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).
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
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.
- Conditions
- Gastrointestinal Surgery
- 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 group | Role | What they receive |
|---|---|---|
| Group DASI ≤ 34 | Patients with Duke Activity Status Index (DASI) scores are ≤ 34 before the surgery. Receives: Other: DASI questionnaire | |
| Group DASI > 34 | Patients 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.
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)
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
Postoperative complications
Cardiovascular, pulmonary, renal, neurologic, surgical, infectious and wound complications
Measured: 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
Measured: 30 days
Mortality
In and out of hospital mortality
Measured: 30 days and 90 days
Intensive care unit (ICU) stay
Duration of ICU stay (days)
Measured: 30 days
Length of hospital stay after index surgery
Length of first hospital stay starting with index surgery (days)
Measured: 30 days
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.
- First posted18 Mar 2024
- Study start19 Mar 2024
- Primary completion19 Oct 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SurgeryStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muserref Beril Dincer, Istanbul University
- Investigators
- Muserref B Dincer, Principal investigator, Istanbul University, Istanbul Medical Faculty, Department Anesthesiology and Reanimation
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Days Alive and Out of Hospital at 30 Days in Patients With Poor or Good Functional Capacity Undergoing Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT06316245
- Acronym / sponsor ID
- 2024/178
- Conditions
- Gastrointestinal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 19 Oct 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group DASI ≤ 34 | – | Other: DASI questionnairePatients with Duke Activity Status Index (DASI) scores are ≤ 34 before the surgery. |
| Group DASI > 34 | – | Other: DASI questionnairePatients with Duke Activity Status Index (DASI) scores are > 34 before the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASI questionnaireAll 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. | Other | Group DASI > 34, Group DASI ≤ 34 |
Primary outcome
Days alive and out of hospital at 30 days (DAOH-30)
Time frame: 30 days
It is calculated using mortality, hospital length of stay, and readmissions between the date of the index surgery and the 30th postoperative day.
7 secondary outcomes
Days alive and out of hospital at 90 days (DAOH-90)
Time frame: 90 days
Postoperative complications
Time frame: 30 days
The Postoperative Morbidity Survey (POMS) defined morbidity
Time frame: 30 days
Mortality
Time frame: 30 days and 90 days
Intensive care unit (ICU) stay
Time frame: 30 days
Length of hospital stay after index surgery
Time frame: 30 days
Rehospitalization
Time frame: 30 days and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muserref B Dincer principal investigator
Istanbul University, Istanbul Medical Faculty, Department Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
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.