Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-03-01 @ 8:56 PM
Study NCT ID:
NCT01946334
Status:
COMPLETED
Last Update Posted:
2014-09-01
First Post:
2013-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Body Position Influence Pressure Recording by High-resolution Manometry ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004688', 'term': 'Encopresis'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-29', 'studyFirstSubmitDate': '2013-09-11', 'studyFirstSubmitQcDate': '2013-09-16', 'lastUpdatePostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anal pressures measured by anorectal manometry and high-resolution three-dimensional', 'timeFrame': '12 months', 'description': 'comparing two positions conventional position in the left lateral decubitus position with the feet.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anal Incontinence or Constipation']}, 'descriptionModule': {'briefSummary': 'The anorectal manometry is the gold standard in the evaluation of anorectal function.\n\nSeveral techniques are currently used (balloons, perfused catheters) and are always performed in the supine position.\n\nFew studies have reported the evaluation of sphincter function in the upright position, whereas symptoms of fecal incontinence occur in this position.\n\nRecently developed, high-resolution manometry, thanks to its many mechanical sensors, allows topographic analysis and evaluation of anorectal function more acurate. In addition, the rigid nature of the probe should allow stability measures / recording, which is not possible with probes perfused catheters example.\n\nWe therefore propose to compare anal sphincter pressure in supine and standing, measured in high-resolution manometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman over the age of 18 years\n* Patient referred for endoscopic ultrasound and anal manometry anorectal HR-3D which is an indication of fecal incontinence or dyschesia\n\nExclusion Criteria:\n\n* Patient age 18 Less\n* Patient trust, guardianship, judicial protection\n* No Written Consent\n* Lack of social insurance\n* History of anorectal surgery\n* A presence of anal stenosis\n* A setting evidence of anorectal lesion preventing the realization of the Screening\n* Motor disability preventing the realization of the anorectal manometry 3D HR-standing situation'}, 'identificationModule': {'nctId': 'NCT01946334', 'briefTitle': 'Does Body Position Influence Pressure Recording by High-resolution Manometry ?', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Does Body Position Influence Pressure Recording by High-resolution Manometry ?', 'orgStudyIdInfo': {'id': '2013-A00507-38'}, 'secondaryIdInfos': [{'id': '2013-13', 'type': 'OTHER', 'domain': 'AP HM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients', 'interventionNames': ['Device: anorectal manometry and high-resolution three-dimensional']}], 'interventions': [{'name': 'anorectal manometry and high-resolution three-dimensional', 'type': 'DEVICE', 'armGroupLabels': ['patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'LOIC MONDOLONI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}