Postoperative Stress Response in Patients Following Fast Track vs Conventional Protocol After Hepatectomy or Pancreatectomy
- Conditions
- Hepatic CancerCancer of Pancreas
- Interventions
- Procedure: fast track protocol
- Registration Number
- NCT02524925
- Lead Sponsor
- National and Kapodistrian University of Athens
- Brief Summary
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.
- Detailed Description
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".
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 231
- patients with American Society of Anesthesiologists (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM I-III
- age 30-82 years,
- with normal level of consciousness and communication
- the presence of chronic pain,
- kidney disease, neuropathy,
- systemic as well as chronic treatment with analgesics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description fast track protocol fast track protocol Oral fluids intake (0.5 lt) 6 hours after operation Mobilization 4 hours after operation Check discharge criteria the 4th-6th postoperative day
- Primary Outcome Measures
Name Time Method Analyzing Neuropeptide Y, Cortisol and Adrenocorticotropic hormones levels in blood samples 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.
- Secondary Outcome Measures
Name Time Method 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 postoperative pain between the two protocols with scale such as Puntillo scale the day of surgery
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 Evaluating postoporative stress with scales, such as Zung scale the day of hospitalization, ICUESS scale the 3rd postoperative day, Puntillo scale the day of surgery and three self-experienced questions how sad are you feeling, how stressed are you feeling and how optimistic are you feeling in three phases:a. the day of hospitalzation, b. the day of surgery c. the day of discharge.