Perioperative Complications After Neoadjuvant Radiotherapy for Colorectal Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOncology Institute of Vojvodina

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Adult patients (over 18 years of age)

Clinical Frailty Scale 2, 3 or 4 status

Patients undergoing radical surgical treatment of colorectal cancer

Disqualifiers

Patients undergoing palliative surgical treatment of colorectal cancer

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Neoadjuvant radiotherapy group
Group B: Control group

Trial outcomes

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

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

Secondary outcomes

1

ClassIntra classification of intraoperative adverse events

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

Time frame
Perioperative/Periprocedural
2

Clavien-Dindo classification of postoperative adverse events

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

Time frame
During hospital stay (assessed up to 15 days)
3

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

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

Time frame
During hospital stay (assessed up to 15 days)
4

Length of hospital stay

Number of days spent in hospital

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

Other outcomes

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