Bowel PreparationNCT04970173
1L-PEG-Asc Solution for Bowel Preparation in an "Open Access" Colonoscopy Booking System: Evaluation of Adverse Events
An observational study of Bowel Preparation, run by Azienda USL Modena at 1 site in Italy.
Trial summary
Several factors are considered as the key indicators of quality colonoscopy, including endoscopist experience, withdrawal time, and quality of bowel preparation (BP). A number of laxatives are currently used as BP, and these are mainly based on PEG agents that differ for the volume and the addition of adjuvants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- use of a very low-volume 1L-PEG plus ascorbate (plenvu) or low-volume 2L-PEG plus ascorbate (moviprep) for bowel preparation in open access colonoscopy
- How many people
- 5,981 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Only consecutive patients taking Plenvu (1L-PEG-Asc, Norgine, Harefield, UK) or Moviprep (2L-PEG-Asc, Norgine, Harefield, UK) were considered in our analyses, from January 2019 to September 2020
Who may be able to join
- From January 2019 to September 2020, data from all consecutive adult (aged ≥ 18 years old) patients who underwent "open access" colonoscopy performed in our Digestive Endoscopy Unit (which is based in the Hospitals of Carpi, Castelfranco Emilia, Mirandola, Pavullo and Vignola) were collected using an electronic reporting system
Who cannot join
- Pregnant of breastfeeding patients
Trial locations and contacts
1 site in 1 country.
About this study
Several factors are considered as the key indicators of quality colonoscopy, including endoscopist experience, withdrawal time, and quality of bowel preparation (BP). A number of laxatives are currently used as BP, and these are mainly based on PEG agents that differ for the volume and the addition of adjuvants. Several trials have demonstrated the efficacy and safety of low volume 2L-PEG based regimens compared with high volume PEG regimens and non-PEG agents. However, for low-volume 1L-PEG plus ascorbate (1L-PEG-Asc) only the data from registration trials are available, and none of these have been performed in an "open access" colonoscopy booking system. The aim of our study was to evaluate the safety and tolerability of 1L-PEG-Asc compared to 2L-PEG plus ascorbate (2L-PEG-Asc) in an "open access" booking system.
Read the detailed description
All patients who underwent "open access" colonoscopy in our Unit from January 2019 to September 2020 were evaluated as part of a quality improvement project. Only patients taking 2L-PEG-Asc and 1L-PEG-Asc were enrolled in this study. Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy. Tolerability was evaluated as the compliance to full BP intake
- Conditions
- Bowel Preparation
- Being tested
- use of a very low-volume 1L-PEG plus ascorbate (plenvu) or low-volume 2L-PEG plus ascorbate (moviprep) for bowel preparation in open access colonoscopy
- Keywords
- safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of a very low-volume 1L-PEG plus ascorbate (plenvu) or low-volume 2L-PEG plus ascorbate (moviprep) for bowel preparation in open access colonoscopyOther
Patients are free to choice the kind of BP in an open access booking system colonoscopy. The safety of BPs was assessed by reviewing the clinical and laboratory data of patients who attended the Emergency Department (ED) of the five Hospitals of our Digestive Endoscopy Unit in the 7 days following the colonoscopy. This was feasible since the electronic reporting system is the same across our five Hospitals.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients taking very low-volume 1L-PEG plus ascorbate (plenvu) for open access colonoscopy Receives: Other: use of a very low-volume 1L-PEG plus ascorbate (plenvu) or low-volume 2L-PEG plus ascorbate (moviprep) for bowel preparation in open access colonoscopy | |
| 2 | patients taking low-volume 2L-PEG plus ascorbate (moviprep) for open access colonoscopy Receives: Other: use of a very low-volume 1L-PEG plus ascorbate (plenvu) or low-volume 2L-PEG plus ascorbate (moviprep) for bowel preparation in open access colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy.
The safety of BPs was assessed by reviewing the clinical and laboratory data of patients who attended the Emergency Department (ED) of the five Hospitals of our Digestive Endoscopy Unit in the 7 days following the colonoscopy. This was feasible since the electronic reporting system is the same across our five Hospitals.
Measured: from January 2019 to September 2020
Secondary outcomes (1)
Tolerability was evaluated as the compliance to full BP intake.
it was recorded for evert patient before the beginning of colonoscopy
Measured: from January 2019 to September 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Jan 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 5,981 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mauro Manno, Azienda USL Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970173
- Sponsor's protocol ID
- 01-2021
- Status last verified
- Jul 2021
- First submitted
- 11 Jul 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1L-PEG-Asc Solution for Bowel Preparation in an "Open Access" Colonoscopy Booking System: Evaluation of Adverse Events
- ClinicalTrials.gov ID
- NCT04970173
- Acronym / sponsor ID
- 01-2021
- Conditions
- Bowel Preparation
- Keywords
- safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,981 participants (actual)
- Lead sponsor
- Azienda USL ModenaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several factors are considered as the key indicators of quality colonoscopy, including endoscopist experience, withdrawal time, and quality of bowel preparation (BP). A number of laxatives are currently used as BP, and these are mainly based on PEG agents that differ for the volume and the addition of adjuvants. Several trials have demonstrated the efficacy and safety of low volume 2L-PEG based regimens compared with high volume PEG regimens and non-PEG agents. However, for low-volume 1L-PEG plus ascorbate (1L-PEG-Asc) only the data from registration trials are available, and none of these have been performed in an "open access" colonoscopy booking system. The aim of our study was to evaluate the safety and tolerability of 1L-PEG-Asc compared to 2L-PEG plus ascorbate (2L-PEG-Asc) in an "open access" booking system.
Detailed description
All patients who underwent "open access" colonoscopy in our Unit from January 2019 to September 2020 were evaluated as part of a quality improvement project. Only patients taking 2L-PEG-Asc and 1L-PEG-Asc were enrolled in this study. Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy. Tolerability was evaluated as the compliance to full BP intake
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: use of a very low-volume 1L-PEG plus ascorbate (plenvu) or low-volume 2L-PEG plus ascorbate (moviprep) for bowel preparation in open access colonoscopypatients taking very low-volume 1L-PEG plus ascorbate (plenvu) for open access colonoscopy |
| 2 | – | Other: use of a very low-volume 1L-PEG plus ascorbate (plenvu) or low-volume 2L-PEG plus ascorbate (moviprep) for bowel preparation in open access colonoscopypatients taking low-volume 2L-PEG plus ascorbate (moviprep) for open access colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Only consecutive patients taking Plenvu (1L-PEG-Asc, Norgine, Harefield, UK) or Moviprep (2L-PEG-Asc, Norgine, Harefield, UK) were considered in our analyses, from January 2019 to September 2020
Key inclusion criteria (1 listed)
- From January 2019 to September 2020, data from all consecutive adult (aged ≥ 18 years old) patients who underwent "open access" colonoscopy performed in our Digestive Endoscopy Unit (which is based in the Hospitals of Carpi, Castelfranco Emilia, Mirandola, Pavullo and Vignola) were collected using an electronic reporting system
Key exclusion criteria (1 listed)
- Pregnant of breastfeeding patients
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 |
|---|---|---|
| use of a very low-volume 1L-PEG plus ascorbate (plenvu) or low-volume 2L-PEG plus ascorbate (moviprep) for bowel preparation in open access colonoscopyPatients are free to choice the kind of BP in an open access booking system colonoscopy. The safety of BPs was assessed by reviewing the clinical and laboratory data of patients who attended the Emergency Department (ED) of the five Hospitals of our Digestive Endoscopy Unit in the 7 days following the colonoscopy. This was feasible since the electronic reporting system is the same across our five Hospitals. | Other | 1, 2 |
Primary outcome
Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy.
Time frame: from January 2019 to September 2020
The safety of BPs was assessed by reviewing the clinical and laboratory data of patients who attended the Emergency Department (ED) of the five Hospitals of our Digestive Endoscopy Unit in the 7 days following the colonoscopy. This was feasible since the electronic reporting system is the same across our five Hospitals.
1 secondary outcome
Tolerability was evaluated as the compliance to full BP intake.
Time frame: from January 2019 to September 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Preparation, run by Azienda USL Modena at 1 site in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Mar 2022. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy. (time frame: from January 2019 to September 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2022; AzTrials last refreshed its copy on 1 Nov 2026.