Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy

Study Overview
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Brief Summary
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To compare the small bowel cleanliness for wireless capsule endoscopy using two different Polyethylene Glycol administration schedules (before the wireless capsule endoscopy ingestion versus in a split-dose fashion).

Detailed Description
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The image quality obtained from the wireless capsule endoscopy improves its diagnostic yield. The amount of visualized mucosa is in direct correlation with the diagnostic yield. Nonetheless, frequently, the quality of the image obtained is hampered by the presence of bubbles, debris, bile and enteric fluid. Therefore many efforts have been putted in order to eliminate this factor such as the use of prokinetics, simethicone and bowel purgatives. The latter (namely the polyethylene glycol - PEG - solution) has accumulated evidence and is, therefore, recommended by the last European guidelines. Usually, the cleansing starts and finish in the day before the capsule endoscopy ingestion. We hypothesized that, similarly to what had become evidence to large bowel cleansing, a shorter gap between the polyethylene glycol intake and the exam could provide a better capsule endoscopy image quality and therefore gauging our diagnostic yield.

Official Title
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Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy Is Timing of Preparation for Capsule Endoscopy the Key for the Best Small-bowel Cleansing?

Conditions
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Bowel Preparation

Intervention / Treatment
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* Device: Capsule endoscopy
* Drug: Polyethylene Glycol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients referred to our institution for CE during the study period Exclusion Criteria: inpatients, bedridden, patients with clinical evidence of active bleeding, past history of abdominal surgery, abdominal or pelvic radiation therapy, occlusion, bowel perforation (suspected or confirmed), use of oral iron replacement therapy, severe cardiopulmonary, renal or hepatic disease, pregnancy, hypersensitivity to any components of the preparation, patients that didn't complete the preparation protocol, patients with incomplete enteroscopies (a complete enteroscopy is defined by the visualization of the mucosa from the duodenal bulb to the cecum), patients enrolled in other clinical studies and patients who didn't signed informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single-dose Polyethylene Glycol regimen<br>Drug: Polyethylene Glycol Intervention: 2 liters of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion. | Device: Capsule endoscopy<br>* Endoscopic device<br>Drug: Polyethylene Glycol<br>* Bowel purgative<br>* Other names: PEG;|
| Experimental: Split-dose Polyethylene Glycol regimen<br>Drug: Polyethylene Glycol Intervention: 1 liter of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion and another 1 liter Polyethylene Glycol will be given in the same day of Capsule Endoscopy ingestion. | Device: Capsule endoscopy<br>* Endoscopic device<br>Drug: Polyethylene Glycol<br>* Bowel purgative<br>* Other names: PEG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small-bowel cleanliness | The cleansing quality of the small-bowel will be evaluated according to the system validated by Brotz et al., using the quantitative index (QI), because this score is less susceptible to the subjective element. The used cut-off value accepted for an adequate small-bowel cleansing was ≥ 8 points. | at the end of capsule endoscopy exploration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of all the observed lesions | Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential. | at the end of capsule endoscopy exploration | 
| The clinical tolerance questionnaire | Evaluate the clinical tolerance and the acceptability of the bowel preparation with the oral polyethylene glycol solution. | at the end of capsule endoscopy exploration | 
| The transit time | Compare gastric transit time and the small bowel transit time. | at the end of capsule endoscopy exploration |