Clinical trial NCT06316245: Functional Capacity and Days Alive Out of Hospital at 30 Days
Official title: Evaluation of Days Alive and Out of Hospital at 30 Days in Patients With Poor or Good Functional Capacity Undergoing Gastrointestinal Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Surgery
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing gastrointestinal surgeries at Istanbul Medical Faculty in Istanbul-Turkey will be selected for the study population. Istanbul Medical Faculty is a tertiary center university hospital with approximately 25.000 surgeries annually.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Days alive and out of hospital at 30 days (DAOH-30)
timeFrame: 30 days
Secondary outcomes:
measure: Days alive and out of hospital at 90 days (DAOH-90)
timeFrame: 90 days
measure: Postoperative complications
timeFrame: 30 days
measure: The Postoperative Morbidity Survey (POMS) defined morbidity
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days and 90 days
measure: Intensive care unit (ICU) stay
timeFrame: 30 days
measure: Length of hospital stay after index surgery
timeFrame: 30 days
measure: Rehospitalization
timeFrame: 30 days and 90 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation
state: Fatih
Study officials:
affiliation: Istanbul University, Istanbul Medical Faculty, Department Anesthesiology and Reanimation
name: Muserref B Dincer
role: PRINCIPAL_INVESTIGATOR
References: