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
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
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
NCT ID
NCT02524925
First Posted
August 10, 2015
Last Updated
August 14, 2015
Sponsor
National and Kapodistrian University of Athens
Collaborators
Saint Savvas Anticancer Hospital
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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