Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-22 @ 1:51 PM
Study NCT ID:
NCT02772692
Status:
UNKNOWN
Last Update Posted:
2016-05-13
First Post:
2016-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defecation Postures for Functional Consumption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2016-05-11', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of defecation', 'timeFrame': 'Six months', 'description': 'Frequency of defecation per week is collected by an interview questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Frequency of re-defecation after the first defecation', 'timeFrame': 'Six months', 'description': 'Frequency of re-defecation after the first defecation per week is collected by an interview questionnaire.'}, {'measure': 'Defecation time', 'timeFrame': 'Six months', 'description': 'Defecation time (minute) is assessed by watch and collected by an interview questionnaire.'}, {'measure': 'Sensation of non-complete defecation', 'timeFrame': 'Six months', 'description': 'Sensation of non-complete defecation is investigated by an interview questionnaire (0: no; 1: yes).'}, {'measure': 'Straining forces during defecation', 'timeFrame': 'Six months', 'description': 'Straining forces during defecation is assessed by the rating of defecation exertion (0-1-2-3: very easy, easy, difficult, very difficult).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Constipation']}, 'referencesModule': {'references': [{'pmid': '12738468', 'type': 'RESULT', 'citation': 'Roberts MC, Millikan RC, Galanko JA, Martin C, Sandler RS. Constipation, laxative use, and colon cancer in a North Carolina population. Am J Gastroenterol. 2003 Apr;98(4):857-64. doi: 10.1111/j.1572-0241.2003.07386.x.'}, {'pmid': '21666546', 'type': 'RESULT', 'citation': 'Lindberg G, Hamid SS, Malfertheiner P, Thomsen OO, Fernandez LB, Garisch J, Thomson A, Goh KL, Tandon R, Fedail S, Wong BC, Khan AG, Krabshuis JH, LeMair A; World Gastroenterology Organisation. World Gastroenterology Organisation global guideline: Constipation--a global perspective. J Clin Gastroenterol. 2011 Jul;45(6):483-7. doi: 10.1097/MCG.0b013e31820fb914. No abstract available.'}, {'pmid': '17026568', 'type': 'RESULT', 'citation': 'Rao SS, Kavlock R, Rao S. Influence of body position and stool characteristics on defecation in humans. Am J Gastroenterol. 2006 Dec;101(12):2790-6. doi: 10.1111/j.1572-0241.2006.00827.x. Epub 2006 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'Whether functional consumption is influenced by defecation postures is unclear. The investigators investigated effects of defecation postures on functional consumption.', 'detailedDescription': 'Constipation is a chronic problem in many patients all over the world. In some groups of patients such as the elderly, constipation is a significant health care problem. A prospective study was performed at 3 hospitals in China. The included patients were functional consumption patients with defecation sitting on a standard-sized toilet. Patients received standard functional consumption treatment according to the guideline and were randomly assigned to groups that using a squatting pan or a standard-sized toilet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has functional constipation\n* Subject does not receive other treatments\n\nExclusion Criteria:\n\n* History of heart cerebrovascular disease\n* History of other types of constipation\n* Pregnant, trying to become pregnant or breast feeding\n* Age\\< 18-year and \\>70-year'}, 'identificationModule': {'nctId': 'NCT02772692', 'briefTitle': 'Defecation Postures for Functional Consumption', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Influence of Defecation Postures on Functional Consumption in Humans', 'orgStudyIdInfo': {'id': '20160511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Squatting pan', 'description': 'Defecation using a squatting pan', 'interventionNames': ['Behavioral: Squatting pan']}, {'type': 'NO_INTERVENTION', 'label': 'Toilet', 'description': 'defecation using a standard-sized toilet'}], 'interventions': [{'name': 'Squatting pan', 'type': 'BEHAVIORAL', 'description': 'Using squatting pans to replace standard-sized toilets in one group of the included constipation patients', 'armGroupLabels': ['Squatting pan']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhanwei Zhao, MD', 'role': 'CONTACT', 'email': 'zzq194910@163.com', 'phone': '+86 18392186936'}], 'overallOfficials': [{'name': 'Qingchuan Zhao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Zhanwei Zhao', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}