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

August 14, 2015 updated by: Maria Kapritsou, National and Kapodistrian University of Athens

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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".

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Procedure: fast track protocol
Evaluation of postoperative stress
No Intervention: conventional protocol
Oral intake after bowel mobilization Mobilization after the 1st postoperative day Check discharge criteria the 7th-15th postoperative day

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Collaborators

Saint Savvas Anticancer Hospital

Investigators

  • Study Director: Evangelos A Konstantinou, RN, PhD, National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 17, 2015

Study Record Updates

Last Update Posted (Estimate)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 14, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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