Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination

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

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2015-06-30

Brief Summary

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There remains debate regarding whether small bowel cleansing is required prior to video capsule endoscopy, and if so, which method is best. This study prospectively tests cleansing with no preparation, preparation with picosalax, and preparation with polyethylene glycol.

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Detailed Description

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Conditions

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Endoscopy

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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1

Clear fluids only after lunch.

Group Type ACTIVE_COMPARATOR

Clear fluids

Intervention Type DRUG

Clear fluids only after lunch.

2

Two sachets of picosalax the evening prior to Video Capsule Endoscopy (VCE).

Group Type ACTIVE_COMPARATOR

Picosalax

Intervention Type DRUG

Two sachets the evening prior to Video Capsule Endoscopy (VCE).

3

Polyethylene glycol, 2 liters the evening prior to Video Capsule Endoscopy (VCE).

Group Type ACTIVE_COMPARATOR

Polyethylene glycol

Intervention Type DRUG

Two (2) litres the evening prior to Video Capsule Endoscopy (VCE).

Interventions

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Clear fluids

Clear fluids only after lunch.

Intervention Type DRUG

Picosalax

Two sachets the evening prior to Video Capsule Endoscopy (VCE).

Intervention Type DRUG

Polyethylene glycol

Two (2) litres the evening prior to Video Capsule Endoscopy (VCE).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients undergoing VCE.

Exclusion Criteria

* bowel obstruction or ileus;
* known stricture or fistula;
* previous small bowel surgery;
* severe gastroparesis or motility disorder
* renal impairment (serum creatinine over normal range within three months of study);
* congestive heart failure;
* cirrhosis;
* implanted cardiac pacemaker or defibrillator or other electromedical device;
* pregnancy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No