Colonoscopy Preparation Optimization for INpatients- COIN Study

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

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-12-31

Brief Summary

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Colonoscopic examinations are performed routinely in hospitalized patients for a variety of indications. However, numerous limitations exist in hospitalized patients preventing an endoscopist from performing high quality examinations; possibly necessitating repeated procedures leading to increased cost and re-exposure to their inherent risks. One such prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown to be a predictor of poor bowel preparation as these patients are older, less mobile and have more co morbidities than the outpatient population. Currently, no standardized (or optimized) bowel preparation type or regimen for administration exists for the hospital inpatient population undergoing colonoscopy. Studies in the outpatient population have demonstrated that timing and choice of cathartic medication effects the cleanliness of the bowel preparation but there is no such clinical evidence for in-patients who receive whatever cathartic agent is on hospital formulary. The purpose of the study is compare efficacy, patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax) to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of dosages.

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Detailed Description

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Conditions

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Endoscopy Bowel Preparation Solutions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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PEG Lyte

PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy.

Group Type ACTIVE_COMPARATOR

Bisacodyl 10mg

Intervention Type DRUG

Given at the start of the bowel preparation the day before colonoscopy

Polyethelene Glycol

Intervention Type DRUG

280g reconstituted in 4 liters of water

Pico Salax Split

Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy.

Group Type EXPERIMENTAL

Bisacodyl 10mg

Intervention Type DRUG

Given at the start of the bowel preparation the day before colonoscopy

Picosulfate sodium

Intervention Type DRUG

Two sachets, Each sachet has 10mg dose

Pico Salax Night Before

2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy

Group Type EXPERIMENTAL

Bisacodyl 10mg

Intervention Type DRUG

Given at the start of the bowel preparation the day before colonoscopy

Picosulfate sodium

Intervention Type DRUG

Two sachets, Each sachet has 10mg dose

Interventions

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Bisacodyl 10mg

Given at the start of the bowel preparation the day before colonoscopy

Intervention Type DRUG

Polyethelene Glycol

280g reconstituted in 4 liters of water

Intervention Type DRUG

Picosulfate sodium

Two sachets, Each sachet has 10mg dose

Intervention Type DRUG

Other Intervention Names

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PEG-Lyte Pico-Salax

Eligibility Criteria

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Inclusion Criteria

* Inpatient colonoscopy
* Age greater than 18 years old
* Able to give consent

Exclusion Criteria

* No consent obtained
* Pregnancy or lactating
* Renal impairment
* Severe CHF (NYHA class 3/4)
* Recent myocardial infarction (preceding 6 months)
* Ileus
* Ascites
* Severe Colitis
* Toxic Megacolon
* Gastrointestinal Obstruction
* PEG tube
* Previous large bowel resection
* Allergy to study drug

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No