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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Surgery
• Intervention / Treatment: Other: DASI questionnaire

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.

• Study Type: Observational
• Enrollment (Estimated): 470

Contacts and Locations

• Study Contact: Name: Muserref B Dincer; Phone Number: +905321624712; Email: mberildincer@gmail.com
• Study Contact Backup: Name: Ahmet K Koltka; Email: koltkak@yahoo.com

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Recruiting
      • Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation
      • Contact: Muserref B Dincer; Phone Number: +905321624712; Email: mberildincer@gmail.com
      • Principal Investigator: Muserref B Dincer
      • Contact: Ahmet K Koltka; Email: koltkak@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group DASI ≤ 34; Patients with Duke Activity Status Index (DASI) scores are ≤ 34 before the surgery.	Other: DASI questionnaire; 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.
Group DASI > 34; Patients with Duke Activity Status Index (DASI) scores are > 34 before the surgery.	Other: DASI questionnaire; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days alive and out of hospital at 30 days (DAOH-30)	It is calculated using mortality, hospital length of stay, and readmissions between the date of the index surgery and the 30th postoperative day.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days alive and out of hospital at 90 days (DAOH-90)	It is calculated using mortality, hospital length of stay, and readmissions between the date of the index surgery and the 90th postoperative day.	90 days
Postoperative complications	Cardiovascular, pulmonary, renal, neurologic, surgical, infectious and wound complications	30 days
The Postoperative Morbidity Survey (POMS) defined morbidity	Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, hematological, wound complications and pain will be examined according to POMS	30 days
Mortality	In and out of hospital mortality	30 days and 90 days
Intensive care unit (ICU) stay	Duration of ICU stay (days)	30 days
Length of hospital stay after index surgery	Length of first hospital stay starting with index surgery (days)	30 days
Rehospitalization	Readmission and hospitalization after first discharge	30 days and 90 days

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Muserref B Dincer, Istanbul University, Istanbul Medical Faculty, Department Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): June 19, 2025
• Study Completion (Estimated): August 19, 2025

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024/178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No