Clinical trial NCT02524925: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Cancer
Cancer of Pancreas
Keywords: fast track surgery
eras program
hepatectomy
pancreatectomy
NPY
ACTH/Cortsiosol
postoperative stress
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Saint Savvas Anticancer Hospital
First posted: 2015-08-17
Enrollment: 231
Sex: ALL
Minimum age (years): 30
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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".

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

Primary outcomes:
measure: Analyzing Neuropeptide Y, Cortisol and Adrenocorticotropic hormones levels in blood samples
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 15 days
Secondary outcomes:
measure: Evaluating postoporative stress between the two protocols with scales
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 15 days
measure: Evaluating postoperative pain between the two protocols with scale
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 15 days
Other outcomes:
Locations:
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Evangelos A Konstantinou, RN, PhD
role: STUDY_DIRECTOR
References: