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临床试验/NCT07798544
NCT07798544已完成不适用

Preoperative Anaemia and Early Postoperative Morbidity According to the Clavien-Dindo Classification After Major Gastrointestinal Surgery: a Prospective Observational Cohort Study

University of Ioannina1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2025年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
1
主要终点
Any Early Postoperative Complication

研究概览

简要总结

This prospective observational cohort study evaluated the association between preoperative anaemia and early postoperative morbidity in adults undergoing major gastrointestinal surgery at the University Hospital of Ioannina, Greece. Consecutive patients undergoing elective or urgent open or laparoscopic gastrointestinal surgery were enrolled. Preoperative anaemia was defined as haemoglobin <13.0 g/dL in men and <12.0 g/dL in non-pregnant women. Patients were followed from surgery until hospital discharge or postoperative day 8, whichever occurred first. The primary outcome was any postoperative complication during this period. Secondary outcomes were major postoperative complications, defined as Clavien-Dindo grade III or higher, and discharge beyond the expected recovery period. The study also evaluated whether the association between preoperative anaemia and postoperative morbidity persisted after accounting for comorbidity, urgency of surgery, and surgical risk.

研究设计

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

入排标准

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

入选标准

  • Age >18 years
  • Ability to provide written informed consent
  • Undergoing major abdominal gastrointestinal surgery during the study period
  • Elective or urgent surgery
  • Open or laparoscopic surgical approach

排除标准

  • Emergency surgery
  • Organ transplantation

研究组 & 干预措施

Preoperative Anaemia

Participants with preoperative anaemia, defined as haemoglobin <13.0 g/dL in men and <12.0 g/dL in non-pregnant women before surgery. No study intervention was assigned.

No Preoperative Anaemia

Participants without preoperative anaemia, defined as haemoglobin ≥13.0 g/dL in men and ≥12.0 g/dL in non-pregnant women before surgery. No study intervention was assigned.

结局指标

主要结局

Any Early Postoperative Complication

时间窗: From the day of surgery through postoperative day 8 or until earlier hospital discharge

Occurrence of at least one postoperative complication recorded prospectively using a predefined list. Postoperative complications were graded according to the Clavien-Dindo classification.

次要结局

  • Major Postoperative Complication(From the day of surgery through postoperative day 8 or until earlier hospital discharge)
  • Number of Participants Remaining Hospitalized Beyond Postoperative Day 8(Postoperative day 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Agathi Karakosta

Assistant Professor of Anaesthesiology

University of Ioannina

研究点 (1)

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