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Risk Factor Assessment for the Development of Surgical Site Infection in Patients Undergoing Colorectal Cancer Surgery

Risk Factor Assessment for Surgical Site Infection After Colorectal Cancer Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07104903
Enrollment
62
Registered
2025-08-05
Start date
2024-12-19
Completion date
2025-04-22
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Surgical Site Infections

Brief summary

Surgical site infection (SSI) is a common complication following colorectal cancer (CRC) surgery and represents a significant cause of slower postoperative recovery and prolonged hospital stay. Therefore, this study aims to determine which risk factors contribute most to SSI development, and to assess the effectiveness of SENIC and NNIS scores in evaluating SSI risk after CRC surgery. This retrospective observational cohort study is conducted at the Oncology Institute of Vojvodina. Sixty-two patients are included, undergoing elective CRC surgery between 03.06.2024. and 31.10.2024. Data are collected from the information system and medical records, including demographic characteristics, presence of SSI, comorbidities, data regarding neoadjuvant oncological therapy, preoperative laboratory findings, type and duration of surgical intervention, perioperative complications, and SENIC and NNIS scores are calculated. The study is supported by a Collegium Talentum scholarship from the Ministry of Human Capacities (Hungarian Government), for the 2024/2025 academic year (recipient Nora Mihalek, MD). Contact: Nora Mihalek, MD Oncology Institute of Vojvodina, Department for Anesthesiology with Reanimatology, Sremska Kamenica, Serbia; University of Novi Sad, Faculty of Medicine, Novi Sad, Serbia

Interventions

Data are collected from the information system and medical records, including demographic characteristics, presence of surgical site infection, comorbidities, data regarding neoadjuvant oncological therapy, preoperative laboratory findings, type and duration of surgical intervention, perioperative complications, and SENIC and NNIS scores are calculated.

Sponsors

Oncology Institute of Vojvodina
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients (˃ 18 years of age) * ASA III clinical status * Patients undergoing radical surgical treatment of colorectal cancer

Exclusion criteria

\- Patients undergoing palliative surgical treatment of colorectal cancer

Design outcomes

Primary

MeasureTime frameDescription
Incidence of surgical site infectionDuring hospital stay (assessed up to 15 days)Data collected from medical records and information system

Secondary

MeasureTime frameDescription
Incidence of particular risk factors for the development of surgical site infection (diabetes mellitus, anaemia, neoadjuvant chemotherapy, neoadjuvant radiotherapy)Baseline
Incidence of particular risk factors for the development of surgical site infection (red blood cell transfusion, length of intervention > 3 hours, contaminated wound, ClassIntra classification, stoma formation)Perioperative/Periprocedural
Study on the Efficacy of Nosocomial Infection Control (SENIC) scoreBaselineMaximal value: 4; Minimal value: 0 (higher score indicates worse outcome)
National Nosocomial Infection Surveillance (NNIS) scoreBaselineMaximal value: 3; Minimal value: 0 (higher score indicates worse outcome)

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026