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临床试验/NCT04774354
NCT04774354已完成不适用

Prospective Assessment of Surgical Risk Using the POSSUM, P-POSSUM, Clinical Frailty Scale and Charlson's Comorbidity Index in Abdominal Surgery.

Ángel Becerra-Bolaños, MD PhD2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2021年3月1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
350
试验地点
2
主要终点
Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery at the Doctor Negrín University Hospital of Gran Canaria

研究概览

简要总结

Abdominal surgery represents the most frequent activity in the surgical block. Advances in surgical techniques and improvements in postoperative care imply the need for greater control of the surgical outcomes obtained and the comparison of results between services with the same characteristics with the help of assessment scales.

A prospective observational study will be carried out during 2021. All patients undergoing abdominal surgery will be included. Demographic variables, personal and surgical history, preoperative and intraoperative data, and variables related to surgery will be collected. At 30 days postoperatively, the clinical history of the patients will be reviewed and postoperative complications will be collected as well as the mortality that occurred. With these data, the POSSUM, the P-POSSUM, the Clinical Frailty Scale and the Charlson comorbidity index will be calculated.

详细描述

Abdominal surgery represents the most frequent activity in the surgical block. Advances in surgical techniques and improvements in postoperative care imply the need for greater control of the surgical outcomes obtained and the comparison of results between services with the same characteristics with the help of assessment scales.

A prospective observational study will be carried out during 2021. All patients undergoing abdominal surgery will be included. Demographic variables, personal and surgical history, preoperative and intraoperative data, and variables related to surgery will be collected. At 30 days postoperatively, the clinical history of the patients will be reviewed and postoperative complications will be collected as well as the mortality that occurred. With these data, the POSSUM, the P-POSSUM and the Charlson comorbidity index will be calculated.

Once this data are collected, the following objectives will be met:

  • Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery in our hospital, comparing the estimated morbidity and mortality with that observed 30 days after surgery.
  • Analyze the correlation of estimated morbidity and mortality of the POSSUM and P-POSSUM with respect to that observed in scheduled surgery vs. emergencies.
  • Analyze the correlation of estimated morbidity and mortality of POSSUM and P-POSSUM with respect to that observed in laparoscopic surgery vs. laparotomy
  • Establish the relationship and predictive ability of Clinical Frailty Scale and Charlson Comorbidity Index with respect to morbidity and mortality at 30

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

入选标准

  • All patients undergoing scheduled or urgent intervention for gastrointestinal surgery will be included in the study.

排除标准

  • Patients operated under locoregional anesthesia.
  • Patients undergoing Major Ambulatory Surgery (CMA) regardless of postoperative destination (home or hospitalization floor).
  • Patients intervened on a scheduled basis in the afternoon shift
  • Patients who require surgery after the first 24 hours of hospital admission

结局指标

主要结局

Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery at the Doctor Negrín University Hospital of Gran Canaria

时间窗: 30 days after surgery.

To compare the estimated morbidity and mortality with that observed.

Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery

时间窗: 30 days after surgery.

To compare the estimated morbidity and mortality with that observed.

次要结局

  • Analyze the correlation of estimated morbidity and mortality of the POSSUM and P-POSSUM with respect to that observed in scheduled surgery vs. emergencies.(30 days after surgery.)
  • Analyze the correlation of estimated morbidity and mortality of POSSUM and P-POSSUM with respect to that observed in laparoscopic surgery vs. laparotomy(30 days after surgery.)

研究者

发起方
Ángel Becerra-Bolaños, MD PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ángel Becerra-Bolaños, MD PhD

Principal Investigator

Hospital Universitario de Gran Canaria Doctor Negrín

研究点 (2)

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