- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01629992
Preoperative Counseling in Cholecystectomy
Preoperative Counseling in Cholecystectomy. A Randomized Trial
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
- Фаза 3
Контакты и местонахождение
Места учебы
-
-
Mato Grosso
-
Cuiaba, Mato Grosso, Бразилия, 78000-000
- Hospital Universitario Julio Mullar
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
Другие имена:
|
|
Без вмешательства: Control
The control group received no preoperative counseling either oral or written.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Visual analogue scale
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Episodes of vomiting
Временное ограничение: During the first 24h after surgery
|
Number of episodes of vomiting occurring until 24h after the operation
|
During the first 24h after surgery
|
Соавторы и исследователи
Следователи
- Главный следователь: Jose Aguilar-Nascimento, MD, PhD, Federal University of Mato Grosso
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- preopcounseling
- 697/CEP-HUJM/09 (Другой идентификатор: HUJM Research Ethics Committee)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .