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

Sponsor

National and Kapodistrian University of Athens (Other)

Overall Status

Completed

CT.gov ID

NCT02524925

Collaborator

Saint Savvas Anticancer Hospital (Other)

231

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Cancer Cancer of Pancreas	Procedure: fast track protocol	N/A

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 ",

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 Design

Study Type:

Interventional

Actual Enrollment :

231 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 82 Years

Sexes Eligible for Study:

All

Accepts 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