Postoperative Stress Response in Patients Following Fast Track Versus Conventional Protocol After Hepatectomy or Pancreatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 主要终点
- Analyzing Neuropeptide Y, Cortisol and Adrenocorticotropic hormones levels in blood samples
研究概览
简要总结
A prospective randomized clinical study, with cross-sectional comparisons and correlations was conducted from May 2012 to July 2015 with a sample of 231 patients who have undergone hepatectomy or pancreatectomy, randomized into 2 groups. In group A was applied postoperatively the protocol Fast-track, while in group B the conventional postoperative care. Demographic and clinical data were collected. In 170 patients, Neuropeptide Y (NPY), Adrenocorticotropic hormone (ACTH)/Cortisol plasma levels were measured by ELISA method: a) at the day of patient's admission, b) the operation day, c) the 3rd postoperative day or prior to discharge.
详细描述
Pain levels were assessed by Puntillo scale (behavioral observation scale) which has ranges; 0-1 "no pain", 2-4 "aching" 5-7 "moderate pain" 8-10 and "severe pain".
Patient stress levels were evaluated by: a) scale I.C.U.E.S.S. which evaluated environmental stress during their stay in hospital and takes values; 40-80 "no environmental stress" 81-120 "mild to moderate environmental stress," 121-160 " Moderate to severe environmental stress ", b) three questions of self- experienced feelings (with a score of 0 = None and 10 = Completely) like "How sad you feel right now?" "How stress do you feel right now?" "How optimist do you feel right now about the future?" The data collected in three phases: a) the day of hospitalization, b) the day of surgery, and c) the third postoperative day or before discharge.
Depression levels were evaluated with Zung scale (Zung self-rating depression scale), which assesses depression levels with a score 25-49 for "normal level mood," 50-59 for "mild depression", 60-69 for "moderate depression" and 70 + for "severe depression".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with American Society of Anesthesiologists (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM I-III
- •age 30-82 years,
- •with normal level of consciousness and communication
排除标准
- •the presence of chronic pain,
- •kidney disease, neuropathy,
- •systemic as well as chronic treatment with analgesics
结局指标
主要结局
Analyzing Neuropeptide Y, Cortisol and Adrenocorticotropic hormones levels in blood samples
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 15 days
Analyzing Neuropeptide Y, Cortisol and Adrenocorticotropic hormones levels in blood samples in patients after hepatectomy or pancreatectomy. These measures will occured in three phases a. the day of hospitalzation, b. the day of surgery c. the day of discharge.
次要结局
- Evaluating postoperative pain between the two protocols with scale(Participants will be followed for the duration of hospital stay, an expected average of 15 days)
- Evaluating postoporative stress between the two protocols with scales(Participants will be followed for the duration of hospital stay, an expected average of 15 days)
研究者
Maria Kapritsou
RN, BSc, MSc, PhD(c)
National and Kapodistrian University of Athens