Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT07249333
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative Complications After Neoadjuvant Radiotherapy for Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of particular perioperative complications (surgical site infection, urinary infection, wound dehiscence, bowel anastomosis dehiscence, ileus, reoperation)', 'timeFrame': 'During hospital stay (assessed up to 15 days)', 'description': 'Data collected from medical records and information system'}], 'secondaryOutcomes': [{'measure': 'ClassIntra classification of intraoperative adverse events', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Maximal value: 5; Minimal value: 0 (higher score indicates worse outcome)'}, {'measure': 'Clavien-Dindo classification of postoperative adverse events', 'timeFrame': 'During hospital stay (assessed up to 15 days)', 'description': 'Maximal value: 5; Minimal value: 1 (higher score indicates worse outcome)'}, {'measure': 'HARM (Hospital stay, Readmission, Mortality) scale of postoperative adverse events', 'timeFrame': 'During hospital stay (assessed up to 15 days)', 'description': 'Maximal value: 5; Minimal value: 0 (higher score indicates worse outcome)'}, {'measure': 'Length of hospital stay', 'timeFrame': 'During hospital stay (assessed up to 15 days)', 'description': 'Number of days spent in hospital'}, {'measure': 'Length of intensive care unit stay', 'timeFrame': 'During hospital stay (assessed up to 15 days)', 'description': 'Number of days spent in the intensive care unit'}, {'measure': 'Duration of antibiotic use (Days of Therapy - DOT)', 'timeFrame': 'During hospital stay (assessed up to 15 days)', 'description': 'Number of days when antibiotic therapy was applied. In the case of multiple antibiotic administration, each antibiotic is counted separately and DOT is the sum of each antibiotic therapy duration in days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Neoadjuvant Radiotherapy', 'Perioperative Complication']}, 'descriptionModule': {'briefSummary': 'Neoadjuvant radiotherapy plays an important role in the treatment of locally advanced colorectal cancer. Although radiation therapy is extremely important in reducing the tumor mass, downstaging, and therefore providing conditions for curative surgery, neoadjuvant therapy can increase the risk of perioperative complications, which can lead to slower patient recovery, greater perioperative morbidity, prolonged hospitalization, and increased treatment costs.\n\nThe aim of the study is to determine whether there is a difference in the incidence of perioperative complications after radical colorectal cancer surgery between patients who received neoadjuvant radiotherapy and those patients who did not undergo neoadjuvant radiation.\n\nData is collected from the medical documentation and information system of the Oncology Institute of Vojvodina. Demographic characteristics of patients, comorbidities, length of hospital stay, length of treatment in the intensive care unit, occurrence of complications in the perioperative period, as well as data on neoadjuvant therapy are analyzed. All included patients are of similar general condition, as determined by the CFS (Clinical Frailty Scale). Intraoperative complications are graded using the ClassIntra classification of intraoperative adverse events, and the presence of postoperative adverse events are assessed and classified using the Clavien-Dindo classification of postoperative complications and the HARM (HospitAl stay, Readmission, Mortality rate) score.'}, '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 01.06.2024. and 30.06.2026. in the Oncology Institute of Vojvodina.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (over 18 years of age)\n* Clinical Frailty Scale 2, 3 or 4 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': 'NCT07249333', 'briefTitle': 'Perioperative Complications After Neoadjuvant Radiotherapy for Colorectal Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Oncology Institute of Vojvodina'}, 'officialTitle': 'Effect of Neoadjuvant Radiotherapy on the Incidence of Perioperative Complications After Radical Surgical Treatment of Colorectal Cancer', 'orgStudyIdInfo': {'id': '4/25/1-2086/2-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neoadjuvant radiotherapy group', 'description': 'Patients who underwent radiotherapy before the surgical treatment of colorectal cancer'}, {'label': 'Control group', 'description': 'Patients who did not undergo radiotherapy before the surgical treatment of colorectal cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21204', 'city': 'Kamenitz', 'state': 'Vojvodina', 'status': 'RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Nora Mihalek, MD', 'role': 'CONTACT', 'email': 'noramihalek@gmail.com', 'phone': '+381 62 343 159'}], 'facility': 'Oncology Institute of Vojvodina', 'geoPoint': {'lat': 45.22334, 'lon': 19.84263}}], 'centralContacts': [{'name': 'Nora Mihalek, MD', 'role': 'CONTACT', 'email': 'noramihalek@gmail.com', 'phone': '+381 62 343 159'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oncology Institute of Vojvodina', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asist. Dr.', 'investigatorFullName': 'Nora Mihalek', 'investigatorAffiliation': 'Oncology Institute of Vojvodina'}}}}