- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01629992
Preoperative Counseling in Cholecystectomy
Preoperative Counseling in Cholecystectomy. A Randomized Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
This was a randomized, single-blinded, clinical study carried out at the Julio Muller University Hospital (Mato Grosso State, Brazil). This study was conducted according to the guidelines laid down in the Declaration of Helsinki and all procedures involving human subjects/patients were approved by the hospital Research Ethics Committee registered under number 697/CEP-HUJM/09. Written informed consent was obtained from all patients.
Except for the preoperative counseling which was received only by the intervention group, all patients received the same protocol of perioperative care.
The main endpoint of the study was the presence and the intensity of postoperative symptoms such as nausea, vomiting and pain. A questionnaire containing a visual analogue scale (VAS) was applied 24h after the operation to measure the intensity of postoperative pain, nausea and the well-being. The VAS consisted of a horizontal line, 100 mm in length, anchored by word descriptors at each end to represent the lowest and the highest intensity of all the symptoms analyzed. The patient was asked to mark in the straight line the point that most likely represents the symptom at the moment. The VAS score of each individual was determined by measuring in millimeters from the left end of the line to the point marked. The questions were: "how severe was your pain during this period of 24h after the operation?", "how severe was the intensity of your nausea during this period of 24h after the operation? ", and "how great is your well-being at the present moment". For the first two questions the words at each end of the line were "no pain" and "severe pain", and "no nausea" and "severe nausea". For the well-being question the words were "no well-being" and "greatest well-being". The Vomiting was also recorded as a categorical variable (yes or no). The length of stay and postoperative complications were also collected.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Mato Grosso
-
Cuiaba, Mato Grosso, Brazylia, 78000-000
- Hospital Universitario Julio Mullar
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- adult age (18-65 years-old),
- both sexes and
- candidates for an elective open cholecystectomy
Exclusion Criteria:
- having diabetes mellitus,
- chronic kidney failure,
- chronic liver disease,
- serum bilirubin > 2 mg/dL,
- body mass index (BMI) > 35 kg/m2,
- American Anesthesiologists Association (ASA) score > 3,
- gastro-esophageal reflux,
- gastroparesis or intestinal obstruction.
Patients with any non-compliance with the study protocol, who had the choledochus opened or associated operations, who experienced severe intraoperative complications (any type of shock, cardiac arrest or coagulations problems) or experienced prolonged (> 4 h) operative time were also excluded.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: Preoperative counseling
The intervention group received preoperative counseling by both orally and written.
A written leaflet containing information was provided to each patient of this group.
|
The intervention group received preoperative counseling by both orally and written.
A written leaflet containing information was provided to each patient of this group.
Inne nazwy:
|
Brak interwencji: Control
The control group received no preoperative counseling either oral or written.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Visual analogue scale
Ramy czasowe: 24h after operation
|
A questionnaire containing a visual analogue scale (VAS) was applied 24h after the operation to measure the intensity of postoperative pain, nausea and the well-being.
The VAS consisted of a horizontal line, 100 mm in length, anchored by word descriptors at each end to represent the lowest and the highest intensity of all the symptoms analyzed.
The patient was asked to mark in the straight line the point that most likely represents the symptom at the moment.
The VAS score of each individual was determined by measuring in millimeters from the left end of the line to the point marked.
|
24h after operation
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Episodes of vomiting
Ramy czasowe: During the first 24h after surgery
|
Number of episodes of vomiting occurring until 24h after the operation
|
During the first 24h after surgery
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Jose Aguilar-Nascimento, MD, PhD, Federal University of Mato Grosso
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- preopcounseling
- 697/CEP-HUJM/09 (Inny identyfikator: HUJM Research Ethics Committee)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .