The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies

NCT ID: NCT01978509

Last Updated: 2020-07-17

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2019-03-31

Brief Summary

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The purpose of this study is to compare the efficacy of a low-volume bowel preparation versus a high-volume bowel preparation for bowel cleansing on hospitalized patients undergoing colonoscopies.

Detailed Description

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Conditions

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Colonoscopy

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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Low volume prep (Prepopik)

Low volume prep for colonoscopy (Prepopik)

Group Type ACTIVE_COMPARATOR

Low volume prep (Prepopik)

Intervention Type DRUG

Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.

Moderate volume prep (Moviprep)

Moderate volume prep for colonoscopy (Moviprep)

Group Type ACTIVE_COMPARATOR

Moderate volume prep (Moviprep)

Intervention Type DRUG

Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.

High volume prep (Golytely)

High volume prep for colonoscopy (Golytely)

Group Type ACTIVE_COMPARATOR

High volume prep (Golytely)

Intervention Type DRUG

Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.

Interventions

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Low volume prep (Prepopik)

Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.

Intervention Type DRUG

Moderate volume prep (Moviprep)

Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.

Intervention Type DRUG

High volume prep (Golytely)

Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.

Intervention Type DRUG

Other Intervention Names

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Prepopik Moviprep Golytely

Eligibility Criteria

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Inclusion Criteria

1. Inpatient colonoscopy
2. Age 18 years and older
3. Able to give consent
4. Split dose colonoscopies for all patients

Exclusion Criteria

1. Unable to give consent
2. Pregnant or lactating women
3. Renal impairment (GFR \<30)
4. Ileus
5. Ascites
6. Toxic megacolon
7. Gastrointestinal obstruction
8. Allergy to study drugs
9. Toxic colitis
10. Not able to split the dose of bowel preparations to be used
11. Contraindication to bowel preparation
12. Risk for aspiration
13. Risk of severe cardiac arrhythmias
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Francisco C. Ramirez, M.D.

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco Ramirez, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

References

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Hernandez PV, Horsley-Silva JL, Snyder DL, Baffy N, Atia M, Koepke L, Buras MR, Lim ES, Ruff K, Umar SB, Islam S, Ramirez FC. Effect of bowel preparation volume in inpatient colonoscopy. Results of a prospective, randomized, comparative pilot study. BMC Gastroenterol. 2020 Jul 13;20(1):227. doi: 10.1186/s12876-020-01373-1.

Reference Type DERIVED
PMID: 32660521 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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13-003983

Identifier Type: -

Identifier Source: org_study_id

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