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Predictors of Poor Bowel Cleansing and Capsule Endoscopy (CEPREDICT) (CEPREDICT)
| Condition or disease | Intervention/treatment |
|---|---|
| Colon Adenoma | Device: Colon Capsule Endoscopy |
As in conventional colonoscopy, colon cleansing is essential to achieve a quality examination through the colon capsule endoscopy. The CCE also presents additional difficulties due to the inability to distend the walls of the colon, aspirate liquid and debris and wash. These reasons make that the colonic preparation should be even more effective when the exploration is going to be performed by CCE than with the conventional colonoscopy. Using a combination of PEG, sodium phosphate and bysacodil suppository achieves at least 80% of well-prepared CCE. The rate of CCE with inadequate preparation according to different studies ranges from 12% to 34% . It has recently been suggested that the addition of a water-soluble contrast agent such as Gastrografin® commonly used in different radiological tests could improve cleaning.
Although, predictive factors of poor bowel cleansing in outpatient conventional colonoscopy are well-known, currently, there are no studies that evaluate the independent predictive factors of poor colonic preparation in patients who undergo a CCE. The investigation of the predictive factors of poor colonic preparation in these patients, following the current recommendations can be of great interest to identify those patients with greater difficulties in obtaining an acceptable cleaning quality.
The researchers will offer to participate in the study to patients scheduled for CCE who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information on the diet and the bowel cleansing solution to be taken. The bowel cleansing quality following Spada Bowel Preparation Scale will be assessed by the endoscopist The aim of this study is to figure out the risk factors of bowel cleansing of inadequate bowel preparation in patients referred for colon capsule endoscopy.
A maximum of 8 variables in the multivariate analysis will be included. Considering a percentage of poor preparation of 20%, the inclusion of 350 patients will be necessary. A maximum of 15% of losses will be considered, so the final sample size will be 403 patients.
A univariate and multivariate analysis will be carried out to determine those factors associated with a lack of progression from capsule to rectum and accelerated progression. For the first of these objectives, well prepared colonoscopies but in which the rectum was not identified (identification of the hemorrhoidal plexus) will be excluded.
| Study Type : | Observational |
| Estimated Enrollment : | 403 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Risk Factors of Inadequate Bowel Cleansing in Colon Capsule Endoscopy |
| Estimated Study Start Date : | May 2019 |
| Estimated Primary Completion Date : | November 2020 |
| Estimated Study Completion Date : | December 2020 |
- Colon cleansing [ Time Frame: [Time frame: 20 months][Designated as safety issue: No] ]Quality of bowel cleansing assessed by the Spada Bowel Preparation Scale. Cleansing is classified from 1 ( no preparation) to 4 (excellent preparation) in each of the 4 segments of the colon (proximal colon, transverse colon, distal colon and rectum)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 28, 2019 | ||||
| First Posted Date | May 1, 2019 | ||||
| Last Update Posted Date | May 7, 2019 | ||||
| Estimated Study Start Date | May 2019 | ||||
| Estimated Primary Completion Date | November 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Colon cleansing [ Time Frame: [Time frame: 20 months][Designated as safety issue: No] ] Quality of bowel cleansing assessed by the Spada Bowel Preparation Scale. Cleansing is classified from 1 ( no preparation) to 4 (excellent preparation) in each of the 4 segments of the colon (proximal colon, transverse colon, distal colon and rectum)
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Predictors of Poor Bowel Cleansing and Capsule Endoscopy (CEPREDICT) | ||||
| Official Title | Risk Factors of Inadequate Bowel Cleansing in Colon Capsule Endoscopy | ||||
| Brief Summary | The main purpose of the study is to determine risk factors of poor bowel cleansing in patients referred for colon capsule endoscopy (CCE) examination. Patients will be prepared with polyethylene glycol (PEG), and a booster by using oral low volume sodium phosphate (NaP) and sodium-amidotrizoate and meglumine-amidotrizoate (Gastrografin ®) The investigators also will try to design a predictive score of poor bowel cleansing and to validate the Bowel cleansing score designed by Leighton and modified by Spada | ||||
| Detailed Description |
As in conventional colonoscopy, colon cleansing is essential to achieve a quality examination through the colon capsule endoscopy. The CCE also presents additional difficulties due to the inability to distend the walls of the colon, aspirate liquid and debris and wash. These reasons make that the colonic preparation should be even more effective when the exploration is going to be performed by CCE than with the conventional colonoscopy. Using a combination of PEG, sodium phosphate and bysacodil suppository achieves at least 80% of well-prepared CCE. The rate of CCE with inadequate preparation according to different studies ranges from 12% to 34% . It has recently been suggested that the addition of a water-soluble contrast agent such as Gastrografin® commonly used in different radiological tests could improve cleaning. Although, predictive factors of poor bowel cleansing in outpatient conventional colonoscopy are well-known, currently, there are no studies that evaluate the independent predictive factors of poor colonic preparation in patients who undergo a CCE. The investigation of the predictive factors of poor colonic preparation in these patients, following the current recommendations can be of great interest to identify those patients with greater difficulties in obtaining an acceptable cleaning quality. The researchers will offer to participate in the study to patients scheduled for CCE who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information on the diet and the bowel cleansing solution to be taken. The bowel cleansing quality following Spada Bowel Preparation Scale will be assessed by the endoscopist The aim of this study is to figure out the risk factors of bowel cleansing of inadequate bowel preparation in patients referred for colon capsule endoscopy. A maximum of 8 variables in the multivariate analysis will be included. Considering a percentage of poor preparation of 20%, the inclusion of 350 patients will be necessary. A maximum of 15% of losses will be considered, so the final sample size will be 403 patients. A univariate and multivariate analysis will be carried out to determine those factors associated with a lack of progression from capsule to rectum and accelerated progression. For the first of these objectives, well prepared colonoscopies but in which the rectum was not identified (identification of the hemorrhoidal plexus) will be excluded. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | All patients referred for colon capsule endoscopy meeting inclusion and exclusion criteria will be included in the study. Spanish hospitals with the availability of colon capsule endoscopy will be invited to participate in the study | ||||
| Condition | Colon Adenoma | ||||
| Intervention | Device: Colon Capsule Endoscopy
The capsule endoscopy will be ingested by the participant. This device captures images along the large bowel. This images are stored in an external memory and afterwards they are downloaded in a computer
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
403 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 2020 | ||||
| Estimated Primary Completion Date | November 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03933371 | ||||
| Other Study ID Numbers | CEPREDICT | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Hospital Universitario de Canarias | ||||
| Study Sponsor | Hospital Universitario de Canarias | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Hospital Universitario de Canarias | ||||
| Verification Date | May 2019 | ||||
