- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT06316245
Zdolność funkcjonalna i liczba dni przeżycia poza szpitalem po 30 dniach
Ocena liczby dni przeżytych i poza szpitalem po 30 dniach u pacjentów ze słabą lub dobrą sprawnością funkcjonalną poddawanych zabiegom chirurgicznym przewodu pokarmowego
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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-
Fatih
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Istanbul, Fatih, Turcja (Türkiye), 34093
- Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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.
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Days alive and out of hospital at 30 days (DAOH-30)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Days alive and out of hospital at 90 days (DAOH-90)
Ramy czasowe: 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
Ramy czasowe: 30 days
|
Cardiovascular, pulmonary, renal, neurologic, surgical, infectious and wound complications |
30 days
|
|
The Postoperative Morbidity Survey (POMS) defined morbidity
Ramy czasowe: 30 days
|
Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, hematological, wound complications and pain will be examined according to POMS |
30 days
|
|
Mortality
Ramy czasowe: 30 days and 90 days
|
In and out of hospital mortality |
30 days and 90 days
|
|
Intensive care unit (ICU) stay
Ramy czasowe: 30 days
|
Duration of ICU stay (days) |
30 days
|
|
Length of hospital stay after index surgery
Ramy czasowe: 30 days
|
Length of first hospital stay starting with index surgery (days) |
30 days
|
|
Rehospitalization
Ramy czasowe: 30 days and 90 days
|
Readmission and hospitalization after first discharge |
30 days and 90 days
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Muserref B Dincer, Istanbul University, Istanbul Medical Faculty, Department Anesthesiology and Reanimation
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 2024/178
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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