NCT01978509

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 17, 2020

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

5.5 years

First QC Date

September 23, 2013

Results QC Date

July 6, 2020

Last Update Submit

July 6, 2020

Conditions

Colonoscopy

Keywords

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Bowel Cleansing

    Measured using the total Boston Bowel Prep Score (BBPS) obtained by adding scores from each segment for a range of minimum 0 = very poor and maximum 9 = excellent.

    24 hours

Secondary Outcomes (1)

  • Cancellation or Delay of Procedure Due to Poor Bowel Preparation

    24 hours

Other Outcomes (2)

  • Patient Tolerance

    24 hours

  • Cecal Intubation

    24 hours

Study Arms (3)

Low volume prep (Prepopik)

ACTIVE COMPARATOR

Low volume prep for colonoscopy (Prepopik)

Drug: Low volume prep (Prepopik)

Moderate volume prep (Moviprep)

ACTIVE COMPARATOR

Moderate volume prep for colonoscopy (Moviprep)

Drug: Moderate volume prep (Moviprep)

High volume prep (Golytely)

ACTIVE COMPARATOR

High volume prep for colonoscopy (Golytely)

Drug: High volume prep (Golytely)

Interventions

Low volume prep (Prepopik)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.

Also known as: Prepopik
Low volume prep (Prepopik)
Moderate volume prep (Moviprep)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.

Also known as: Moviprep
Moderate volume prep (Moviprep)
High volume prep (Golytely)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.

Also known as: Golytely
High volume prep (Golytely)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatient colonoscopy
  • Age 18 years and older
  • Able to give consent
  • Split dose colonoscopies for all patients

You may not qualify if:

  • Unable to give consent
  • Pregnant or lactating women
  • Renal impairment (GFR \<30)
  • Ileus
  • Ascites
  • Toxic megacolon
  • Gastrointestinal obstruction
  • Allergy to study drugs
  • Toxic colitis
  • Not able to split the dose of bowel preparations to be used
  • Contraindication to bowel preparation
  • Risk for aspiration
  • Risk of severe cardiac arrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Publications (1)

  • 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.

    PMID: 32660521DERIVED

Related Links

MeSH Terms

Interventions

MoviPrepGolytely

Results Point of Contact

Title
Dr. Francisco Ramirez
Organization
Mayo Clinic
Ramirez.Francisco@mayo.edu
(480) 301-6990

Study Officials

  • Francisco Ramirez, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 23, 2013

First Posted

November 7, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

July 17, 2020

Results First Posted

July 17, 2020

Record last verified: 2020-07

Locations

US(1)