Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT01254435
Status:
COMPLETED
Last Update Posted:
2010-12-06
First Post:
2010-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Positioning During Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'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': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-03', 'studyFirstSubmitDate': '2010-12-03', 'studyFirstSubmitQcDate': '2010-12-03', 'lastUpdatePostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mucosal visualisation', 'timeFrame': '3 months', 'description': 'Made by video assessment of colonoscopic withdrawal'}, {'measure': 'Luminal distension'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Positioning in colonoscopy', 'Quality control'], 'conditions': ['Colonic Polyps']}, 'descriptionModule': {'briefSummary': "Colonoscopy is the gold standard investigation in the screening of colorectal neoplasms. The investigators hypothesise that visualisation of the colonic mucosa on extubation may be improved by changing patient position as follows: left lateral position for the right colon, supine for the transverse colon and right lateral position for the left colon(fixed positioning). The investigators aim to validate our hypothesis by performing a randomised control study, comparing mucosal visualisation in patients placed in the 'routine' positions at the discretion of the endoscopist with visualisation in those placed in the above described positions. The hypothesis is that fixed positioning confers an advantage."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring colonoscopy\n\nExclusion Criteria:\n\n* Polyp surveillance\n* Cancer surveillance\n* Infirmity\n* Pregnancy\n* Colectomy\n* Poor tolerance\n* Failed colonoscopy\n* Poor bowel preparation'}, 'identificationModule': {'nctId': 'NCT01254435', 'briefTitle': 'Positioning During Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'Does Patient Position During Extubation at Colonoscopy Influence the Quality of Mucosal Visualisation?', 'orgStudyIdInfo': {'id': 'STH14709'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "'Free' positioning withdrawal", 'description': 'Withdrawal of the colonoscope with the patient positioned at the discretion of the endoscopist', 'interventionNames': ['Procedure: Colonoscopy']}, {'type': 'EXPERIMENTAL', 'label': "'Fixed' position withdrawal", 'description': 'Patient positioned in the left lateral position to visualise the caecum, ascending colon and hepatic flexure; supine to visualise the transverse colon; and in the right lateral position to visualise the splenic flexure, descending colon and the sigmoid colon', 'interventionNames': ['Procedure: Colonoscopy']}], 'interventions': [{'name': 'Colonoscopy', 'type': 'PROCEDURE', 'description': 'Recording of colonoscopic extubation', 'armGroupLabels': ["'Fixed' position withdrawal", "'Free' positioning withdrawal"]}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S5 7AU', 'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Steven R Brown, MD FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, {'name': 'Stuart Riley, FRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, {'name': 'Wal Baraza, MRCS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sheffield'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Steven Brown', 'oldOrganization': 'Sheffield Teaching Hospitals NHS Trust'}}}}