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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-06-30

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.

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Detailed Description

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Conditions

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Small Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

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).

Group Type ACTIVE_COMPARATOR

capsule endoscopy

Intervention Type DEVICE

Group B

the same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.

Group Type ACTIVE_COMPARATOR

polyethylene glycol

Intervention Type DRUG

capsule endoscopy

Intervention Type DEVICE

Group C

the same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.

Group Type ACTIVE_COMPARATOR

polyethylene glycol

Intervention Type DRUG

capsule endoscopy

Intervention Type DEVICE

Group D

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.

Group Type ACTIVE_COMPARATOR

polyethylene glycol

Intervention Type DRUG

capsule endoscopy

Intervention Type DEVICE

Group E

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.

Group Type ACTIVE_COMPARATOR

polyethylene glycol

Intervention Type DRUG

capsule endoscopy

Intervention Type DEVICE

Interventions

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polyethylene glycol

Intervention Type DRUG

capsule endoscopy

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No