Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-28 @ 2:23 AM
Study NCT ID:
NCT04497935
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2020-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Preparations for the Study of the Colon Through Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'C520497', 'term': 'MoviPrep'}], '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_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 613}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-07-31', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of bowel preparation between the two groups of patients', 'timeFrame': 'Patients were instructed to report any possible adverse events for up to 1 month after the procedure.', 'description': 'The colonoscopist assessed each of the 3 colon segments on the BBPS and assigned each a score of 0 to 3. Successful overall bowel preparation is defined as a BBPS score of \\>6 with no individual segment scoring \\<2.'}], 'secondaryOutcomes': [{'measure': 'Degree of satisfaction with the two bowel preparation', 'timeFrame': 'Patients were instructed to report any possible adverse events for up to 1 month after the procedure.', 'description': 'The level of patient satisfaction with the 2 bowel preparation regimens was also assessed through a comparative analysis of the patient satisfaction questionnaire'}, {'measure': 'Quality of bowel preparation in patients who had a morning or afternoon colonoscopy and those who received written, oral and additional telephone re-education on the day before the colonoscopy versus written and oral information only.', 'timeFrame': 'Patients were instructed to report any possible adverse events for up to 1 month after the procedure.', 'description': 'The colonoscopist assessed each of the 3 colon segments on the BBPS and assigned each a score of 0 to 3. Successful overall bowel preparation is defined as a BBPS score of \\>6 with no individual segment scoring \\<2.'}]}, 'conditionsModule': {'keywords': ['Bowel preparation', 'Colonoscopy', 'Laxative'], 'conditions': ['Colon Cancer', 'Colon Polyp', 'Colon Adenoma', 'Colon Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'Compare the quality of bowel preparation between two groups of patients, who will undergo two different preparations: 1. Moviprep + diet; 2. Plenvu + diet', 'detailedDescription': 'The quality of bowel preparation is essential for the success of a colonoscopy, reducing colonoscopy duration, and increasing the rate of cecal intubation and of polyp detection. There are several types of preparations available on the market and, irrespective of the choice, the split-dose regimen should be followed. A reduced volume preparation makes the process easier and more tolerable, increasing adhesion. Regarding the diet to be applied before the examination, there are no advantages to a liquid diet compared to a low fiber diet, and there is no evidence on the duration of the diet. In addition, a restrictive diet has an impact on satisfaction and also on adherence to treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients aged \\> 18 years and indicated for a colonoscopy requiring bowel preparation in the Gastroenterology Service of the Hospital of Senhora da Oliveira - Guimarães.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients aged \\> 18 years and indicated for examination requiring bowel preparation\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients with gastroparesis or gastric obstruction.\n* Patients with psychiatric disorders\n* Severe renal impairment with CrCl \\<30mL/min\n* Class III-IV Heart Failure\n* Dependence / use of laxatives\n* Chronic constipation (\\<3 stools/week).\n* Uncontrolled hypertension (SBP \\>170mmHg or DBP \\>100mmHg)\n* Intestinal Obstruction\n* Colostomy from previous intestinal surgery\n* Severe ascites\n* Refusal of participation in the study\n* Patients unable to understand or respond to the satisfaction survey'}, 'identificationModule': {'nctId': 'NCT04497935', 'briefTitle': 'Comparison of Two Preparations for the Study of the Colon Through Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Unidade Local de Saúde do Alto Ave, EPE'}, 'officialTitle': 'Comparative, Prospective and Randomized Study of Two Preparations for the Study of the Colon Through Colonoscopy', 'orgStudyIdInfo': {'id': 'PLNV012018'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1LPEG', 'description': 'Patients receiving 1LPEG who had a colonoscopy in the morning were advised to follow a day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, they prepared the Dose 1 sachet in 500 mL of water and consumed it over a period of 30 minutes, followed by 500 mL of clear liquids. The second dose was then taken at 11:00 pm by mixing the two Dose 2 sachets in a single glass of 500 mL of water and consuming them over 30 minutes, followed by 500 mL of clear liquids. If the colonoscopy was scheduled for the afternoon, the same dosing instructions were given, but the first dose was taken at 7:00 am on the day of the procedure, and the second dose began at 10:00 am.', 'interventionNames': ['Drug: PLENVU']}, {'label': '2LPEG', 'description': 'Patients receiving 2LPEG who had a colonoscopy in the morning were asked to follow a similar day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, the first 1L dose was consumed over a 1-hour period, followed by the second dose at 11:00 pm. For 2LPEG patients with procedures in the afternoon, they took Dose 1 at 7:00 am and Dose 2 at 10:00 am. Any patient receiving 2LPEG was also told to consume 1L of clear liquids during the preparation procedure.', 'interventionNames': ['Drug: MoviPrep']}], 'interventions': [{'name': 'PLENVU', 'type': 'DRUG', 'description': 'Bowel preparation for a colonoscopy', 'armGroupLabels': ['1LPEG']}, {'name': 'MoviPrep', 'type': 'DRUG', 'description': 'Bowel preparation for a colonoscopy', 'armGroupLabels': ['2LPEG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guimarães', 'country': 'Portugal', 'facility': 'Hospital Senhora da Oliveira', 'geoPoint': {'lat': 41.44443, 'lon': -8.29619}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unidade Local de Saúde do Alto Ave, EPE', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cátia Vanessa Meixedo Arieira', 'investigatorAffiliation': 'Unidade Local de Saúde do Alto Ave, EPE'}}}}