A new method for bowel cleansing in patients with a history of poor bowel preparation * A multicenter feasibility study with the Pure-Vu
Completed
- Conditions
- Colorectal neoplasms10017990
- Registration Number
- NL-OMON49503
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 22
Inclusion Criteria
18 years or older, referred for colonoscopy, previous
inadequate bowel preparation
Exclusion Criteria
Exclusion criteria; previous colon resection, previous colorectal cancer,
colitis, lower gastrointestinal bleeding with hemodynamic instability, ASA>3,
insufficiently corrected anticoagulation disorders, inability to provide
informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of the study will be the BBPS-score before and after<br /><br>intra-procedural bowel cleaning with the Pure-Vu. </p><br>
- Secondary Outcome Measures
Name Time Method <p>* Total number of colon lesions specified by histology<br /><br>* Adenoma detection rate<br /><br>* Cecal intubation rates<br /><br>* Procedure times (total procedure time, cecal intubation time, withdrawal<br /><br>time, time for washing, time for all other interventions)<br /><br>* Total amount of water used for washing and total amount of fluids+residual<br /><br>stool removed.<br /><br>* Patient reported outcomes (level of discomfort during bowel preparation and<br /><br>during colonoscopy on a visual analog scale)<br /><br>* System usability<br /><br>* Operator learning curve<br /><br>* Safety outcomes </p><br>