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

Primary Purpose

Hepatic Cancer, Cancer of Pancreas

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fast track protocol
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hepatic Cancer focused on measuring fast track surgery, eras program, hepatectomy, pancreatectomy, NPY, ACTH/Cortsiosol, postoperative stress

Eligibility Criteria

30 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    fast track protocol

    conventional protocol

    Arm Description

    Oral fluids intake (0.5 lt) 6 hours after operation Mobilization 4 hours after operation Check discharge criteria the 4th-6th postoperative day

    Oral intake after bowel mobilization Mobilization after the 1st postoperative day Check discharge criteria the 7th-15th postoperative day

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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

    Full Information

    First Posted
    August 10, 2015
    Last Updated
    August 14, 2015
    Sponsor
    National and Kapodistrian University of Athens
    Collaborators
    Saint Savvas Anticancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02524925
    Brief Title
    Postoperative Stress Response in Patients Following Fast Track vs Conventional Protocol After Hepatectomy or Pancreatectomy
    Official Title
    Postoperative Stress Response in Patients Following Fast Track Versus Conventional Protocol After Hepatectomy or Pancreatectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National and Kapodistrian University of Athens
    Collaborators
    Saint Savvas Anticancer Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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".

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatic Cancer, Cancer of Pancreas
    Keywords
    fast track surgery, eras program, hepatectomy, pancreatectomy, NPY, ACTH/Cortsiosol, postoperative stress

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    231 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    fast track protocol
    Arm Type
    Active Comparator
    Arm Description
    Oral fluids intake (0.5 lt) 6 hours after operation Mobilization 4 hours after operation Check discharge criteria the 4th-6th postoperative day
    Arm Title
    conventional protocol
    Arm Type
    No Intervention
    Arm Description
    Oral intake after bowel mobilization Mobilization after the 1st postoperative day Check discharge criteria the 7th-15th postoperative day
    Intervention Type
    Procedure
    Intervention Name(s)
    fast track protocol
    Intervention Description
    Evaluation of postoperative stress
    Primary Outcome Measure Information:
    Title
    Analyzing Neuropeptide Y, Cortisol and Adrenocorticotropic hormones levels in blood samples
    Description
    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.
    Time Frame
    Participants will be followed for the duration of hospital stay, an expected average of 15 days
    Secondary Outcome Measure Information:
    Title
    Evaluating postoporative stress between the two protocols with scales
    Description
    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.
    Time Frame
    Participants will be followed for the duration of hospital stay, an expected average of 15 days
    Title
    Evaluating postoperative pain between the two protocols with scale
    Description
    Evaluating postoperative pain between the two protocols with scale such as Puntillo scale the day of surgery
    Time Frame
    Participants will be followed for the duration of hospital stay, an expected average of 15 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    82 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Evangelos A Konstantinou, RN, PhD
    Organizational Affiliation
    National and Kapodistrian University of Athens
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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