GastroIntestinal BleedingNCT05362227
High-Volume Vs Low-Volume Preparation in Emergency Department
A study testing Low volume macrogol and High volume macrogol in people with GastroIntestinal Bleeding, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The primary endpoint of this study was to compare the intestinal cleansing of patients with LGIB requiring colonoscopy, prepared with High-Volume or with Low-Volume who have to perform colonoscopy, directly from the ED. The intestinal cleansing was evaluated with the standardized Boston Bowel Preparation Scale (BBPS). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- GastroIntestinal Bleeding
- What is being tested?
- Low volume macrogol and High volume macrogol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2019to 30 Jun 2021
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males or females
- > 18 years and <85 years,
- hemodynamically stable,
- able to sign informed consent
- requiring colonoscopy
- anemia (loss of at least 2 g/dl of Hb) with or without active bleeding
Who cannot join
- suspected or confirmed pregnancy,
- hemodynamically unstable patients,
- patients unable to swallow or with known or suspected gastrointestinal obstruction or perforation,
- toxic megacolon,
- major colonic resection,
- heart failure (Class III or IV NYHA),
- severe liver failure,
- end-stage renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lower Gastrointestinal Bleeding in the Emergency Department: High-Volume Vs Low-Volume Peg Bowel Preparation for Colonoscopy
The primary endpoint of this study was to compare the intestinal cleansing of patients with LGIB requiring colonoscopy, prepared with High-Volume or with Low-Volume who have to perform colonoscopy, directly from the ED. The intestinal cleansing was evaluated with the standardized Boston Bowel Preparation Scale (BBPS).
The secondary endpoint was to evaluate the tolerability and compliance of patients prepared with High-Volume in comparison to Low-Volume in the ED.
- Conditions
- GastroIntestinal Bleeding
- Being tested
- Low volume macrogol, High volume macrogol
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low volume macrogolDrug
Clensia 2 lt
High volume macrogolDrug
Selg 4 lt
| Study group | Role | What they receive |
|---|---|---|
| High-Volume | Other | Patients in the group were instructed to take 4 L of solution on the day before the colonoscopy Receives: Drug: High volume macrogol |
| Low-Volume | Other | Patients in the group were instructed to take 2 L of solution on the day before the colonoscopy Receives: Drug: Low volume macrogol |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal cleansing
Using Boston Bowel Preparation Scale score (from 0 to 9, where 9 is worst preparation level)
Measured: during colonscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Nov 2019
- Primary completion30 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroIntestinal BleedingStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OJETTI VERONICA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Veronica Ojetti, Prof, Principal investigator, Fondazione Policlinico universitario a. Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362227
- Sponsor's protocol ID
- 20192668
- Status last verified
- Apr 2023
- First submitted
- 29 Apr 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saviano A, Petruzziello C, Riccioni ME, Di Pumpo M, Petrucci M, Brigida M, Zanza C, Candelli M, Franceschi F, Ojetti V. Lower Gastrointestinal Bleeding in the Emergency Department: High- Volume vs. Low-Volume Peg Bowel Preparation for Colonoscopy: A Randomized Trial. Rev Recent Clin Trials. 2023;18(1):76-81. doi: 10.2174/1574887117666220908152754.
PubMed 36089784
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Gastrointestinal Bleeding in the Emergency Department: High-Volume Vs Low-Volume Peg Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT05362227
- Acronym / sponsor ID
- 20192668
- Conditions
- GastroIntestinal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 May 2022 (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.
The primary endpoint of this study was to compare the intestinal cleansing of patients with LGIB requiring colonoscopy, prepared with High-Volume or with Low-Volume who have to perform colonoscopy, directly from the ED. The intestinal cleansing was evaluated with the standardized Boston Bowel Preparation Scale (BBPS).
The secondary endpoint was to evaluate the tolerability and compliance of patients prepared with High-Volume in comparison to Low-Volume in the ED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Volume | Other | Drug: High volume macrogolPatients in the group were instructed to take 4 L of solution on the day before the colonoscopy |
| Low-Volume | Other | Drug: Low volume macrogolPatients in the group were instructed to take 2 L of solution on the day before the colonoscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- males or females
- > 18 years and <85 years,
- hemodynamically stable,
- able to sign informed consent
- requiring colonoscopy
Key exclusion criteria (8 listed)
- suspected or confirmed pregnancy,
- hemodynamically unstable patients,
- patients unable to swallow or with known or suspected gastrointestinal obstruction or perforation,
- toxic megacolon,
- major colonic resection,
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 macrogolClensia 2 lt | Drug | Low-Volume |
| High volume macrogolSelg 4 lt | Drug | High-Volume |
Primary outcome
intestinal cleansing
Time frame: during colonscopy procedure
Using Boston Bowel Preparation Scale score (from 0 to 9, where 9 is worst preparation level)
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 4 Apr 2023.
- Derived from this study: PubMed 36089784Saviano A, Petruzziello C, Riccioni ME, Di Pumpo M, Petrucci M, Brigida M, Zanza C, Candelli M, Franceschi F, Ojetti V. Lower Gastrointestinal Bleeding in the Emergency Department: High- Volume vs. Low-Volume Peg Bowel Preparation for Colonoscopy: A Randomized Trial. Rev Recent Clin Trials. 2023;18(1):76-81. doi: 10.2174/1574887117666220908152754.
- 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.
Veronica Ojetti, Prof principal investigator
Fondazione Policlinico universitario a. Gemelli
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 macrogol and High volume macrogol in people with GastroIntestinal Bleeding, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 6 inclusion and 8 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 4 Apr 2023. 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?
intestinal cleansing (time frame: during colonscopy procedure). 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 NCT05362227, 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 4 Apr 2023.