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NCT Number: NCT07249333

Perioperative Complications After Neoadjuvant Radiotherapy for Colorectal Cancer

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oncology Institute of Vojvodina

Kamenitz, Vojvodina, 21204, Serbia

Location status: Recruiting

Location contact

Nora Mihalek, MD

CONTACT

[email protected]

+381 62 343 159

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of particular perioperative complications (surgical site infection, urinary infection, wound dehiscence, bowel anastomosis dehiscence, ileus, reoperation)

    Time frame: During hospital stay (assessed up to 15 days)

    Data collected from medical records and information system

Secondary outcomes

  1. ClassIntra classification of intraoperative adverse events

    Time frame: Perioperative/Periprocedural

    Maximal value: 5; Minimal value: 0 (higher score indicates worse outcome)

  2. Clavien-Dindo classification of postoperative adverse events

    Time frame: During hospital stay (assessed up to 15 days)

    Maximal value: 5; Minimal value: 1 (higher score indicates worse outcome)

  3. HARM (Hospital stay, Readmission, Mortality) scale of postoperative adverse events

    Time frame: During hospital stay (assessed up to 15 days)

    Maximal value: 5; Minimal value: 0 (higher score indicates worse outcome)

  4. Length of hospital stay

    Time frame: During hospital stay (assessed up to 15 days)

    Number of days spent in hospital

  5. Length of intensive care unit stay

    Time frame: During hospital stay (assessed up to 15 days)

    Number of days spent in the intensive care unit

  6. Duration of antibiotic use (Days of Therapy - DOT)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nora Mihalek, MD

CONTACT

[email protected]

+381 62 343 159

Sponsors and collaborators

Lead sponsor

Oncology Institute of Vojvodina

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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