Oncology Institute of Vojvodina
Kamenitz, Vojvodina, 21204, Serbia
Location status: Recruiting
NCT Number: NCT07249333
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Kamenitz, Vojvodina, 21204, Serbia
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During hospital stay (assessed up to 15 days)
Data collected from medical records and information system
Time frame: Perioperative/Periprocedural
Maximal value: 5; Minimal value: 0 (higher score indicates worse outcome)
Time frame: During hospital stay (assessed up to 15 days)
Maximal value: 5; Minimal value: 1 (higher score indicates worse outcome)
Time frame: During hospital stay (assessed up to 15 days)
Maximal value: 5; Minimal value: 0 (higher score indicates worse outcome)
Time frame: During hospital stay (assessed up to 15 days)
Number of days spent in hospital
Time frame: During hospital stay (assessed up to 15 days)
Number of days spent in the intensive care unit
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Oncology Institute of Vojvodina
Other Gov
Effect of Neoadjuvant Radiotherapy on the Incidence of Perioperative Complications After Radical Surgical Treatment of Colorectal Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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