Preoperative Counseling in Cholecystectomy
Preoperative Counseling in Cholecystectomy. A Randomized Trial
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Mato Grosso
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Cuiaba、Mato Grosso、巴西、78000-000
- Hospital Universitario Julio Mullar
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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.
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The intervention group received preoperative counseling by both orally and written.
A written leaflet containing information was provided to each patient of this group.
其他名称:
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无干预:Control
The control group received no preoperative counseling either oral or written.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Visual analogue scale
大体时间:24h after operation
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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.
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24h after operation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Episodes of vomiting
大体时间:During the first 24h after surgery
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Number of episodes of vomiting occurring until 24h after the operation
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During the first 24h after surgery
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合作者和调查者
调查人员
- 首席研究员:Jose Aguilar-Nascimento, MD, PhD、Federal University of Mato Grosso
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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