Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-26 @ 1:51 PM
Study NCT ID:
NCT02784093
Status:
UNKNOWN
Last Update Posted:
2017-08-09
First Post:
2016-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005244', 'term': 'Fecal Impaction'}], 'ancestors': [{'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004733', 'term': 'Enema'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2016-05-24', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the proportion of patients having successful disimpaction', 'timeFrame': '6 days', 'description': 'Successful disimpaction was indicated by the passage of watery stools.'}, {'measure': 'the time when patients having successful disimpaction', 'timeFrame': '6 days', 'description': 'Successful disimpaction was indicated by the passage of watery stools.'}], 'secondaryOutcomes': [{'measure': 'Wexner constipation score', 'timeFrame': '6 days', 'description': 'Severity of constipation symptoms was evaluated according to Wexner constipation scale.'}, {'measure': 'Patient Assessment of Constipation-Symptoms (PAC-SYM) score', 'timeFrame': '6 days', 'description': 'Severity of constipation symptoms was evaluated according to PAC-SYM questionnaire.'}, {'measure': 'Patient Assessment of Constipation Quality of Life (PAC-QOL) score', 'timeFrame': '6 days', 'description': 'Health-related quality of life was assessed using the trial by the PAC-QOL questionnaire.'}, {'measure': 'adverse events and safety', 'timeFrame': '6 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Constipation', 'Fecal impaction', 'Gastrografin', 'Randomized Controlled Trial'], 'conditions': ['Fecal Impaction']}, 'descriptionModule': {'briefSummary': 'Fecal impaction (FI) is a common cause of lower gastrointestinal tract obstruction, and it is the result of chronic or severe constipation and most commonly found in the elderly population. Gastrografin is a water soluble contrast mediate that could act as an osmotic laxative. It has been shown to confer a therapeutic benefit in adhesive small bowel obstruction (SBO). The investigators speculate that gastrografin administrated orally may be more effective than enema in the treatment of fecal impaction induced intestinal obstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A confirmed presence of fecal impaction diagnosed based on the following conditions: large amount of hard stool (impacted faecaloma) in colon or rectum; abdominal radiography was performed for assessment.\n2. Rome III criteria for chronic constipation present for ≥8 weeks.\n\nExclusion Criteria:\n\n1. Patients with a history of colorectal surgery or an organic cause of constipation; pregnancy.\n2. Patients with long-term medical conditions potentially associated with constipation (ie, cystic fibrosis, cerebral palsy, hypothyroidism, spinal and gastric anomalies).\n3. Patients with medical or psychiatric illness.\n4. Patients with abnormal laboratory data or thyroid function.'}, 'identificationModule': {'nctId': 'NCT02784093', 'briefTitle': 'Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation: A Double-blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Gastrografin-FI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exposure Group', 'description': 'Participants were allocated to receive 100 mL of Gastrografin orally once daily for 6 consecutive days.', 'interventionNames': ['Drug: Gastrografin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Participants were allocated to receive enemas twice daily for 6 consecutive days.', 'interventionNames': ['Procedure: enemas']}], 'interventions': [{'name': 'Gastrografin', 'type': 'DRUG', 'armGroupLabels': ['Exposure Group']}, {'name': 'enemas', 'type': 'PROCEDURE', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Ning Li, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinling Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jianfeng Gong', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}