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临床试验/NCT01629992
NCT01629992已完成2 期

Preoperative Counseling in Cholecystectomy. A Randomized Trial

Federal University of Mato Grosso2 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
119
试验地点
2
主要终点
Visual analogue scale

研究概览

简要总结

The investigators examined whether a written plus verbal preoperative counseling for patients undergoing open cholecystectomy would improve perioperative symptoms such as nausea, vomiting and pain.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult age (18-65 years-old),
  • both sexes and
  • candidates for an elective open cholecystectomy

排除标准

  • 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.

结局指标

主要结局

Visual analogue scale

时间窗: 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.

次要结局

  • Episodes of vomiting(During the first 24h after surgery)

研究者

发起方
Federal University of Mato Grosso
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Eduardo de Aguilar-Nascimento

Chairman Professor

Federal University of Mato Grosso

研究点 (2)

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