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NCT01978509 Clinical Trial

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

Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01978509
Other study ID # 13-003983
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date March 2019

Study information
Verified date July 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 32
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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.
• 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.
• 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.

Locations
Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Patient Tolerance Percentage of participants self-reporting finishing the bowel preparation 24 hours
Other Cecal Intubation Assess the success of cecal intubation rate between three bowel preparations. 24 hours
Primary 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 Cancellation or Delay of Procedure Due to Poor Bowel Preparation To assess the rate of delayed and or cancellation of procedure due to inadequate bowel preparation 24 hours
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Active, not recruiting NCT02264249 - Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation N/A
Completed NCT01964417 - The Comparative Study Between Bowel Preparation Method Phase 3
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Completed NCT00390598 - PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy Phase 2/Phase 3
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Completed NCT00427089 - Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening Phase 3
Completed NCT05823350 - The Effect of Abdominal Massage on Pain and Distention After Colonoscopy N/A
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