A multicenter, prospective, inpatient feasibility study to evaluate the use of an intra-colonoscopy cleansing device to optimize colon preparation in hospitalized patients: the REDUCE study

Background High quality bowel preparation prior to colonoscopy can be difficult to achieve in the inpatient setting. Hospitalized patients are at risk for extended hospital stays and low diagnostic yield due to inadequate bowel preparation. The Pure-Vu System is a novel device intended to fit over existing colonoscopes to improve intra-colonoscopy bowel preparation. The objective of the REDUCE study was to conduct the first inpatient study to evaluate optimization of bowel preparation quality following overnight preparation when using the Pure-Vu System during colonoscopy. Methods This multicenter, prospective feasibility study enrolled hospitalized subjects undergoing colonoscopy. Subjects recorded the clarity of their last bowel movement using a 5-point scale prior to colonoscopy. After one night of preparation, all enrolled subjects underwent colonoscopy utilizing the Pure-Vu System. The primary endpoint was improvement of colon cleanliness from baseline to post-cleansing with the Pure-Vu System as assessed by the improvement in Boston Bowel Preparation Scale (BBPS). An exploratory analysis was conducted to assess whether the clarity of the last bowel movement could predict inadequate bowel preparation. Results Ninety-four subjects were included. BBPS analyses showed significant improvements in bowel preparation quality across all evaluable colon segments after cleansing with Pure-Vu, including left colon (1.74 vs 2.89; p < 0.0001), transverse colon (1.74 vs 2.91; p < 0.0001), and the right colon (1.41 vs 2.88; p < 0.0001). Prior to Pure-Vu, adequate cleansing (BBPS scores of ≥ 2) were reported in 60%, 62%, and 47% for the left colon, transverse colon, and right colon segments, respectively. After intra-colonoscopy cleansing with the Pure-Vu System, adequate colon preparation was reported in 100%, 99%, and 97% of the left colon, transverse colon, and right colon segments, respectively. Subjects with lower bowel movement clarity scores were more likely to have inadequate bowel preparation prior to cleansing with Pure-Vu. Conclusions In this feasibility study, the Pure-Vu System appears to be effective in significantly improving bowel preparation quality in hospitalized subjects undergoing colonoscopy. Clarity of last bowel movement may be useful indicator in predicting poor bowel preparation. Larger studies powered to evaluate clinical outcomes, hospital costs, and blinded BBPS assessments are required to evaluate the significance of these findings. Trial registration Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System (NCT03503162).

Use of U-Net Convolutional Neural Networks for Automated Segmentation of Fecal Material to Objective Evaluation of Bowel Preparation Quality in Colonoscopy (Preprint)

BACKGROUND Adequate bowel cleansing is important for a complete examination of the colon mucosa during colonoscopy. Current bowel cleansing evaluation scales are subjective with a wide variation in consistency among physicians and low reported rate. Artificial intelligence (AI) has been increasingly used in endoscopy. OBJECTIVE We aim to use machine learning to develop a fully automatic segmentation method to mark the fecal residue-coated mucosa for objective evaluation of the adequacy of colon preparation. METHODS Colonoscopy videos were retrieved from a video data cohort and transferred to qualified images, which were randomly divided into training, validation and verification datasets. The fecal residue was manually segmented by skilled technicians. Deep learning model based on the U-Net convolutional network architecture was developed to perform automatic segmentation. TheA total of 10,118 qualified images from 119 videos were captured, and labelled manually. The model averaged 0.3634 seconds to segmentate one image automatically. The models produced a strong high-overlap area with manual segmentation to 94.7% ± 0.67% with an intersection over union (IOU) of 0.607 ± 0.17. The area predicted by our AI model correlated well with the area measured manually (r=0.915, p<0.001). The AI system can be applied real-time to qualitatively and quantitatively display the mucosa covered by fecal residue. performance of the automatic segmentation was evaluated on the overlap area with the manual segmentation. RESULTS A total of 10,118 qualified images from 119 videos were captured, and labelled manually. The model averaged 0.3634 seconds to segmentate one image automatically. The models produced a strong high-overlap area with manual segmentation to 94.7% ± 0.67% with an intersection over union (IOU) of 0.607 ± 0.17. The area predicted by our AI model correlated well with the area measured manually (r=0.915, p<0.001). The AI system can be applied real-time to qualitatively and quantitatively display the mucosa covered by fecal residue. CONCLUSIONS We used machine learning to establish a fully automatic segmentation method to rapidly and accurately mark the fecal residue-coated mucosa for objective evaluation of colon preparation.

Evaluating lubiprostone for effective bowel preparation before colonoscopy

Background Colon preparation is a fundamental step for performing a successful colonoscopy. We aimed to evaluate the effectiveness of administering lubiprostone (LB) added to a single dose of oral polyethylene glycol (PEG) solution in achieving satisfactory colon cleanliness and decreasing the side effects. Results One-hundred percent of the control group patients reported that the experienced taste was worse than expected, while in the intervention group half of the patients (50%) said that the taste was natural and 48% experienced taste worse than expected (p<0.0001). Regarding Boston bowel preparation scale (BBPS), there was a significant difference in the overall Boston scale (p=0.02) with more efficacy in the intervention group as 66% of patients in the intervention group had good bowel preparation (5–7) and 24% excellent preparation (8–9). On the other hand, the overall Boston scale in the control group showed that 54% of patients were between 5 and 7, and only 16% of patients had overall Boston scale 8–9. In terms of the side effects of the preparation in both arms, the majority of cases in the intervention arm did not complain of any side effects (78%), while the majority of the complaints were vomiting in 16% of the intervention cases. Conclusion The current evidence suggested that adding LB to the colon preparation significantly improved the tolerability and efficacy.

Effect of Bowel Preparation Volume in Inpatient Colonoscopy. Results of a Prospective, Randomized, Comparative Pilot Study

Background: Inpatient status has been shown to be a predictor of poor bowel preparation for colonoscopy; however, the optimal bowel preparation regimen for hospitalized patients is unknown. Our aim was to compare the efficacy of bowel preparation volume size in hospitalized patients undergoing inpatient colonoscopy.Methods: This prospective, single blinded (endoscopist), randomized controlled trial was conducted as a pilot study at a tertiary referral medical center. Hospitalized patients undergoing inpatient colonoscopy were assigned randomly to receive a high, medium, or low-volume preparation. Data collection included colon preparation quality, based on the Boston Bowel Preparation Scale, and a questionnaire given to all subjects evaluating the ability to completely finish bowel preparation and adverse effects (unpleasant taste, nausea, and vomiting). Results: Twenty-five colonoscopies were performed in 25 subjects. Patients who received low-volume preparation averaged a higher mean total BBPS (7.4, SD 1.62), in comparison to patients who received high-volume (7.0, SD 1.41) and medium-volume prep (6.9, SD 1.55), P = 0.77. When evaluating taste a higher score meant worse taste. The low-volume group scored unpleasant taste as 0.6 (0.74), while the high-volume group gave unpleasant taste a score of 2.2 (0.97) and the medium-volume group gave a score of 2.1 (1.36), P < 0.01.Conclusion: In this pilot study we found that low-volume colon preparation may be preferred in the inpatient setting due its better rate of tolerability and comparable bowel cleanliness when compared to larger volume preparation, although we cannot overreach any definitive conclusion. Further more robust studies are required to confirm these findings.Trial registration: The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies. Trial registration: NCT01978509 (terminated). Retrospectively registered on November 07, 2013.

Effect of Bowel Preparation Volume in Inpatient Colonoscopy. Results of a Prospective, Randomized, Comparative Pilot Study

Background: Inpatient status has been shown to be a predictor of poor bowel preparation for colonoscopy; however, the optimal bowel preparation regimen for hospitalized patients is unknown. Our aim was to compare the efficacy of bowel preparation volume size in hospitalized patients undergoing inpatient colonoscopy.Methods: This prospective, single blinded (endoscopist), randomized controlled trial was conducted as a pilot study at a tertiary referral medical center. Hospitalized patients undergoing inpatient colonoscopy were assigned randomly to receive a high, medium, or low-volume preparation. Data collection included colon preparation quality, based on the Boston Bowel Preparation Scale, and a questionnaire given to all subjects evaluating the ability to completely finish bowel preparation and adverse effects (unpleasant taste, nausea, and vomiting). Results: Twenty-five colonoscopies were performed in 25 subjects. Patients who received low-volume preparation averaged a higher mean total BBPS (7.4, SD 1.62), in comparison to patients who received high-volume (7.0, SD 1.41) and medium-volume prep (6.9, SD 1.55), P = 0.77. When evaluating taste a higher score meant worse taste. The low-volume group scored unpleasant taste as 0.6 (0.74), while the high-volume group gave unpleasant taste a score of 2.2 (0.97) and the medium-volume group gave a score of 2.1 (1.36), P < 0.01.Conclusion: In this pilot study we found that low-volume colon preparation may be preferred in the inpatient setting due its better rate of tolerability and comparable bowel cleanliness when compared to larger volume preparation, although we cannot overreach any definitive conclusion. Further more robust studies are required to confirm these findings.Trial registration: The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies. Trial registration: NCT01978509 (terminated). Retrospectively registered on November 07, 2013.

Effect of Bowel Preparation Volume in Inpatient Colonoscopy. Results of a Prospective, Randomized, Comparative Pilot Study

Background: Inpatient status has been shown to be a predictor of poor bowel preparation for colonoscopy; however, the optimal bowel preparation regimen for hospitalized patients is unknown. Our aim was to compare the efficacy of bowel preparation volume size in hospitalized patients undergoing inpatient colonoscopy.Methods: This prospective, single blinded (endoscopist), randomized controlled trial was conducted as a pilot study at a tertiary referral medical center. Hospitalized patients undergoing inpatient colonoscopy were assigned randomly to receive a high, medium, or low-volume preparation. Data collection included colon preparation quality, based on the Boston Bowel Preparation Scale, and a questionnaire given to all subjects evaluating the ability to completely finish bowel preparation and adverse effects (unpleasant taste, nausea, and vomiting). Results: Twenty-five colonoscopies were performed in 25 subjects. Patients who received low-volume preparation averaged a higher mean total BBPS (7.4, SD 1.62), in comparison to patients who received high-volume (7.0, SD 1.41) and medium-volume prep (6.9, SD 1.55), P = 0.77. When evaluating taste a higher score meant worse taste. The low-volume group scored unpleasant taste as 0.6 (0.74), while the high-volume group gave unpleasant taste a score of 2.2 (0.97) and the medium-volume group gave a score of 2.1 (1.36), P < 0.01.Conclusion: In this pilot study we found that low-volume colon preparation may be preferred in the inpatient setting due its better rate of tolerability and comparable bowel cleanliness when compared to larger volume preparation, although we cannot overreach any definitive conclusion. Further more robust studies are required to confirm these findings.Trial registration: clinicaltrials.gov NCT01978509

Effect of Bowel Preparation Volume in Inpatient Colonoscopy. Results of a Prospective, Randomized, Comparative Pilot Study

Background: Inpatient status has been shown to be a predictor of poor bowel preparation for colonoscopy; however, the optimal bowel preparation regimen for hospitalized patients is unknown. Our aim was to compare the efficacy of bowel preparation volume size in hospitalized patients undergoing inpatient colonoscopy. Methods: This prospective, single blinded (endoscopist), randomized controlled trial was conducted as a pilot study at a tertiary referral medical center. Hospitalized patients undergoing inpatient colonoscopy were assigned randomly to receive a high, medium, or low-volume preparation. Data collection included colon preparation quality, based on the Boston Bowel Preparation Scale, and a questionnaire given to all subjects evaluating the ability to completely finish bowel preparation and adverse effects (unpleasant taste, nausea, and vomiting). Results: Twenty-five colonoscopies were performed in 25 subjects. Patients who received low-volume preparation averaged a higher mean total BBPS (7.4, SD 1.62), in comparison to patients who received high-volume (7.0, SD 1.41) and medium-volume prep (6.9, SD 1.55), P = 0.77. When evaluating taste a higher score meant worse taste. The low-volume group scored unpleasant taste as 0.6 (0.74), while the high-volume group gave unpleasant taste a score of 2.2 (0.97) and the medium-volume group gave a score of 2.1 (1.36), P < 0.01. Conclusion: In this pilot study, the low-volume colon preparation Prepopik® may be preferred in the inpatient setting due its better rate of tolerability and comparable bowel cleanliness when compared to larger volume preparation, although we cannot overreach any definitive conclusion. Further more robust studies are required to confirm these findings.