Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-29 @ 10:56 PM
Study NCT ID:
NCT03578692
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2018-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indicators Predicting Surgery in Acute Severe Ulcerative Colitis(ASUC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-04', 'studyFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2018-07-04', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colon operation', 'timeFrame': '30 days', 'description': '100% direct approximation of inevitable surgery'}], 'secondaryOutcomes': [{'measure': 'No response to medical treatments', 'timeFrame': '5 days', 'description': 'Medical treatments involve glucocorticoids, Immunosuppressant and biologicals for ulcerative colitis. The Oxford Index measured everyday, consisting of CRP and stool frequency, is used to evaluate the response to the treatment. If the Oxford Index does not reduce after 5-day medical treatment, this situation is deemed as no response to medical treatment'}, {'measure': '30-day mortality', 'timeFrame': '30 days', 'description': 'All-cause mortality within 30 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute severe ulcerative colitis', 'predictive indicator', 'surgery'], 'conditions': ['Ulcerative Colitis Acute', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Acute severe ulcerative colitis \\[ASUC\\] patients have high risk of no response to medical treatments and might miss the best timing for surgery when waiting for the medical response. Thus, we investigated whether biomarkers which could early predict the surgery risk of patients with ASUC on admission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All acute severe ulcerative colitis patients were admitted in hospital and prospectively followed during the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe inclusion criterion was patients clearly diagnosed as acute severe ulcerative colitis.\n\nExclusion Criteria:\n\nPatients younger than 18 years-of-age, complicated with malignancy in colon and pregnant were excluded.'}, 'identificationModule': {'nctId': 'NCT03578692', 'briefTitle': 'Indicators Predicting Surgery in Acute Severe Ulcerative Colitis(ASUC)', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing PLA General Hospital'}, 'officialTitle': 'Clinical Value of Inflammation-related Indicators of Blood and Fecal Calprotectin in Predicting the Surgery Rate of Acute Severe Ulcerative Colitis', 'orgStudyIdInfo': {'id': '2018NLY052'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgery group', 'description': 'The protocol for patients assigned to surgery group was as follows. ASUC patients were admitted in, estimated their baseline situations and tested their blood and fecal indicators including PCT, IL-6 and FC on admission. All patients were treated according to the ECCO guideline 2012. Patients who showed bad response to medicine (glucocorticoid for 5 days and rescue therapy for 3 days) were recommended and classified in the surgery group. Their baseline manifestations were collected and compared with the medical group, to exploit the baseline indicators with great sensitive and specificity predicting the high risk for surgery.'}, {'label': 'Medical group', 'description': 'The protocol for patients assigned to medical group was as follows. ASUC patients were admitted in, estimated their baseline situations and tested their blood and fecal indicators including PCT, IL-6 and FC on admission. All patients were treated according to the ECCO guideline 2012. Patients who showed response to medicine (glucocorticoid for 5 days or rescue therapy for 3 days) were classified in the medical group. Their baseline manifestations were collected and compared with the surgery group.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gao Tao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Gao Tao', 'investigatorAffiliation': 'Nanjing PLA General Hospital'}}}}