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临床试验/NCT07104903
NCT07104903已完成不适用

Risk Factor Assessment for Surgical Site Infection After Colorectal Cancer Surgery

Oncology Institute of Vojvodina1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Incidence of surgical site infection

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •Patients undergoing palliative surgical treatment of colorectal cancer

结局指标

主要结局

Incidence of surgical site infection

时间窗: During hospital stay (assessed up to 15 days)

Data collected from medical records and information system

次要结局

  • 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)

研究者

发起方
Oncology Institute of Vojvodina
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Nora Mihalek

Dr

Oncology Institute of Vojvodina

研究点 (1)

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