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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-05-31

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).

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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.

Conditions

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Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Single-dose Polyethylene Glycol regimen

Drug: Polyethylene Glycol Intervention: 2 liters of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion.

Group Type ACTIVE_COMPARATOR

Capsule endoscopy

Intervention Type DEVICE

Endoscopic device

Polyethylene Glycol

Intervention Type DRUG

Bowel purgative

Split-dose Polyethylene Glycol regimen

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.

Group Type EXPERIMENTAL

Capsule endoscopy

Intervention Type DEVICE

Endoscopic device

Polyethylene Glycol

Intervention Type DRUG

Bowel purgative

Interventions

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Capsule endoscopy

Endoscopic device

Intervention Type DEVICE

Polyethylene Glycol

Bowel purgative

Intervention Type DRUG

Other Intervention Names

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PEG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes