Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:08 PM
Study NCT ID:
NCT01933867
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2013-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Water-aided Colonoscopy in Inflammatory Bowel Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-16', 'studyFirstSubmitDate': '2013-08-28', 'studyFirstSubmitQcDate': '2013-08-30', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of unsedated colonoscopy', 'timeFrame': 'at the end of each colonoscopy', 'description': 'Successful unsedated colonoscopy is defined as reaching the cecum by using given insertion technique without administering sedation.'}], 'secondaryOutcomes': [{'measure': 'Discomfort during colonoscopy', 'timeFrame': 'at the end of each colonoscopy', 'description': 'Discomfort level using visual continuous scale 0-10 (0 = no pain, 10 = worst pain).'}, {'measure': 'Cecal intubation time', 'timeFrame': 'while reaching the cecum', 'description': 'Cecal intubation time is defined as time between colonoscope introduction into the anus and reaching the cecum.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['water', 'colonoscopy', 'Crohn´s disease', 'ulcerative colitis'], 'conditions': ['Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '26040317', 'type': 'DERIVED', 'citation': 'Falt P, Smajstrla V, Fojtik P, Urban O, Hill M. Water-Aided Colonoscopy in Inflammatory Bowel Disease Patients-A Randomised, Single-Centre Trial. J Crohns Colitis. 2015 Sep;9(9):720-4. doi: 10.1093/ecco-jcc/jjv093. Epub 2015 Jun 3.'}]}, 'descriptionModule': {'briefSummary': 'Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of lower discomfort and need for sedation during colonoscopy. Patients with inflammatory bowel diseases (IBD) undergo repeated colonoscopy in course of their disease. According to our preliminary experience, water immersion could be beneficial while scoping these patients. As far as the investigators know, water-aided colonoscopy has never been studied in this indication. Results of our trial might support use of water-aided colonoscopy in common practice and decrease associated discomfort in IBD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* known diagnosis of inflammatory bowel disease\n* planned diagnostic outpatient colonoscopy\n* signed informed consent\n* willingness to undergo unsedated colonoscopy\n\nExclusion Criteria:\n\n* ulcerative proctitis\n* bowel resection longer than ileocecal resection\n* requirement for sedation'}, 'identificationModule': {'nctId': 'NCT01933867', 'briefTitle': 'Water-aided Colonoscopy in Inflammatory Bowel Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Vitkovice Hospital'}, 'officialTitle': 'Water-aided Colonoscopy in Patients With Inflammatory Bowel Disease - a Single-center, Single-blinded Randomized Trial', 'orgStudyIdInfo': {'id': 'DDC VN 06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Water immersion colonoscopy', 'description': 'Water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.', 'interventionNames': ['Procedure: Water immersion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Air insufflation colonoscopy', 'description': 'Standard room air insufflation during both colonoscope insertion and withdrawal.', 'interventionNames': ['Procedure: Air insufflation insertion']}], 'interventions': [{'name': 'Water immersion', 'type': 'PROCEDURE', 'description': 'Water immersion means infusion of room temperature water during colonoscope insertion without air insufflation.', 'armGroupLabels': ['Water immersion colonoscopy']}, {'name': 'Air insufflation insertion', 'type': 'PROCEDURE', 'otherNames': ['Room air insufflation during colonoscope insertion.'], 'armGroupLabels': ['Air insufflation colonoscopy']}]}, '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': 'MUDr. Premysl Falt, Ph.D.', 'investigatorFullName': 'Premysl Falt MD', 'investigatorAffiliation': 'Vitkovice Hospital'}}}}