ColonoscopyNCT04310332
1L- vs. 4L-PEG for Bowel Preparation Among Inpatients.
An observational study of Colonoscopy and Hospitalized Patients, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 10 sites in Italy.
Trial summary
Background and aims: Inpatients are at high risk for inadequate colon cleansing. Experts recommend 4L-polyethylene-glycol (PEG) solution because of its effectiveness and safety profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Hospitalized Patients, Bowel Preparation
- What is being tested?
- 1L-PEG and 4L-PEG
- How many people
- 1,004 participants
- Where
- 10 sitesItaly
- Study dates
- 1 Feb 2019to 15 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients who are scheduled a colonoscopy as inpatients.
Who may be able to join
- Adult inpatients scheduled for colonoscopy for any indication within the normal process of care.
Who cannot join
- patients who underwent emergency or elective therapeutic colonoscopies (e.g. polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection)
- patients who underwent bowel preparation outside the hospital
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Policlinico Sant'Orsola-Malpighi
Bologna
Digestive Endoscopy Unit, Fondazione Poliambulanza
Brescia
UOSD Gastroenterologia ed Endoscopia Digestiva, Azienda USL di Modena
Carpi
Gastroenterology Unit, Valduce Hospital
Como
Unit of Gastroenterology and Digestive Endoscopy, Forli-Cesena Hospital, AUSL Romagna
Forlì
Digestive Endoscopy Unit, Centro Traumatologico-Ortopedico Hospital
Iglesias
Department of Gastroenterology, ASST Rhodense, Rho and Garbagnate Milanese Hospital
Milan
Gastroenterology and Digestive Endoscopy Unit, Ospedale Maggiore della Carità
Novara
Department of Internal Medicine, Gastroenterology and Hepatology Unit, "Guglielmo da Saliceto" Hospital
Piacenza
Gastroenterology Unit, S. Maria delle Croci Hospital
Ravenna
About this study
Official title: 1L- vs. 4L-Polyethylene Glycol for Bowel Preparation Before Colonoscopy Among Inpatients: a Propensity Score-matching Analysis.
Background and aims: Inpatients are at high risk for inadequate colon cleansing. Experts recommend 4L-polyethylene-glycol (PEG) solution because of its effectiveness and safety profile. A higher colon cleansing adequacy rate for a hyperosmolar 1L-PEG plus ascorbate prep has been recently reported in an observational study among more than 1,000 inpatients. Thus, the present study is aimed at determining whether 1L-PEG outperforms 4L-PEG among inpatients, through a propensity score-matching between the two groups in order to correct for confounders.
- Conditions
- Colonoscopy, Hospitalized Patients, Bowel Preparation
- Being tested
- 1L-PEG, 4L-PEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1L-PEGDrug
The drug is 1L-PEG plus ascorbic acid (Plenvu®). It will be administered either the day before colonoscopy, or half the day before and half the day of colonoscopy, or the day of colonoscopy.
Patients are prescribed bowel prep according to local clinical practice and then all undergo colonoscopy. No standardized intervention on bowel prep is applied, as the design of the study is observational.
4L-PEGDrug
The drug is 4L-PEG. It will be administered either the day before colonoscopy, or half the day before and half the day of colonoscopy, or the day of colonoscopy.
Patients are prescribed bowel prep according to local clinical practice and then all undergo colonoscopy. No standardized intervention on bowel prep is applied, as the design of the study is observational.
| Study group | Role | What they receive |
|---|---|---|
| 1L-PEG | Hospitalized patients who are prescribed colonoscopy with 1L-polyethylene glycole (PEG) plus ascorbic acid as bowel preparation. Receives: Drug: 1L-PEG | |
| 4L-PEG | Hospitalized patients who are prescribed colonoscopy with 4L-polyethylene glycole (PEG) as bowel preparation. Receives: Drug: 4L-PEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall colon cleansing efficacy
Proportion of patients with adequate colon cleansing (Boston Bowel Preparation Score ≥2 for each colon segment)
Measured: Outcome will be assessed during colonoscopy
Right colon cleansing efficacy
Proportion of patients with adequate colon cleansing in the right colon (Boston Bowel Preparation Score ≥2 in the right colon)
Measured: Outcome is assessed during colonoscopy
Secondary outcomes (7)
Safety (serum sodium imbalance)
Degree of serum sodium shift (mmol/L) before and after bowel preparation
Measured: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (serum potassium imbalance)
Degree of serum potassium shift (mmol/L) before and after bowel preparation
Measured: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (serum calcium imbalance)
Degree of serum calcium shift (mg/dL) before and after bowel preparation
Measured: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (serum magnesium imbalance)
Degree of serum magnesium shift (mg/dL) before and after bowel preparation
Measured: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (serum creatinine imbalance)
Degree of serum creatinine shift (mg/dL) before and after bowel preparation
Measured: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (glomerular filtration rate change)
Degree of change in glomerular filtration rate (mL/min/1.73 m2), before and after bowel preparation
Measured: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (hematocrit change)
Degree of change in hematocrit (%), before and after bowel preparation
Measured: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Feb 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
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 ColonoscopyStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Fuccio, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310332
- Sponsor's protocol ID
- QIPS propensity score matching
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frazzoni L, Spada C, Radaelli F, Mussetto A, Laterza L, La Marca M, Piccirelli S, Cortellini F, Rondonotti E, Paci V, Bazzoli F, Fabbri C, Manno M, Aragona G, Manes G, Occhipinti P, Cadoni S, Zagari RM, Hassan C, Fuccio L. 1L- vs. 4L-Polyethylene glycol for bowel preparation before colonoscopy among inpatients: A propensity score-matching analysis. Dig Liver Dis. 2020 Dec;52(12):1486-1493. doi: 10.1016/j.dld.2020.10.006. Epub 2020 Oct 21.
PubMed 33250131
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1L- vs. 4L-Polyethylene Glycol for Bowel Preparation Before Colonoscopy Among Inpatients: a Propensity Score-matching Analysis.
- ClinicalTrials.gov ID
- NCT04310332
- Acronym / sponsor ID
- QIPS propensity score matching
- Conditions
- Colonoscopy, Hospitalized Patients, Bowel Preparation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 17 Mar 2020 (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.
Background and aims: Inpatients are at high risk for inadequate colon cleansing. Experts recommend 4L-polyethylene-glycol (PEG) solution because of its effectiveness and safety profile. A higher colon cleansing adequacy rate for a hyperosmolar 1L-PEG plus ascorbate prep has been recently reported in an observational study among more than 1,000 inpatients. Thus, the present study is aimed at determining whether 1L-PEG outperforms 4L-PEG among inpatients, through a propensity score-matching between the two groups in order to correct for confounders.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1L-PEG | – | Drug: 1L-PEGHospitalized patients who are prescribed colonoscopy with 1L-polyethylene glycole (PEG) plus ascorbic acid as bowel preparation. |
| 4L-PEG | – | Drug: 4L-PEGHospitalized patients who are prescribed colonoscopy with 4L-polyethylene glycole (PEG) as bowel preparation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients who are scheduled a colonoscopy as inpatients.
Key inclusion criteria (1 listed)
- Adult inpatients scheduled for colonoscopy for any indication within the normal process of care.
Key exclusion criteria (2 listed)
- patients who underwent emergency or elective therapeutic colonoscopies (e.g. polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection)
- patients who underwent bowel preparation outside the hospital
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 |
|---|---|---|
| 1L-PEGThe drug is 1L-PEG plus ascorbic acid (Plenvu®). It will be administered either the day before colonoscopy, or half the day before and half the day of colonoscopy, or the day of colonoscopy. Patients are prescribed bowel prep according to local clinical practice and then all undergo colonoscopy. No standardized intervention on bowel prep is applied, as the design of the study is observational. | Drug | 1L-PEG |
| 4L-PEGThe drug is 4L-PEG. It will be administered either the day before colonoscopy, or half the day before and half the day of colonoscopy, or the day of colonoscopy. Patients are prescribed bowel prep according to local clinical practice and then all undergo colonoscopy. No standardized intervention on bowel prep is applied, as the design of the study is observational. | Drug | 4L-PEG |
Primary outcome
Overall colon cleansing efficacy
Time frame: Outcome will be assessed during colonoscopy
Proportion of patients with adequate colon cleansing (Boston Bowel Preparation Score ≥2 for each colon segment)
Right colon cleansing efficacy
Time frame: Outcome is assessed during colonoscopy
Proportion of patients with adequate colon cleansing in the right colon (Boston Bowel Preparation Score ≥2 in the right colon)
7 secondary outcomes
Safety (serum sodium imbalance)
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (serum potassium imbalance)
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (serum calcium imbalance)
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (serum magnesium imbalance)
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (serum creatinine imbalance)
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (glomerular filtration rate change)
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Safety (hematocrit change)
Time frame: within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
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 17 Mar 2020.
- Derived from this study: PubMed 33250131Frazzoni L, Spada C, Radaelli F, Mussetto A, Laterza L, La Marca M, Piccirelli S, Cortellini F, Rondonotti E, Paci V, Bazzoli F, Fabbri C, Manno M, Aragona G, Manes G, Occhipinti P, Cadoni S, Zagari RM, Hassan C, Fuccio L. 1L- vs. 4L-Polyethylene glycol for bowel preparation before colonoscopy among inpatients: A propensity score-matching analysis. Dig Liver Dis. 2020 Dec;52(12):1486-1493. doi: 10.1016/j.dld.2020.10.006. Epub 2020 Oct 21.
- Individual participant dataSharing planned: No
Related trials for Colonoscopy
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy and Hospitalized Patients, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 10 sites 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 2 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Overall colon cleansing efficacy (time frame: Outcome will be assessed during colonoscopy). The study lists 2 primary outcomes in all. 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 NCT04310332, 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 Mar 2020.