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Lack of enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low volume prep (Prepopik) | Active Comparator | Low volume prep for colonoscopy (Prepopik) |
|
| Moderate volume prep (Moviprep) | Active Comparator | Moderate volume prep for colonoscopy (Moviprep) |
|
| High volume prep (Golytely) | Active Comparator | High volume prep for colonoscopy (Golytely) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Tolerance | Percentage of participants self-reporting finishing the bowel preparation | 24 hours |
| Cecal Intubation | Assess the success of cecal intubation rate between three bowel preparations. |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Ramirez, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32660521 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Volume Prep (Prepopik) | Low volume prep for colonoscopy (Prepopik) 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. |
| FG001 | Moderate Volume Prep (Moviprep) | Moderate volume prep for colonoscopy (Moviprep) 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. |
| FG002 | High Volume Prep (Golytely) | High volume prep for colonoscopy (Golytely) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Volume Prep (Prepopik) | Low volume prep for colonoscopy (Prepopik) 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
Adverse events were collected on all participants from study enrollment to study completion, approximately 24 hours. Adverse events were collected throughout the duration of the entire study, approximately 7 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Volume Prep (Prepopik) | Low volume prep for colonoscopy (Prepopik) 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francisco Ramirez | Mayo Clinic | (480) 301-6990 | Ramirez.Francisco@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2015 | Jun 22, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| C520497 | MoviPrep |
| C033608 | Golytely |
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|
|
| 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. |
|
|
| 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. |
|
|
| 24 hours |
| BG001 |
| Moderate Volume Prep (Moviprep) |
Moderate volume prep for colonoscopy (Moviprep) 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. |
| BG002 | High Volume Prep (Golytely) | High volume prep for colonoscopy (Golytely) 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | High Volume Prep (Golytely) | High volume prep for colonoscopy (Golytely) 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. |
|
|
|
| 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 | Study was terminated due to lack of enrollment and data not collected. | Posted | 24 hours |
|
|
| Other Pre-specified | Patient Tolerance | Percentage of participants self-reporting finishing the bowel preparation | Posted | Number | percentage of participants | 24 hours |
|
|
|
| Other Pre-specified | Cecal Intubation | Assess the success of cecal intubation rate between three bowel preparations. | Study was terminated due to lack of enrollment and data not collected. | Posted | 24 hours |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Moderate Volume Prep (Moviprep) | Moderate volume prep for colonoscopy (Moviprep) 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | High Volume Prep (Golytely) | High volume prep for colonoscopy (Golytely) 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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| Male |
|