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
Abstract 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 f...
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| Format: | Article |
| Language: | English |
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BMC
2021-05-01
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| Series: | BMC Gastroenterology |
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| Online Access: | https://doi.org/10.1186/s12876-021-01817-2 |
| _version_ | 1818597445137858560 |
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| author | Helmut Neumann Melissa Latorre Tim Zimmerman Gabriel Lang Jason Samarasena Seth Gross Bhaumik Brahmbhatt Haleh Pazwash Vladimir Kushnir |
| author_facet | Helmut Neumann Melissa Latorre Tim Zimmerman Gabriel Lang Jason Samarasena Seth Gross Bhaumik Brahmbhatt Haleh Pazwash Vladimir Kushnir |
| author_sort | Helmut Neumann |
| collection | DOAJ |
| description | Abstract 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). |
| first_indexed | 2024-12-16T11:47:55Z |
| format | Article |
| id | doaj.art-47dcb6017458414aa253c997d0dc5463 |
| institution | Directory Open Access Journal |
| issn | 1471-230X |
| language | English |
| last_indexed | 2024-12-16T11:47:55Z |
| publishDate | 2021-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Gastroenterology |
| spelling | doaj.art-47dcb6017458414aa253c997d0dc54632022-12-21T22:32:47ZengBMCBMC Gastroenterology1471-230X2021-05-012111810.1186/s12876-021-01817-2A multicenter, prospective, inpatient feasibility study to evaluate the use of an intra-colonoscopy cleansing device to optimize colon preparation in hospitalized patients: the REDUCE studyHelmut Neumann0Melissa Latorre1Tim Zimmerman2Gabriel Lang3Jason Samarasena4Seth Gross5Bhaumik Brahmbhatt6Haleh Pazwash7Vladimir Kushnir8Department of Gastroenterology and Hepatology, University Medical Center MainzDivision of Gastroenterology and Hepatology, New York University Langone Medical CenterDepartment of Gastroenterology and Hepatology, University Medical Center MainzDivision of Gastroenterology, Washington University in St. LouisDivision of Gastroenterology and Hepatology, Department of Medicine, University of California, IrvineDivision of Gastroenterology and Hepatology, New York University Langone Medical CenterDivision of Gastroenterology and Hepatology, Mayo ClinicDivision of Gastroenterology, Valley HospitalDivision of Gastroenterology, Washington University in St. LouisAbstract 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).https://doi.org/10.1186/s12876-021-01817-2Pure-Vu systemBowel preparationQuality improvementColonoscopy preparationColonoscopy |
| spellingShingle | Helmut Neumann Melissa Latorre Tim Zimmerman Gabriel Lang Jason Samarasena Seth Gross Bhaumik Brahmbhatt Haleh Pazwash Vladimir Kushnir 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 BMC Gastroenterology Pure-Vu system Bowel preparation Quality improvement Colonoscopy preparation Colonoscopy |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Pure-Vu system Bowel preparation Quality improvement Colonoscopy preparation Colonoscopy |
| url | https://doi.org/10.1186/s12876-021-01817-2 |
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