Perioperative Complications After Neoadjuvant Radiotherapy for Colorectal Cancer

NCT ID: NCT07249333

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-18

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Neoadjuvant Radiotherapy Perioperative Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Neoadjuvant radiotherapy group

Patients who underwent radiotherapy before the surgical treatment of colorectal cancer

No interventions assigned to this group

Control group

Patients who did not undergo radiotherapy before the surgical treatment of colorectal cancer

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oncology Institute of Vojvodina

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nora Mihalek

Asist. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oncology Institute of Vojvodina

Kamenitz, Vojvodina, Serbia

Site Status RECRUITING

Countries

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Serbia

Central Contacts

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Nora Mihalek, MD

Role: CONTACT

+381 62 343 159

Facility Contacts

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Nora Mihalek, MD

Role: primary

+381 62 343 159

Other Identifiers

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4/25/1-2086/2-2

Identifier Type: -

Identifier Source: org_study_id

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