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Funksjonell kapasitet og dager i live utenfor sykehus etter 30 dager

2. november 2026 oppdatert av: Muserref Beril Dincer, Istanbul University

Evaluering av dager i live og utenfor sykehus etter 30 dager hos pasienter med dårlig eller god funksjonsevne som gjennomgår gastrointestinal kirurgi

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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

490

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Fatih
      • Istanbul, Fatih, Tyrkia (Türkiye), 34093
        • Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Group DASI ≤ 34

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

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.

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Days alive and out of hospital at 30 days (DAOH-30)
Tidsramme: 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.

30 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Days alive and out of hospital at 90 days (DAOH-90)
Tidsramme: 90 days

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
Tidsramme: 30 days

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

30 days
The Postoperative Morbidity Survey (POMS) defined morbidity
Tidsramme: 30 days

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

30 days
Mortality
Tidsramme: 30 days and 90 days

In and out of hospital mortality

30 days and 90 days
Intensive care unit (ICU) stay
Tidsramme: 30 days

Duration of ICU stay (days)

30 days
Length of hospital stay after index surgery
Tidsramme: 30 days

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

30 days
Rehospitalization
Tidsramme: 30 days and 90 days

Readmission and hospitalization after first discharge

30 days and 90 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Muserref B Dincer, Istanbul University, Istanbul Medical Faculty, Department Anesthesiology and Reanimation

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. mars 2024

Primær fullføring (Faktiske)

19. oktober 2025

Studiet fullført (Faktiske)

19. desember 2025

Datoer for studieregistrering

Først innsendt

29. februar 2024

Først innsendt som oppfylte QC-kriteriene

11. mars 2024

Først lagt ut (Faktiske)

18. mars 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2024/178

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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