Functional Capacity and Days Alive Out of Hospital at 30 Days

NCT06316245 | Recruiting

• 1 other identifier: 2024/178
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Days alive and out of hospital at 90 days (DAOH-90)

  90 days

• Postoperative complications

  30 days

• The Postoperative Morbidity Survey (POMS) defined morbidity

  30 days

• Mortality

  30 days and 90 days

• Intensive care unit (ICU) stay

  30 days

Study Arms (2)

Group DASI ≤ 34

Patients with Duke Activity Status Index (DASI) scores are ≤ 34 before the surgery.

Other: DASI questionnaire

Group DASI > 34

Patients with Duke Activity Status Index (DASI) scores are \> 34 before the surgery.

Other: DASI questionnaire

Interventions

DASI questionnaire OTHER

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; Group DASI ≤ 34

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Study Officials

• Muserref B Dincer

  Istanbul University, Istanbul Medical Faculty, Department Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muserref B Dincer

CONTACT

+905321624712; mberildincer@gmail.com

Ahmet K Koltka

CONTACT

koltkak@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 18, 2024
• Study Start: March 19, 2024
• Primary Completion: June 19, 2025
• Study Completion: August 19, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)