Colorectal Cancer, Neoadjuvant Radiotherapy, Perioperative Complication
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Oncology Institute of Vojvodina
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of particular perioperative complications (surgical site infection, urinary infection, wound dehiscence, bowel anastomosis dehiscence, ileus, reoperation) | During hospital stay (assessed up to 15 days) | Data collected from medical records and information system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clavien-Dindo classification of postoperative adverse events | During hospital stay (assessed up to 15 days) | Maximal value: 5; Minimal value: 1 (higher score indicates worse outcome) |
| HARM (Hospital stay, Readmission, Mortality) scale of postoperative adverse events | During hospital stay (assessed up to 15 days) | Maximal value: 5; Minimal value: 0 (higher score indicates worse outcome) |
| ClassIntra classification of intraoperative adverse events | Perioperative/Periprocedural | Maximal value: 5; Minimal value: 0 (higher score indicates worse outcome) |
| Length of intensive care unit stay | During hospital stay (assessed up to 15 days) | Number of days spent in the intensive care unit |
| Duration of antibiotic use (Days of Therapy - DOT) | During hospital stay (assessed up to 15 days) | 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. |
| Length of hospital stay | During hospital stay (assessed up to 15 days) | Number of days spent in hospital |
Countries
Serbia
Contacts
Primary ContactNora Mihalek, MD
Outcome results
None listed