NCT07249333 Perioperative Complications After Neoadjuvant Radiotherapy for Colorectal Cancer
| NCT ID | NCT07249333 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oncology Institute of Vojvodina |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-06-18 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-06-18 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07249333 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07249333 currently recruiting?
Yes, NCT07249333 is actively recruiting participants. Contact the research team at noramihalek@gmail.com for enrollment information.
Where is the NCT07249333 trial being conducted?
This trial is being conducted at Kamenitz, Serbia.
Who is sponsoring the NCT07249333 clinical trial?
NCT07249333 is sponsored by Oncology Institute of Vojvodina. The trial plans to enroll 80 participants.
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