Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT01616602
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2012-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prone Versus Left-sided Colonoscopy in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016684', 'term': 'Prone Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'lastUpdateSubmitDate': '2012-06-11', 'studyFirstSubmitDate': '2012-06-08', 'studyFirstSubmitQcDate': '2012-06-11', 'lastUpdatePostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['patients', 'presenting', 'elective', 'colonoscopy.'], 'conditions': ['Obese']}, 'descriptionModule': {'briefSummary': 'For obese patients, a randomized trial aimed at determining whether colonoscopy performance and patient comfort is improved if a patient is in the prone position (lay on their abdomen) versus the traditional left-sided position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>30kg/m2\n* Elective Colonoscopy\n\nExclusion Criteria:\n\n* Patients with prior colonic resection, strictures, or known colonic or intra-abdominal malignancy.\n* Patients who are scheduled to have monitored or general anesthesia for their procedure.\n* Emergency colonoscopy\n* Inadequate preparation of the colon as assessed during colonoscopy'}, 'identificationModule': {'nctId': 'NCT01616602', 'briefTitle': 'Prone Versus Left-sided Colonoscopy in Obese Patients', 'organization': {'class': 'FED', 'fullName': 'Dallas VA Medical Center'}, 'orgStudyIdInfo': {'id': 'DVAMC-10-098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Left-sided Position', 'interventionNames': ['Other: Standard Position']}, {'type': 'EXPERIMENTAL', 'label': 'Prone Position', 'interventionNames': ['Other: Prone Position']}], 'interventions': [{'name': 'Prone Position', 'type': 'OTHER', 'description': 'Patients were asked to lay on their abdomen for their elective colonoscopy.', 'armGroupLabels': ['Prone Position']}, {'name': 'Standard Position', 'type': 'OTHER', 'description': 'The traditional left-lateral decubitus position', 'armGroupLabels': ['Left-sided Position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dallas VA Medical Center', 'class': 'FED'}}}}