跳至主要内容
临床试验/NCT04744376
NCT04744376Unknown不适用

Predictive Value of Quality of Recovery - 15 Questionnaire for Morbidity in Major Abdominal Surgery

Mehmet Ali Koç8 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
8
主要终点
Predictive value of QoR - 15 on postoperative complications

研究概览

简要总结

Surgical operations and recovery after anesthesia is a complex process. Studies examining the interventions performed in the preoperative period often focus on classical clinical outcomes such as postoperative organ dysfunction, morbidity or complications. Postoperative recovery of the patient is rarely considered the most important outcome variable in interventional studies.

In this study, the Quality of recovery 15 (QoR - 15) questionnaire that measures the recovery score, and the American college of surgeons surgical risk calculator have been used to compare the predictive values of patient's preoperative condition on postoperative recovery period and possible morbidity and mortality.

详细描述

Surgical operations and recovery after anesthesia is a complex process. Studies examining the interventions performed in the preoperative period often focus on classical clinical outcomes such as postoperative organ dysfunction, morbidity or complications. Postoperative recovery of the patient is rarely considered the most important outcome variable in interventional studies. In this study, the effects of both preoperative patient condition and postoperative recovery on morbidity and mortality are investigated.

In order to evaluate the ability of QoR - 15 to predict postoperative complications patients who underwent major abdominal surgery, patients answer the Quality of Recovery 15 questionnaire both in the preoperative and postoperative periods.

In addition, the risk of postoperative complications is calculated in the preoperative period with the American college of surgeons (ACS) surgical risk calculator.

Finally, postoperative complications of all patients are recorded according to Clavien Dindo classification.

The primary goal is to understand the predictive value of the QOR15 score on postoperative complications. Secondarily, it is to compare of predictive values of QoR15 with ACS risk calculator on morbidity and mortality. Another secondary aim is to investigate the effect of preoperative conditions of patients on postoperative recovery.

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 the patients who undergone major GIS surgery

排除标准

  • Patients who has an expected mortality in six months because of the primary disease
  • Patients who received parenteral nutrition before surgery
  • Patients who has a previous major abdominal surgery
  • Patients who do not accept the surgery
  • Patients with a disability who require a nursing care

结局指标

主要结局

Predictive value of QoR - 15 on postoperative complications

时间窗: postoperative day 30

QoR - 15 questionnaire is a measurement tool that evaluates the recovery quality of patients after surgery and anesthesia by the patient himself (patient reported outcome measure - PROM). However it has a potential to predict postoperative complication risk. Preoperative and postoperative scores of QoR - 15 will be evaluated for a cut-off value regarding postoperative complications which is recorded according to Clavien Dindo classification.

次要结局

  • Quality of Recovery(postoperative day 30)
  • Reliability of QoR - 15 on postoperative complications(In the preoperative period)

研究者

发起方
Mehmet Ali Koç
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mehmet Ali Koç

MD

Ankara University

研究点 (8)

Loading locations...

相似试验