Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-28 @ 4:01 AM
Study NCT ID:
NCT07104903
Status:
COMPLETED
Last Update Posted:
2025-08-05
First Post:
2025-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factor Assessment for the Development of Surgical Site Infection in Patients Undergoing Colorectal Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of surgical site infection', 'timeFrame': 'During hospital stay (assessed up to 15 days)', 'description': 'Data collected from medical records and information system'}], 'secondaryOutcomes': [{'measure': 'Incidence of particular risk factors for the development of surgical site infection (diabetes mellitus, anaemia, neoadjuvant chemotherapy, neoadjuvant radiotherapy)', 'timeFrame': 'Baseline'}, {'measure': 'Incidence of particular risk factors for the development of surgical site infection (red blood cell transfusion, length of intervention > 3 hours, contaminated wound, ClassIntra classification, stoma formation)', 'timeFrame': 'Perioperative/Periprocedural'}, {'measure': 'Study on the Efficacy of Nosocomial Infection Control (SENIC) score', 'timeFrame': 'Baseline', 'description': 'Maximal value: 4; Minimal value: 0 (higher score indicates worse outcome)'}, {'measure': 'National Nosocomial Infection Surveillance (NNIS) score', 'timeFrame': 'Baseline', 'description': 'Maximal value: 3; Minimal value: 0 (higher score indicates worse outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Site Infections', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Surgical site infection (SSI) is a common complication following colorectal cancer (CRC) surgery and represents a significant cause of slower postoperative recovery and prolonged hospital stay. Therefore, this study aims to determine which risk factors contribute most to SSI development, and to assess the effectiveness of SENIC and NNIS scores in evaluating SSI risk after CRC surgery.\n\nThis retrospective observational cohort study is conducted at the Oncology Institute of Vojvodina. Sixty-two patients are included, undergoing elective CRC surgery between 03.06.2024. and 31.10.2024. Data are collected from the information system and medical records, including demographic characteristics, presence of SSI, comorbidities, data regarding neoadjuvant oncological therapy, preoperative laboratory findings, type and duration of surgical intervention, perioperative complications, and SENIC and NNIS scores are calculated.\n\nThe study is supported by a Collegium Talentum scholarship from the Ministry of Human Capacities (Hungarian Government), for the 2024/2025 academic year (recipient Nora Mihalek, MD).\n\nContact: Nora Mihalek, MD Oncology Institute of Vojvodina, Department for Anesthesiology with Reanimatology, Sremska Kamenica, Serbia; University of Novi Sad, Faculty of Medicine, Novi Sad, Serbia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective radical colorectal cancer surgery in the period between 03.06.2024. and 31.10.2024. in the Oncology Institute of Vojvodina.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (˃ 18 years of age)\n* ASA III clinical status\n* Patients undergoing radical surgical treatment of colorectal cancer\n\nExclusion Criteria:\n\n\\- Patients undergoing palliative surgical treatment of colorectal cancer'}, 'identificationModule': {'nctId': 'NCT07104903', 'briefTitle': 'Risk Factor Assessment for the Development of Surgical Site Infection in Patients Undergoing Colorectal Cancer Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Oncology Institute of Vojvodina'}, 'officialTitle': 'Risk Factor Assessment for Surgical Site Infection After Colorectal Cancer Surgery', 'orgStudyIdInfo': {'id': '4/24/3-5228/2-9'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Data collection from medical records', 'type': 'OTHER', 'description': 'Data are collected from the information system and medical records, including demographic characteristics, presence of surgical site infection, comorbidities, data regarding neoadjuvant oncological therapy, preoperative laboratory findings, type and duration of surgical intervention, perioperative complications, and SENIC and NNIS scores are calculated.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21204', 'city': 'Kamenitz', 'state': 'Vojvodina', 'country': 'Serbia', 'facility': 'Oncology Institute of Vojvodina', 'geoPoint': {'lat': 45.22334, 'lon': 19.84263}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oncology Institute of Vojvodina', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Nora Mihalek', 'investigatorAffiliation': 'Oncology Institute of Vojvodina'}}}}