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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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A prospective, single center, study to evaluate the effectiveness of the HyGIeaCare Prep when used in combination with the PillCam COLON; the hypothesis is that the HyGIeaCare Prep will be easier for the patients to tolerate, and the results will be as good as the existing oral preparation.
Patients who agree to participate in the study will have their HyGIeaCare procedure and then will present to the PillCam COLON room, in the same suite for the PillCam COLON procedure.
The commercial preparations for the PillCam COLON procedure will be the same, except the HyGIeaCare procedure will replace the split polyethylene glycol-electrolyte solution preparation.
2-days prior:
Normal diet
10 glasses of liquid
1-day prior:
Clear liquid diet all day
Dulcolax 2 tabs at 2pm and 2 tabs at 8pm
Nothing by mouth after midnight
Day of Procedure:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HyGIeaCare and PillCam COLON | Experimental | Patient will receive the HyGIeaCare colon irrigation prior to their PillCam COLON procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HyGIeaCare colon irrigation | Device | PillCam COLON for visualization of bowel lining |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of colon irrigation | Effectiveness of the HyGIeaCare Prep will be measured using a 5-point scale to evaluate the visual quality of bowel cleanliness identified in the PillCam Colon video (Excellent, Good, Fair, Adequate, Poor). | Immediately after colon irrigation, PillCam COLON will be administered. A video will be taken of the procedure which will be used to measure the effectiveness of the colon irrigation. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of adverse events | The CTCAE tool will be used to evaluate outcomes | To be evaluated the day of the procedure |
| Evaluation of patient satisfaction | A standardized questionnaire will be used to measure outcomes |
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Inclusion Criteria:
Exclusion Criteria:
-
HyGIeaCare:
Patient has any condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study
Patient is treated long-term with narcotics.
Patient does not have any of the contraindications listed below:
PillCam COLON:
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| Name | Affiliation | Role |
|---|---|---|
| David A Johnson, MD | Eastern Virginia Medical Center | Principal Investigator |
| William Stassen, MD | Austin Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HyGIeaCare Center | Austin | Texas | 78757 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25803399 | Background | Sommers T, Corban C, Sengupta N, Jones M, Cheng V, Bollom A, Nurko S, Kelley J, Lembo A. Emergency department burden of constipation in the United States from 2006 to 2011. Am J Gastroenterol. 2015 Apr;110(4):572-9. doi: 10.1038/ajg.2015.64. Epub 2015 Mar 24. | |
| 17625982 | Result | Singh G, Lingala V, Wang H, Vadhavkar S, Kahler KH, Mithal A, Triadafilopoulos G. Use of health care resources and cost of care for adults with constipation. Clin Gastroenterol Hepatol. 2007 Sep;5(9):1053-8. doi: 10.1016/j.cgh.2007.04.019. Epub 2007 Jul 10. |
| Label | URL |
|---|---|
| Hydrotherapy compared with polyethylene glycol-electrolyte solution lavage and aqueous sodium phosphate as bowel preparation for elective colonoscopy: A prospective, randomized, single blinded trial | View source |
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Research outcomes will be evaluated by external statistician.
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HyGIeaCare colon irrigation procedure and PillCam COLON procedure
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| To be evaluated on the day of the procedure |
| Randomized trial comparing high volume rectal water irrigation with standard 4 liter split-dose polyethlene glycol-electrolyte solution preparation before colonoscopy | View source |
| HyGIeaCare® Preparation for Colonoscopy-A Technical Update for Success | View source |
| Multi-Dimensional Gastrointestinal Symptom Severity Index: Validation of a Brief GI Symptom Assessment Tool | View source |