Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-28 @ 5:23 PM
Study NCT ID:
NCT03131492
Status:
COMPLETED
Last Update Posted:
2022-09-29
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Dehiscence Markers in Ovarian Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-04-24', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with anastomotic leak detected by elevation of C-reactive protein and procalcitonin levels', 'timeFrame': 'Within the first 30 days after the surgery', 'description': 'To evaluate whether C-reactive protein (CRP) and procalcitonin (PCT) can predict anastomotic leak before early discharge.'}], 'secondaryOutcomes': [{'measure': 'C-reactive protein and procalcitonin measures in patients without complications in ovarian surgery.', 'timeFrame': 'Within the first six days after the surgery', 'description': 'Defining normal range values of C-Reactive Protein and Procalcitonin during postoperative ovarian cancer surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Neoplasms Malignant', 'Anastomotic Leak']}, 'referencesModule': {'references': [{'pmid': '22968068', 'type': 'BACKGROUND', 'citation': 'Trencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd.'}, {'pmid': '22222182', 'type': 'BACKGROUND', 'citation': 'Almeida AB, Faria G, Moreira H, Pinto-de-Sousa J, Correia-da-Silva P, Maia JC. Elevated serum C-reactive protein as a predictive factor for anastomotic leakage in colorectal surgery. Int J Surg. 2012;10(2):87-91. doi: 10.1016/j.ijsu.2011.12.006. Epub 2011 Dec 28.'}, {'pmid': '26136929', 'type': 'BACKGROUND', 'citation': 'Lu Y, Huang S, Li P, Chen B, Liu W, Chen Z, Yin F. Prognostic evaluation of preoperative serum C-reactive protein concentration in patients with epithelial ovarian cancer. Exp Ther Med. 2015 May;9(5):2003-2007. doi: 10.3892/etm.2015.2350. Epub 2015 Mar 12.'}, {'pmid': '23478615', 'type': 'BACKGROUND', 'citation': 'Garcia-Granero A, Frasson M, Flor-Lorente B, Blanco F, Puga R, Carratala A, Garcia-Granero E. Procalcitonin and C-reactive protein as early predictors of anastomotic leak in colorectal surgery: a prospective observational study. Dis Colon Rectum. 2013 Apr;56(4):475-83. doi: 10.1097/DCR.0b013e31826ce825.'}, {'pmid': '26865894', 'type': 'BACKGROUND', 'citation': 'Zawadzki M, Czarnecki R, Rzaca M, Obuszko Z, Velchuru VR, Witkiewicz W. C-reactive protein and procalcitonin predict anastomotic leaks following colorectal cancer resections - a prospective study. Wideochir Inne Tech Maloinwazyjne. 2016 Jan;10(4):567-73. doi: 10.5114/wiitm.2015.56999. Epub 2016 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'EDMOCS trial pretends to evaluate if C-reactive protein (CRP) and procalcitonin (PCT) can predict intestinal anastomotic leaks before early discharge in advanced ovarian cancer surgery requiring intestinal resection. These markers have already been positively tested in colorectal cancer surgery, but not yet in ovarian surgery.\n\nPatients undergoing intestinal resection in ovarian cancer surgery will be included. C-reactive protein and PCT will be measured pre-operatively, and on the second, fourth and sixth postoperative day. Thirty-day readmissions, re-operations and mortality will be recorded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed of an advenced ovarian cancer who need an intestinal resection during ovarian surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ovarian cancer stage III-IV\n* Intestinal resection needed\n\nExclusion Criteria:\n\n* Infection diagnosed at time of surgery.\n* Urgent surgery'}, 'identificationModule': {'nctId': 'NCT03131492', 'acronym': 'EDMOCS', 'briefTitle': 'Early Dehiscence Markers in Ovarian Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Procalcitonin and C-Reactive Protein as Early Anastomotic Dehiscence Markers in Ovarian Cancer Surgery', 'orgStudyIdInfo': {'id': 'PR(AMI)68/2017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood test', 'type': 'DIAGNOSTIC_TEST', 'description': 'C-reactive protein and PCT measured preoperatively, and on the second, fourth and sixth postoperative days.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari de la Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Antonio Gil-Moreno, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Head of Department of Obstetrics and Gynecology, Vall d'Hebron University Hospital"}, {'name': 'Asunción Pérez-Benavente, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of Unit of Gynecology Oncology Department of Obstetrics and Gynecology'}, {'name': 'José Luis Sánchez-Iglesias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics and Gynecology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}