Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 6:15 AM
Study NCT ID:
NCT04310332
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2020-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
1L- vs. 4L-PEG for Bowel Preparation Among Inpatients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1004}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-13', 'studyFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2020-03-13', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall colon cleansing efficacy', 'timeFrame': 'Outcome will be assessed during colonoscopy', 'description': 'Proportion of patients with adequate colon cleansing (Boston Bowel Preparation Score ≥2 for each colon segment)'}, {'measure': 'Right colon cleansing efficacy', 'timeFrame': 'Outcome is assessed during colonoscopy', 'description': 'Proportion of patients with adequate colon cleansing in the right colon (Boston Bowel Preparation Score ≥2 in the right colon)'}], 'secondaryOutcomes': [{'measure': 'Safety (serum sodium imbalance)', 'timeFrame': 'within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy', 'description': 'Degree of serum sodium shift (mmol/L) before and after bowel preparation'}, {'measure': 'Safety (serum potassium imbalance)', 'timeFrame': 'within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy', 'description': 'Degree of serum potassium shift (mmol/L) before and after bowel preparation'}, {'measure': 'Safety (serum calcium imbalance)', 'timeFrame': 'within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy', 'description': 'Degree of serum calcium shift (mg/dL) before and after bowel preparation'}, {'measure': 'Safety (serum magnesium imbalance)', 'timeFrame': 'within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy', 'description': 'Degree of serum magnesium shift (mg/dL) before and after bowel preparation'}, {'measure': 'Safety (serum creatinine imbalance)', 'timeFrame': 'within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy', 'description': 'Degree of serum creatinine shift (mg/dL) before and after bowel preparation'}, {'measure': 'Safety (glomerular filtration rate change)', 'timeFrame': 'within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy', 'description': 'Degree of change in glomerular filtration rate (mL/min/1.73 m2), before and after bowel preparation'}, {'measure': 'Safety (hematocrit change)', 'timeFrame': 'within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy', 'description': 'Degree of change in hematocrit (%), before and after bowel preparation'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonoscopy', 'Hospitalized Patients', 'Bowel Preparation']}, 'referencesModule': {'references': [{'pmid': '33250131', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients who are scheduled a colonoscopy as inpatients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult inpatients scheduled for colonoscopy for any indication within the normal process of care.\n\nExclusion Criteria:\n\n* patients who underwent emergency or elective therapeutic colonoscopies (e.g. polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection)\n* patients who underwent bowel preparation outside the hospital'}, 'identificationModule': {'nctId': 'NCT04310332', 'briefTitle': '1L- vs. 4L-PEG for Bowel Preparation Among Inpatients.', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': '1L- vs. 4L-Polyethylene Glycol for Bowel Preparation Before Colonoscopy Among Inpatients: a Propensity Score-matching Analysis.', 'orgStudyIdInfo': {'id': 'QIPS propensity score matching'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1L-PEG', 'description': 'Hospitalized patients who are prescribed colonoscopy with 1L-polyethylene glycole (PEG) plus ascorbic acid as bowel preparation.', 'interventionNames': ['Drug: 1L-PEG']}, {'label': '4L-PEG', 'description': 'Hospitalized patients who are prescribed colonoscopy with 4L-polyethylene glycole (PEG) as bowel preparation.', 'interventionNames': ['Drug: 4L-PEG']}], 'interventions': [{'name': '1L-PEG', 'type': 'DRUG', 'description': '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.\n\nPatients 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.', 'armGroupLabels': ['1L-PEG']}, {'name': '4L-PEG', 'type': 'DRUG', 'description': '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.\n\nPatients 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.', 'armGroupLabels': ['4L-PEG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bologna', 'country': 'Italy', 'facility': "Policlinico Sant'Orsola-Malpighi", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Digestive Endoscopy Unit, Fondazione Poliambulanza', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Carpi', 'country': 'Italy', 'facility': 'UOSD Gastroenterologia ed Endoscopia Digestiva, Azienda USL di Modena', 'geoPoint': {'lat': 44.78237, 'lon': 10.8777}}, {'city': 'Como', 'country': 'Italy', 'facility': 'Gastroenterology Unit, Valduce Hospital', 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'city': 'Forlì', 'country': 'Italy', 'facility': 'Unit of Gastroenterology and Digestive Endoscopy, Forli-Cesena Hospital, AUSL Romagna', 'geoPoint': {'lat': 44.22177, 'lon': 12.04144}}, {'city': 'Iglesias', 'country': 'Italy', 'facility': 'Digestive Endoscopy Unit, Centro Traumatologico-Ortopedico Hospital', 'geoPoint': {'lat': 39.3092, 'lon': 8.5372}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Department of Gastroenterology, ASST Rhodense, Rho and Garbagnate Milanese Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Novara', 'country': 'Italy', 'facility': 'Gastroenterology and Digestive Endoscopy Unit, Ospedale Maggiore della Carità', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Piacenza', 'country': 'Italy', 'facility': 'Department of Internal Medicine, Gastroenterology and Hepatology Unit, "Guglielmo da Saliceto" Hospital', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'city': 'Ravenna', 'country': 'Italy', 'facility': 'Gastroenterology Unit, S. Maria delle Croci Hospital', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Gastroenterology', 'investigatorFullName': 'Lorenzo Fuccio', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}