Postoperative Stress Response in Patients Following Fast Track vs Conventional Protocol After Hepatectomy or Pancreatectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Postoperative Stress Response in Patients Following Fast Track Versus Conventional Protocol After Hepatectomy or Pancreatectomy

Conditions
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Hepatic Cancer, Cancer of Pancreas

Intervention / Treatment
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* Procedure: fast track protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with American Society of Anesthesiologists (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM I-III age 30-82 years, with normal level of consciousness and communication Exclusion Criteria: the presence of chronic pain, kidney disease, neuropathy, systemic as well as chronic treatment with analgesics

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fast track protocol<br>Oral fluids intake (0.5 lt) 6 hours after operation Mobilization 4 hours after operation Check discharge criteria the 4th-6th postoperative day | Procedure: fast track protocol<br>* Evaluation of postoperative stress<br>|
| No Intervention: conventional protocol<br>Oral intake after bowel mobilization Mobilization after the 1st postoperative day Check discharge criteria the 7th-15th postoperative day | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyzing Neuropeptide Y, Cortisol and Adrenocorticotropic hormones levels in blood samples | 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. | Participants will be followed for the duration of hospital stay, an expected average of 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating postoporative stress between the two protocols with scales | 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. | 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 | Evaluating postoperative pain between the two protocols with scale such as Puntillo scale the day of surgery | Participants will be followed for the duration of hospital stay, an expected average of 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fast track surgery, eras program, hepatectomy, pancreatectomy, NPY, ACTH/Cortsiosol, postoperative stress