Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 6:48 PM
Study NCT ID:
NCT05192551
Status:
COMPLETED
Last Update Posted:
2022-07-08
First Post:
2021-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Satisfaction and Efficacy of Different PEG-based Bowel Preparations- an Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-06', 'studyFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2021-12-30', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction with bowel prep', 'timeFrame': 'Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy', 'description': 'When arriving to the endoscopy unit the patients fills in a questionnaire about their bowel-prep experience concerning; smell, taste, overall experience (five graded scales) of the prep. The higher the number are the more satisfied the patient are with the current experience (smell, taste and overall experience.\n\nIn the questionnaire they are also asked how much of the prescribed bowel-prep they have digested and how much extra fluid they have been drinking during the preparation process (0-4 litres).'}, {'measure': 'Efficacy of the bowel prep', 'timeFrame': 'Day 1,Directly after the colonoscopy,', 'description': 'Immediately after the colonoscopy the gastroenterologist who has performed the investigation fills in the Boston Bowel Preparation Scale,a widely used scale describing how clean the bowel is in each of the three segment ant in total. Each segment is graded form 0-3 (3 perfect cleaning) and a sum-score of 0-9 (9 perfect clening) is calculated. The higher the number the better the cleansing are'}], 'secondaryOutcomes': [{'measure': 'Differences in the reported frequency of nausea and vomiting during the bowel-preparation process', 'timeFrame': 'Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy', 'description': 'The patients are asked if they have been experienced nausea or been vomiting (yes /no)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bowel-prep', 'Colonoscopy', 'Patient satisfaction'], 'conditions': ['Patient Satisfaction and Efficacy of Bowel-preparation']}, 'descriptionModule': {'briefSummary': 'An multi-center, observational study where we compare the current standard, PEG-based bowel-prep to a (in Sweden) recently approved and introduced low volume (1 litre) PEG-based bowel-prep (Plenvu) in a clinical routine situation.\n\nThe investigators will investigate if there are any differences in patient satisfaction and efficacy of the different bowel preparations', 'detailedDescription': 'When performing Colonoscopy it is essential to use a bowel-prep that is highly effective and at the same time tolerable to intake for the patient to ensure that the patients intakes the recommended amount of the bowel-prep.\n\nThis in order to be able to detect pathological findings in the mucosa. Currently in n Sweden the standard bowel-prep used in most endoscopy-units is high volume bowel preps (4 litres) in split dose. It can be difficult for the patient to intake the whole dose wish can lead to a sub-optimal bowel-cleansing.\n\nRecently, in Sweden, a new low-volume bowel-prep has been approved and introduced (Plenvu).\n\nThis preparation, totally 1 litre of bowel prep given in a split dose is potentially easier for the patient to intake but it is essentially to ensure that the efficacy i at least as good as the current high dose preparation. In this study the investigators will therefore investigate patient satisfaction and efficacy of the different bowel preparations, comparing Plenvu with the current standard bowel-prep regime at the participating endoscopy units.\n\nFive endoscopy units participates in this study (Endoskopi City, Stockholm, Endoskopienheten i Malmö, Endoskopienheten i Linköping, Endoskopienheten i Örebro, Endoskopienheten Ersta sjukhus, Stockholm).\n\nIn each endoscopy unit 100 consecutive patients will be prescribed Plenvu and another 100 consecutive patients will be prescribed the current standard bowel-prep at the actual unit. a total of 1000 patients will participate in the study.\n\nThe currently used bowel-preps at the different endoscopy units are: Vistaprep, Laxabon and Movprep This is a study performed in a clinical context and no randomization is made. When arriving to the endoscopy unit patients are asked to participate in the study and if willing to participate patients will sign an informed consent-form.\n\nBefore the colonoscopy the patients fills in a questionnaire about the bowel-prep experience concerning; smell, taste, overall experience (five graded scales) of the prep. In the questionnaire patients are also asked how much of the prescribed bowel-prep that have been digested and how much extra fluid the patient have been drinking during the preparation process. The patients are also asked about if they have been experienced nausea or been vomiting.\n\nAfter the colonoscopy, the gastroenterologist performing the endoscopy fills in the Boston Bowel Preparation Scale (BBPS) as a measure of how successful the bowel cleansing has been.\n\nBased on this information the investigators will compare patient satisfaction and efficacy of the bowel-cleansing in the group that has been prescribed Plenvu to the group that has been prescribed the endoscopy-units standard bowel-prep'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that are scheduled for a routine colonoscopy at the endoscopy unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients over 18 admitted for colonoscopy at the participating endoscopy-units.\n\nExclusion Criteria:\n\n* Renal failure or other contraindication for using low-dose bowel-preps\n* not speking or reading swedish\n* Need for a translator'}, 'identificationModule': {'nctId': 'NCT05192551', 'briefTitle': 'Patient Satisfaction and Efficacy of Different PEG-based Bowel Preparations- an Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Comparison of Patient Satisfaction and Efficacy of Different PEG-based Bowel Preparations- an Observational Study in Five Endoscopy Units in Sweden', 'orgStudyIdInfo': {'id': 'Bowelprep'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Plenvu', 'description': 'A new type of low-volume bowel-prep recently approved and introduced in the Swedish market. The dose is 500 ml x 2, The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy.', 'interventionNames': ['Other: Bowel-prep (Plenvu as experimental arm)']}, {'label': 'Laxabon', 'description': 'A standard high volume bowel-prep, used for a long time in Sweden. The dose is 2000 ml x 2. The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy.', 'interventionNames': ['Other: Bowel-prep (Plenvu as experimental arm)']}, {'label': 'Vistaprep', 'description': 'A standard high volume bowel-prep, used for a long time in Sweden. The dose is 2000 ml x 2. The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy.', 'interventionNames': ['Other: Bowel-prep (Plenvu as experimental arm)']}, {'label': 'Movprep', 'description': 'A standard median volume bowel-prep, used for a long time in Sweden. The dose is 1000 ml x 2. The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy.', 'interventionNames': ['Other: Bowel-prep (Plenvu as experimental arm)']}], 'interventions': [{'name': 'Bowel-prep (Plenvu as experimental arm)', 'type': 'OTHER', 'otherNames': ['Laxabon,', 'Vistaprep', 'Movprep'], 'description': "In this study we will investigate the efficacy and patient satisfaction of the,in Sweden recently approved and introduced low-dose, Peg-based bowel-prep Plenvu in comparsion with the standard bowel-preps used i today's clinical routine", 'armGroupLabels': ['Laxabon', 'Movprep', 'Plenvu', 'Vistaprep']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58185', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Universitetssjukhuset Linköping', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '21428', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Skåne Universitetssjukhus', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '701 85', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Universitetssjukhuset Örebro', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': '11137', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Aleris GastromottagningenCity', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '11628', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Ersta sjukhus', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Perjohan Lindfors', 'investigatorAffiliation': 'Karolinska Institutet'}}}}