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Functional Capacity and Days Alive Out of Hospital at 30 Days

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06316245
Enrollment
470
Registered
2024-03-18
Start date
2024-03-19
Completion date
2025-08-19
Last updated
2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Surgery

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.

Interventions

All patients will answer the DASI questionnaire before surgery. According to their scores, they will be divided into two groups. A score of 34 and below will be considered poor, and above 34 will be considered to have good functional capacity.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Days alive and out of hospital at 30 days (DAOH-30)30 daysIt is calculated using mortality, hospital length of stay, and readmissions between the date of the index surgery and the 30th postoperative day.

Secondary

MeasureTime frameDescription
Days alive and out of hospital at 90 days (DAOH-90)90 daysIt is calculated using mortality, hospital length of stay, and readmissions between the date of the index surgery and the 90th postoperative day.
The Postoperative Morbidity Survey (POMS) defined morbidity30 daysPulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, hematological, wound complications and pain will be examined according to POMS
Mortality30 days and 90 daysIn and out of hospital mortality
Postoperative complications30 daysCardiovascular, pulmonary, renal, neurologic, surgical, infectious and wound complications
Length of hospital stay after index surgery30 daysLength of first hospital stay starting with index surgery (days)
Rehospitalization30 days and 90 daysReadmission and hospitalization after first discharge
Intensive care unit (ICU) stay30 daysDuration of ICU stay (days)

Countries

Turkey (Türkiye)

Contacts

Primary ContactMuserref B Dincer
mberildincer@gmail.com+905321624712
Backup ContactAhmet K Koltka
koltkak@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026