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NCT Number: NCT07104903

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

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

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Key information

Conditions

Surgical Site Infections Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Infections Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oncology Institute of Vojvodina

Kamenitz, Vojvodina, 21204, Serbia

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Data collection from medical records

Other

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.

Primary outcomes

  1. Incidence of surgical site infection

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

    Data collected from medical records and information system

Secondary outcomes

  1. Incidence of particular risk factors for the development of surgical site infection (diabetes mellitus, anaemia, neoadjuvant chemotherapy, neoadjuvant radiotherapy)

    Time frame: Baseline

  2. 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)

    Time frame: Perioperative/Periprocedural

  3. Study on the Efficacy of Nosocomial Infection Control (SENIC) score

    Time frame: Baseline

    Maximal value: 4; Minimal value: 0 (higher score indicates worse outcome)

  4. National Nosocomial Infection Surveillance (NNIS) score

    Time frame: Baseline

    Maximal value: 3; Minimal value: 0 (higher score indicates worse outcome)

Sponsors and collaborators

Lead sponsor

Oncology Institute of Vojvodina

Other Gov

Registry information

Official study title

Risk Factor Assessment for Surgical Site Infection After Colorectal Cancer Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Aug 5, 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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