Perioperative Complications After Neoadjuvant Radiotherapy for Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Neoadjuvant Radiotherapy, Perioperative Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Serbia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Neoadjuvant Radiotherapy on the Incidence of Perioperative Complications After Radical Surgical Treatment of Colorectal Cancer
Overview
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. The 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. Data 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.
Primary outcome measures
- Incidence of particular perioperative complications (surgical site infection, urinary infection, wound dehiscence, bowel anastomosis dehiscence, ileus, reoperation) [Time frame: During hospital stay (assessed up to 15 days)]
Secondary outcome measures (6)
- ClassIntra classification of intraoperative adverse events [Time frame: Perioperative/Periprocedural]
- Clavien-Dindo classification of postoperative adverse events [Time frame: During hospital stay (assessed up to 15 days)]
- HARM (Hospital stay, Readmission, Mortality) scale of postoperative adverse events [Time frame: During hospital stay (assessed up to 15 days)]
- Length of hospital stay [Time frame: During hospital stay (assessed up to 15 days)]
- Length of intensive care unit stay [Time frame: During hospital stay (assessed up to 15 days)]
- Duration of antibiotic use (Days of Therapy - DOT) [Time frame: During hospital stay (assessed up to 15 days)]
Eligibility criteria
Inclusion criteria
- Adult patients (over 18 years of age)
- Clinical Frailty Scale 2, 3 or 4 status
- Patients undergoing radical surgical treatment of colorectal cancer
Exclusion criteria
- Patients undergoing palliative surgical treatment of colorectal cancer
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Serbia · 1 center
- Oncology Institute of Vojvodina — Kamenitz
Identifiers
NCT: NCT07249333 · 4/25/1-2086/2-2