A New Method for Bowel Cleansing in Patients With a History of Poor Bowel Preparation - A Multicenter Feasibility Study With the Pure-Vu System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Boston Bowel Preparation scale (BBPS)-score before cleaning with the Pure-Vu system.
研究概览
简要总结
The diagnostic accuracy and safety of colonoscopy highly depends on the quality of the pre-procedural bowel preparation. A past history of poor bowel preparation is the most important risk factor of inadequate bowel cleansing at the next colonoscopy. This study aims to evaluate if an adequate level of bowel cleansing can be achieved with the Pure-Vu System in patients with previous poor bowel preparation, in a single arm international multicenter feasibility study.
详细描述
Rationale: It is widely acknowledged that the efficacy and safety of colonoscopy depends on the quality of the pre-procedural bowel preparation. Despite its importance, the proportion of colonoscopies with inadequate bowel preparation still ranges from 6.8-33% across studies. A past history of poor bowel preparation is the most important risk factor of inadequate bowel cleansing at the next colonoscopy. (1, 2) Evidence to recommend a specific bowel cleansing regimen in these patients is currently lacking. (3) Mostly, patients with previous bowel preparation are advised to drink more oral purgatives, which is very difficult and unpleasant for patients and therefore often fails.
The aim of this study is to evaluate if an intra-procedural bowel cleaning device, the Pure-VuTM System (Tirat Carmel, Israel) can be used to achieve an adequate level of bowel cleansing in patients with previous poor bowel preparation.
Objective: The aim of this study is to evaluate if an adequate level of bowel cleansing can be achieved with the Pure-Vu System in patients with previous poor bowel preparation (Boston Bowel Preparation Scale [BBPS]<6).
Study design: We will perform a single arm international multicenter colonoscopy trial. Adult patients with previous poor bowel preparation (BBPS<6) will be invited to participate in our study (n= 44). All patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System. The BBPS will be assessed before and after segmental washing by the endoscopist who performs the procedure and later by an independent endoscopist (photos).
Study population: Adult patients with poor bowel preparation within the last 2 years. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
Independent assessment of BBPS (photos).
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, aged between 18 and 80 years, referred and scheduled for either screening, diagnostic, or surveillance colonoscopy.
- •Poor bowel preparation within the last 2 years, defined as a BBPS <6 or need for repeat colonoscopy or shortening of surveillance interval due to poor bowel preparation
排除标准
- •Prior colon resection
- •Previous colorectal cancer
- •Lower gastrointestinal bleeding with hemodynamic instability
- •Bowel obstruction
- •Pregnancy or lactating
- •Insufficiently corrected anticoagulation disorders
- •Inability to provide informed consent
结局指标
主要结局
Boston Bowel Preparation scale (BBPS)-score before cleaning with the Pure-Vu system.
时间窗: 1 day (day of intervention)
Boston Bowel Preparation scale (BBPS): The adequacy of bowel preparation should be assessed after all appropriate efforts to clear residual debris is completed. All three bowel regions of the colon will be scored (i.e., the right colon, transverse colon, and left colon) from 0-3 points by the endoscopist. The segment scores are summed for a total BBPS ranging from 0 to 9. The points will be assigned as follows: 0) Unprepared colon segment with mucosa not seen because of solid stool that could not be cleared. 1. Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid. 2. Minor amount of residual staining, small fragments of stool, and/or opaque liquid but mucosa of colon segment seen well. 3. Entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. Each segment of the colon received a segmental score from 0- 3.
Boston Bowel Preparation scale (BBPS)-score after cleaning with the Pure-Vu system.
时间窗: 1 day (day of intervention)
Boston Bowel Preparation scale (BBPS): The adequacy of bowel preparation should be assessed after all appropriate efforts to clear residual debris is completed. All three bowel regions of the colon will be scored (i.e., the right colon, transverse colon, and left colon) from 0-3 points by the endoscopist. The segment scores are summed for a total BBPS ranging from 0 to 9. The points will be assigned as follows: 0) Unprepared colon segment with mucosa not seen because of solid stool that could not be cleared. 1. Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid. 2. Minor amount of residual staining, small fragments of stool, and/or opaque liquid but mucosa of colon segment seen well. 3. Entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. Each segment of the colon received a segmental score from 0- 3.
次要结局
- Adenoma detection rate(1 day (day of intervention))
- Cecal intubation rates(1 day (day of intervention))
- Total number of colon lesions specified by histology(1 day (day of intervention))
- Total amount of water used for washing and total amount of fluids+residual stool removed.(1 day (day of intervention))
- Endoscopists' learning curve(through study completion, an average of 1 year)
- Procedure times (total procedure time, cecal intubation time, withdrawal time, time for all other interventions)(1 day (day of intervention))
- Patient reported outcomes (level of discomfort during bowel preparation and during colonoscopy on a visual analog scale)(1 month)
- System usability(through study completion, an average of 1 year)
- Number of adverse events after study intervention(48 hours and 1month after intervention)