Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-02-11 @ 3:37 AM
Study NCT ID:
NCT02563132
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2015-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbon Dioxide Insufflation Colonoscopy in IBD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-28', 'studyFirstSubmitDate': '2015-09-28', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bloating score 1 hour after the colonoscopy', 'timeFrame': '1 hour', 'description': 'Bloating severity on continuous scale 0-10 (0 = none, 10 = worst) 1 hour after colonoscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'carbon dioxide', 'inflammatory bowel disease'], 'conditions': ['Colonoscopy', 'Carbon Dioxide', 'Inflammatory Bowel Disease']}, 'descriptionModule': {'briefSummary': 'Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) after the procedure. So far, it has not been studied in inflammatory bowel disease patients. The study was designed to evaluate discomfort after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.', 'detailedDescription': 'Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) during up to 24 hours after the procedure. So far, it has not been studied in inflammatory bowel disease patients who represent specific patient population indicated for colonoscopy. They are characterized by younger age, structural changes of the colon including intestinal resections and need for repeated and frequently difficult procedures.The study was designed to evaluate discomfort during 24 hours after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* known diagnosis of Crohn´s disease and ulcerative colitis\n* indication for diagnostic colonoscopy\n* informed consent\n* unsedated or minimally sedated procedure (\\< 3 mg of midazolam)\n\nExclusion Criteria:\n\n* planned incomplete or therapeutic procedure\n* deep sedation or general anesthesia\n* intestinal resection longer than ileocecal resection\n* isolated gastroduodenal or jejunal location of Crohn´s disease (L4)\n* ulcerative proctitis (E1)'}, 'identificationModule': {'nctId': 'NCT02563132', 'briefTitle': 'Carbon Dioxide Insufflation Colonoscopy in IBD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Vitkovice Hospital'}, 'officialTitle': 'Carbon Dioxide Insufflation Colonoscopy in Inflammatory Bowel Disease Patients', 'orgStudyIdInfo': {'id': 'DDC VN 08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carbon dioxide insufflation colonoscopy (CO2)', 'description': 'Carbon dioxide during both insertion and withdrawal phase of the colonoscopy.', 'interventionNames': ['Procedure: Carbon dioxide insufflation']}, {'type': 'NO_INTERVENTION', 'label': 'Air insufflation colonoscopy (AI)', 'description': 'Air insufflation during both insertion and withdrawal phase of the colonoscopy.'}], 'interventions': [{'name': 'Carbon dioxide insufflation', 'type': 'PROCEDURE', 'description': 'Carbon dioxide insufflation during diagnostic colonoscopy', 'armGroupLabels': ['Carbon dioxide insufflation colonoscopy (CO2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '703 84', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Digestive Diseases Center - Vitkovice Hospital', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vitkovice Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Premysl Falt, M.D., Ph.D.', 'investigatorFullName': 'Premysl Falt, M.D., Ph.D.', 'investigatorAffiliation': 'Vitkovice Hospital'}}}}