Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316245
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-29
Brief Title:
Functional Capacity and Days Alive Out of Hospital at 30 Days
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
Evaluation of Days Alive and Out of Hospital at 30 Days in Patients With Poor or Good Functional Capacity Undergoing Gastrointestinal Surgery
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 582 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
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 582 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None