Perioperative Complications After Neoadjuvant Radiotherapy for Colorectal Cancer

NCT07249333 | Recruiting

• 1 other identifier: 4/25/1-2086/2-2
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Neoadjuvant Radiotherapy; Perioperative Complication

Outcome Measures

Primary Outcomes (1)

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

  Data collected from medical records and information system

  During hospital stay (assessed up to 15 days)

Secondary Outcomes (6)

• ClassIntra classification of intraoperative adverse events

  Perioperative/Periprocedural

• Clavien-Dindo classification of postoperative adverse events

  During hospital stay (assessed up to 15 days)

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

  During hospital stay (assessed up to 15 days)

• Length of hospital stay

  During hospital stay (assessed up to 15 days)

• Length of intensive care unit stay

  During hospital stay (assessed up to 15 days)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective radical colorectal cancer surgery in the period between 01.06.2024. and 30.06.2026. in the Oncology Institute of Vojvodina.

You may qualify if:

• Adult patients (over 18 years of age)
• Clinical Frailty Scale 2, 3 or 4 status
• Patients undergoing radical surgical treatment of colorectal cancer

You may not qualify if:

• Patients undergoing palliative surgical treatment of colorectal cancer

Sponsors & Collaborators

• Oncology Institute of Vojvodina: lead

Study Sites (1)

Oncology Institute of Vojvodina

Kamenitz, Vojvodina, 21204, Serbia

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Nora Mihalek, MD

CONTACT

+381 62 343 159; noramihalek@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist. Dr.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: June 18, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)