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

NCT ID: NCT02524925

Last Updated: 2015-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-07-31

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".

Conditions

Hepatic Cancer; Cancer of Pancreas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

fast track protocol

Intervention Type: PROCEDURE

Evaluation of postoperative stress

conventional protocol

Oral intake after bowel mobilization Mobilization after the 1st postoperative day Check discharge criteria the 7th-15th postoperative day

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

fast track protocol

Evaluation of postoperative stress

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Savvas Anticancer Hospital

OTHER

Sponsor Role: collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Maria Kapritsou

RN, BSc, MSc, PhD(c)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evangelos A Konstantinou, RN, PhD

Role: STUDY_DIRECTOR

National and Kapodistrian University of Athens

Other Identifiers

87

Identifier Type: -

Identifier Source: org_study_id