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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant radiotherapy group | Patients who underwent radiotherapy before the surgical treatment of colorectal cancer | ||
| Control group | Patients who did not undergo radiotherapy before the surgical treatment of colorectal cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of particular perioperative complications (surgical site infection, urinary infection, wound dehiscence, bowel anastomosis dehiscence, ileus, reoperation) | Data collected from medical records and information system | During hospital stay (assessed up to 15 days) |
| Measure | Description | Time Frame |
|---|---|---|
| ClassIntra classification of intraoperative adverse events | Maximal value: 5; Minimal value: 0 (higher score indicates worse outcome) | Perioperative/Periprocedural |
| Clavien-Dindo classification of postoperative adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective radical colorectal cancer surgery in the period between 01.06.2024. and 30.06.2026. in the Oncology Institute of Vojvodina.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nora Mihalek, MD | Contact | +381 62 343 159 | noramihalek@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Institute of Vojvodina | Recruiting | Kamenitz | Vojvodina | 21204 | Serbia |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Maximal value: 5; Minimal value: 1 (higher score indicates worse outcome)
| During hospital stay (assessed up to 15 days) |
| HARM (Hospital stay, Readmission, Mortality) scale of postoperative adverse events | Maximal value: 5; Minimal value: 0 (higher score indicates worse outcome) | During hospital stay (assessed up to 15 days) |
| Length of hospital stay | Number of days spent in hospital | During hospital stay (assessed up to 15 days) |
| Length of intensive care unit stay | Number of days spent in the intensive care unit | During hospital stay (assessed up to 15 days) |
| Duration of antibiotic use (Days of Therapy - DOT) | 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. | During hospital stay (assessed up to 15 days) |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |