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

Cancer of Pancreas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524925
• Other study ID #: 87
• Status: Completed
• Phase: N/A
• First received: August 10, 2015
• Last updated: August 14, 2015
• Start date: April 2012
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 82 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer of Pancreas
• Hepatic Cancer
• Liver Neoplasms
• Pancreatic Neoplasms

Intervention

Procedure:
• fast track protocol
Evaluation of postoperative stress

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens	Saint Savvas Anticancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analyzing Neuropeptide Y, Cortisol and Adrenocorticotropic hormones levels in blood samples	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	Yes
Secondary	Evaluating postoporative stress between the two protocols with scales	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	Yes
Secondary	Evaluating postoperative pain between the two protocols with scale	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	Yes