The Best Dosage and Timing of Polyethylene Glycol for Bowel Preparation Before Capsule Endoscopy

Study Overview
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Brief Summary
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The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in patients referred for CE examination.

Official Title
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The Best Dosage and Timing of PEG for Bowel Preparation Before Capsule Endoscopy a Prospective, Single-Blind, Randomized, Multi-center Study

Conditions
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Small Bowel Disease

Intervention / Treatment
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* Drug: polyethylene glycol
* Device: capsule endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 and 75 years and referred to capsule endoscopy because of suspected small-bowel disease are prospectively eligible for entry into the study. Exclusion Criteria: Age < 18 or > 75 years Known or suspected GI stricture or fistula A history of GI tract resection Swallowing disorders Intensive therapy with fasting and parenteral nutrition;with a disease that may reduce movement of the GI tract, such as diabetes mellitus Medications that could affect gastrointestinal movement within one week Implanted with a medical electronic device Active inflammatory bowel disease, toxic megacolon, toxic colitis Severe pulmonary, cardiac, renal, or hepatic disease Uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg); Disturbance of electrolytes Pregnancy or lactation Patients inability to provide written voluntary informed consent Participation in another clinical study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Fast for 12h before the examination and take 8ml of Simethicone Emulsion (Berlin-Chemie, Germany, containing 40 mg simethicone in 1mL emulsion) with 250ml water 30min before capsule ingestion.CE are performed with the Pillcam SB2 capsule endoscopy system (Given Imaging Co. Ltd., Yoqnem, Israel). | Device: capsule endoscopy<br> <br> |
| Active Comparator: Group B<br>the same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. | Drug: polyethylene glycol<br> <br> Device: capsule endoscopy<br> <br> |
| Active Comparator: Group C<br>the same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. | Drug: polyethylene glycol<br> <br> Device: capsule endoscopy<br> <br> |
| Active Comparator: Group D<br>Group D: the same as protocol A plus 1L Polyethylene glycol 3-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. | Drug: polyethylene glycol<br> <br> Device: capsule endoscopy<br> <br> |
| Active Comparator: Group E<br>Group E: the same as protocol A plus 2L Polyethylene glycol 2-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. | Drug: polyethylene glycol<br> <br> Device: capsule endoscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the quality of visualization of the small bowel | The image quality was evaluated only in cases in which the capsule reached the cecum within the examination period. All CE images will be assessed at low speed (10 frames/s) under the AutoView mode of the RAPID workstation (Given Imaging). The intestinal mucosa is defined as clean if, less than 25% of the mucosal surface was covered by dark liquid, bubbles or debris. Using a timer, the investigators record the exact time period during which the small intestinal mucosa was clean. The definition of excellent is at least 90% of the overall small bowel mucosa is clean (the sum of clean time /total small bowel transit time>90%). And the definition of good is at least 80% of the overall small bowel mucosa is clean. We considered that excellent or good preparation is adequate to make an accurate diagnosis. | one week after CE procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient acceptability | A visual analogical scale (VAS) is used to evaluate the degree of patients' discomfort. The numerical scale between 0 and 10, with 0 being no burden at all and 10 indicating an intolerable procedure. The questionnaire provide information about whether they experienced nausea, bloating, or any discomfort during the bowel preparation, difficulty to complete the preparation, their willingness to repeat the same preparation in the future (yes or no)and did it affect their daily activity and nocturnal rest. | day of CE procedure | 
| diagnostic rate |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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capsule endoscopy, polyethylene glycol, bowel preparation solutions