Effect of Neoadjuvant Radiotherapy on the Incidence of Perioperative Complications After Radical Surgical Treatment of Colorectal Cancer

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients (over 18 years of age)

• Clinical Frailty Scale 2, 3 or 4 status

• Patients undergoing radical surgical treatment of colorectal cancer

Locations
Other Locations
Serbia
Oncology Institute of Vojvodina
RECRUITING
Kamenitz
Contact Information
Primary
Nora Mihalek, MD
noramihalek@gmail.com
+381 62 343 159
Time Frame
Start Date: 2024-06-18
Estimated Completion Date: 2026-06
Participants
Target number of participants: 80
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Oncology Institute of Vojvodina

This content was sourced from clinicaltrials.gov