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临床试验/NCT06316245
NCT06316245招募中不适用

Evaluation of Days Alive and Out of Hospital at 30 Days in Patients With Poor or Good Functional Capacity Undergoing Gastrointestinal Surgery

Istanbul University1 个研究点 分布在 1 个国家目标入组 470 人开始时间: 2024年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
470
试验地点
1
主要终点
Days alive and out of hospital at 30 days (DAOH-30)

研究概览

简要总结

This prospective observational study aims to compare days alive and out of hospital at 30 days (DAOH-30) in patients with poor or good functional capacity undergoing gastrointestinal surgeries. The investigators are testing the hypothesis that patients with good functional capacity will have longer days alive and out of hospital than those with poor.

详细描述

Days Alive and Out of Hospital (DAOH) is a composite patient-centered outcome that integrates three critical clinical outcomes: death, hospital length of stay, and hospital readmission. It is associated with patient comorbidities, surgical complexity, and postoperative complications.

Evaluation of functional capacity before noncardiac surgery is recommended to identify the perioperative risks. Duke Activity Status Index (DASI) is one of the tools for determining functional capacity; the scores are between 0 and 58,2, and high scores are related to improved capacity. A DASI score of 34 and below was found to be a risk for moderate to severe complications and new disability.

The primary aim is to compare days alive and out of the hospital at 30 days in patients ≤ 34 and above 34 DASI scores. The secondary aims are to evaluate intensive care unit (ICU) need and duration, length of hospital stay, rehospitalization, postoperative complications, morbidity, and mortality in patients with DASI scores ≤ 34 and above 34. Days alive and out of hospital at 90 days will be compared in both groups as a secondary outcome. The investigators will also analyze the possible perioperative factors affecting the days alive and out of the hospital outcome.

Before the operation, the patients will answer the DASI questionnaire in the waiting area of the operating theatres. The patients will be divided into two groups according to the DASI score (Poor functional capacity: ≤ 34 points, good functional capacity: above 34 points).

Patient and surgical characteristics (comorbidities, American Society of Anesthesiologists physical status classification, laboratory values before the operation, frailty index value, American College of Surgeons Risk Calculator outcomes, surgery type, length of operation, intraoperative complications), ICU need and duration will be recorded. Postoperative complications ( cardiovascular, pulmonary, renal, neurologic, surgical, infectious, and wound ), the Postoperative Morbidity Survey (POMS) related morbidity and mortality on the 30th day will be investigated. Length of hospital stay starting with index surgery, rehospitalization and duration of further stays will be recorded. Days Alive and Out of Hospital at 30 days (DAOH-30) will be calculated using mortality, hospital length of stay, and readmissions between the date of the index surgery and the 30th postoperative day. 90th-day mortality and Days Alive and Out of Hospital at 90 days (DAOH-90) will also be investigated.

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

  • Patients undergoing intermediate and major upper or lower gastrointestinal surgeries (small intestine, colon, rectal, gastric, esophagus) with a predicted hospital stay of more than 24 hours
  • Patients aged 18 and above
  • Signed written informed consent
  • Reaching all perioperative data

排除标准

  • Day case/ambulatory or one overnight hospital stay for minor gastrointestinal and perianal surgeries (hernia repair, hemorrhoidectomy, perianal abscess and fistula, appendectomy)
  • Hepatobiliary surgeries (hepatectomy, pancreas and gallbladder surgeries)
  • Patients aged below 18
  • Not signed written informed consent
  • Missing perioperative data

结局指标

主要结局

Days alive and out of hospital at 30 days (DAOH-30)

时间窗: 30 days

It is calculated using mortality, hospital length of stay, and readmissions between the date of the index surgery and the 30th postoperative day.

次要结局

  • Postoperative complications(30 days)
  • The Postoperative Morbidity Survey (POMS) defined morbidity(30 days)
  • Days alive and out of hospital at 90 days (DAOH-90)(90 days)
  • Length of hospital stay after index surgery(30 days)
  • Mortality(30 days and 90 days)
  • Intensive care unit (ICU) stay(30 days)
  • Rehospitalization(30 days and 90 days)

研究者

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

Muserref Beril Dincer

Medical Doctor

Istanbul University

研究点 (1)

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