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Gastrointestinal SurgeryNCT06316245

Functional Capacity and Days Alive Out of Hospital at 30 Days

An observational study of Gastrointestinal Surgery, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Surgery
What is being tested?
DASI questionnaire
How many people
490 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Mar 2024to 19 Dec 2025
How long will I take part?
90 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation

    Istanbul, Fatih, 34093

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
DASI questionnaire

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DASI questionnaireOther

    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.

Study groups in NCT06316245
Study groupRoleWhat they receive
Group DASI ≤ 34Patients with Duke Activity Status Index (DASI) scores are ≤ 34 before the surgery.
Receives: Other: DASI questionnaire
Group DASI > 34Patients with Duke Activity Status Index (DASI) scores are > 34 before the surgery.
Receives: Other: DASI questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days

Secondary outcomes (7)
  1. 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.

    Measured: 90 days

  2. Postoperative complications

    Cardiovascular, pulmonary, renal, neurologic, surgical, infectious and wound complications

    Measured: 30 days

  3. The Postoperative Morbidity Survey (POMS) defined morbidity

    Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, hematological, wound complications and pain will be examined according to POMS

    Measured: 30 days

  4. Mortality

    In and out of hospital mortality

    Measured: 30 days and 90 days

  5. Intensive care unit (ICU) stay

    Duration of ICU stay (days)

    Measured: 30 days

  6. Length of hospital stay after index surgery

    Length of first hospital stay starting with index surgery (days)

    Measured: 30 days

  7. Rehospitalization

    Readmission and hospitalization after first discharge

    Measured: 30 days and 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start19 Mar 2024
  3. Primary completion19 Oct 2025
  4. Study completion19 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
490 participants (actual)
Target duration
90 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316245
Sponsor's protocol ID
2024/178
Status last verified
Nov 2026
First submitted
29 Feb 2024
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gastrointestinal Surgery, run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days alive and out of hospital at 30 days (DAOH-30) (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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