跳至主要内容
临床试验/NCT07249333
NCT07249333招募中不适用

Effect of Neoadjuvant Radiotherapy on the Incidence of Perioperative Complications After Radical Surgical Treatment of Colorectal Cancer

Oncology Institute of Vojvodina1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Incidence of particular perioperative complications (surgical site infection, urinary infection, wound dehiscence, bowel anastomosis dehiscence, ileus, reoperation)

研究概览

简要总结

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.

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 (over 18 years of age)
  • •Clinical Frailty Scale 2, 3 or 4 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 particular perioperative complications (surgical site infection, urinary infection, wound dehiscence, bowel anastomosis dehiscence, ileus, reoperation)

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

Data collected from medical records and information system

次要结局

  • Length of hospital stay(During hospital stay (assessed up to 15 days))
  • ClassIntra classification of intraoperative adverse events(Perioperative/Periprocedural)
  • Clavien-Dindo classification of postoperative adverse events(During hospital stay (assessed up to 15 days))
  • HARM (Hospital stay, Readmission, Mortality) scale of postoperative adverse events(During hospital stay (assessed up to 15 days))
  • Length of intensive care unit stay(During hospital stay (assessed up to 15 days))
  • Duration of antibiotic use (Days of Therapy - DOT)(During hospital stay (assessed up to 15 days))

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

Asist. Dr.

Oncology Institute of Vojvodina

研究点 (1)

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