ColonoscopyNCT01978509
The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies
A study testing Low volume prep (Prepopik), Moderate volume prep (Moviprep) and High volume prep (Golytely) in people with Colonoscopy, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Low volume prep (Prepopik), Moderate volume prep (Moviprep) and High volume prep (Golytely)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inpatient colonoscopy
- Age 18 years and older
- Able to give consent
- Split dose colonoscopies for all patients
Who cannot join
- Unable to give consent
- Pregnant or lactating women
- Renal impairment (GFR <30)
- Ileus
- Ascites
- Toxic megacolon
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Colonoscopy
- Being tested
- Low volume prep (Prepopik), Moderate volume prep (Moviprep), High volume prep (Golytely)
- Keywords
- Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low volume prep (Prepopik)Drug
Also called 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)Drug
Also called 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)Drug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Low volume prep (Prepopik) | Active comparator | Low volume prep for colonoscopy (Prepopik) Receives: Drug: Low volume prep (Prepopik) |
| Moderate volume prep (Moviprep) | Active comparator | Moderate volume prep for colonoscopy (Moviprep) Receives: Drug: Moderate volume prep (Moviprep) |
| High volume prep (Golytely) | Active comparator | High volume prep for colonoscopy (Golytely) Receives: Drug: High volume prep (Golytely) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2019
- Study completionMar 2019
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco C. Ramirez, M.D., Mayo Clinic
- Investigators
- Francisco Ramirez, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978509
- Sponsor's protocol ID
- 13-003983
- Status last verified
- Jul 2020
- First submitted
- 23 Sep 2013
- Last updated
- 17 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32660521
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies
- ClinicalTrials.gov ID
- NCT01978509
- Acronym / sponsor ID
- 13-003983
- Conditions
- Colonoscopy
- Keywords
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Posted 17 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low volume prep (Prepopik) | Active comparator | Drug: Low volume prep (Prepopik)Low volume prep for colonoscopy (Prepopik) |
| Moderate volume prep (Moviprep) | Active comparator | Drug: Moderate volume prep (Moviprep)Moderate volume prep for colonoscopy (Moviprep) |
| High volume prep (Golytely) | Active comparator | Drug: High volume prep (Golytely)High volume prep for colonoscopy (Golytely) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inpatient colonoscopy
- Age 18 years and older
- Able to give consent
- Split dose colonoscopies for all patients
Key exclusion criteria (13 listed)
- Unable to give consent
- Pregnant or lactating women
- Renal impairment (GFR <30)
- Ileus
- Ascites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low volume prep (Prepopik)Also: PrepopikHospitalized 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. | Drug | Low volume prep (Prepopik) |
| Moderate volume prep (Moviprep)Also: MoviprepHospitalized 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. | Drug | Moderate volume prep (Moviprep) |
| High volume prep (Golytely)Also: GolytelyHospitalized 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. | Drug | High volume prep (Golytely) |
Primary outcome
Bowel Cleansing
Time frame: 24 hours
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.
1 secondary outcome
Cancellation or Delay of Procedure Due to Poor Bowel Preparation
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32660521Hernandez 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Ramirez, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low volume prep (Prepopik), Moderate volume prep (Moviprep) and High volume prep (Golytely) in people with Colonoscopy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Cleansing (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01978509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.