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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02524925
Enrollment
231
Registered
2015-08-17
Start date
2012-04-30
Completion date
2015-07-31
Last updated
2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Cancer, Cancer of Pancreas

Keywords

fast track surgery, eras program, hepatectomy, pancreatectomy, NPY, ACTH/Cortsiosol, postoperative stress

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.

Interventions

Evaluation of postoperative stress

Sponsors

Saint Savvas Anticancer Hospital
CollaboratorOTHER
National and Kapodistrian University of Athens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 82 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Analyzing Neuropeptide Y, Cortisol and Adrenocorticotropic hormones levels in blood samplesParticipants will be followed for the duration of hospital stay, an expected average of 15 daysAnalyzing 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

MeasureTime frameDescription
Evaluating postoporative stress between the two protocols with scalesParticipants will be followed for the duration of hospital stay, an expected average of 15 daysEvaluating 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 scaleParticipants will be followed for the duration of hospital stay, an expected average of 15 daysEvaluating postoperative pain between the two protocols with scale such as Puntillo scale the day of surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026