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NCT Number: NCT02524925

Postoperative Stress Response in Patients Following Fast Track vs 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.

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Key information

Conditions

Hepatic Cancer Cancer of Pancreas Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

30 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fast track protocol

Procedure

Evaluation of postoperative stress

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Saint Savvas Anticancer Hospital

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 17, 2015
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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