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

NCT07104903 | Completed

• 1 other identifier: 4/24/3-5228/2-9
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Site Infections; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of surgical site infection

  Data collected from medical records and information system

  During hospital stay (assessed up to 15 days)

Secondary Outcomes (4)

• 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) score

  Baseline

• National Nosocomial Infection Surveillance (NNIS) score

  Baseline

Interventions

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.

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 03.06.2024. and 31.10.2024. in the Oncology Institute of Vojvodina.

You may qualify if:

• Adult patients (˃ 18 years of age)
• ASA III clinical 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

Location

MeSH Terms

Conditions

Surgical Wound Infection; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 5, 2025
• Study Start: December 19, 2024
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)