. In light of these findings, we speculate that this model could be effective in objectively monitoring a trainee’s progress during training. Furthermore, this model could potentially be standardized with minimum thresholds for competency and used for summative skills assessments. Based on these encouraging initial results, further model refinement and validation for competency assessment is warranted.
S1429 Prone Position Reduces Colonoscopic Cecal Intubation Time Shivakumar Vignesh
S1431 Randomized Controlled Study On Optimal Air Insufflation Level During Colonoscopy Atsuo Yamada, Hirotsugu Watabe, Makoto Okamoto, Yutaka Yamaji, Keiji Ogura, Shintaro Kondo, Miki Ohta, Takafumi Sugimoto, Takao Kawabe, Masao Omata
Hypothesis: Colonoscopy performed in the prone position may improve procedure efficiency by providing abdominal compression. Aim: To determine if starting colonoscopy with the patient in the prone position (group 1) as compared to the left lateral position (group 2) will affect cecal intubation time (CIT). Methods: This is a randomized controlled trial of 100 adult male outpatients undergoing colonoscopy. Patients with lung disease requiring oxygen, severe heart failure, and tense ascites were excluded. Patients were first randomized to the left lateral or prone positions by computerized block randomization. This was revealed only to an assistant in charge of data collection who informed the endoscopist of the patient’s assignment after informed consent was signed, prior to colonoscopy. All patients received intravenous midazolam and fentanyl for sedation. The following were recorded as a function of time: change in patient position and use of abdominal pressure. A patient satisfaction score and their recall of changes in their position during colonoscopy and use of abdominal pressure was obtained by a written survey completed 24 hours post procedure using a Likert scale. Results: The two groups were evenly matched for age, major comorbidity, past abdominal surgery, and abdominal hernias. The two-tailed t-test was used to compare the mean CIT and sedation dose. The mean CIT was 3.7 minutes in group 1 and 8.6 minutes in group 2 (P ! 0.001). The total colonoscopy time was 12 minutes in group 1 and 20 minutes in group 2 (P ! 0.001). The Chi-Square test was used to compare need for abdominal pressure and changes in position in both groups. Abdominal pressure was required in 4% of group 1 and 62%of group 2 (P ! 0.001). There was a change in the patient’s position in 4% in group 1 and 64% of group 2 (P ! 0.001). There were no immediate or delayed complications verified by talking to the patient the day after the procedure. Patient satisfaction was equally high (5/5 in 97% of patients) in both groups using a Likert scale. 90% of the patients remembered their colonoscopy position correctly and 38% recalled use of abdominal pressure or changes in their position during colonoscopy and there was no difference between the groups. Conclusions: Colonoscopy with the patient in the prone position is safe, well tolerated and significantly reduced CIT as compared to the left lateral position. There was a reduced need for abdominal pressure or a change in patient position with the prone position as compared to the left lateral. Additional studies need to be done to determine if this should become an endoscopic standard.
AB106 GASTROINTESTINAL ENDOSCOPY Volume 63, No. 5 : 2006
Background: Colonoscopy often carries discomfort for the patient and difficulty for the endoscopist. Several features of patients, such as female gender, postabdominal surgery and diverticulosis, are identified as the factors that make colonoscopy painful and difficult. Insufflated air volume may be theoretically related to patient’s pain and difficulty of colonoscopy. Recent endoscopic apparatus has the function to regulate air insufflation levels. In the present study, we aimed to evaluate the efficacy of each air insufflation level. Methods: Between August and November 2005, 444 patients undergoing colonoscopy were candidates for the study. Of those, 7 with gastrointestinal bleeding, 17 with history of colorectal surgery, 10 with inflammatory bowel disease were excluded. EVIS CLVU-40D (Olympus Co., Tokyo, Japan) was used as a videoendoscopic system. This apparatus provides 3 levels of air insufflation; High, Medium and Low. Four hundred ten patients were randomly assigned to the three groups according to air insufflation levels. Before the procedure, an interview was performed to obtain clinical features of patient including age, gender, body mass index (BMI), and history of abdominal surgery. Cecal intubation time and colonoscopic findings were recorded immediately after the procedure. Patients were interviewed again about the pain graded between 1 and 10. Primary endpoint was cecal intubation rate within 15 minutes. Secondary outcome were time to reach the cecum and pain score. Results: Finally, 397 patients (mean age 61.7, male/female; 245/152) completed the trial. No complication occurred. The number of patients was 131 in High group, 140 in Medium group and 126 in Low group. There were no differences in age, gender, BMI, or proportion of the history of abdominal surgery among three groups. Low group showed a lower rate of intubation within 15 minutes than Medium or High groups; 39.7% in Low group, 59.3% in Medium, 64.1% in High (p Z 0.0002). As compared with High group, odds ratio of Low group was calculated to be 0.31 (95%CI 0.17-0.54, p Z 0.0003) by multivariate analysis adjusted for age, gender, BMI, and history of abdominal surgery. Cecal intubation time was 17.5 min. in Low group, 13.5 min. in Medium and 12.9 min. in High. Low group required longer time to intubate than two other groups (P Z 0.0006). There was no difference in pain scores between three groups. Conclusion: Medium or High level of air insufflation should be employed for total colonoscopy.
www.giejournal.org