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

NCT02524925 | Completed DMC

• 1 other identifier: 87
• Study Type: interventional
• Target: 231
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatic Cancer; Cancer of Pancreas

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Evaluating postoporative stress between the two protocols with scales

  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

  Participants will be followed for the duration of hospital stay, an expected average of 15 days

Study Arms (2)

fast track protocol

ACTIVE COMPARATOR

Oral fluids intake (0.5 lt) 6 hours after operation Mobilization 4 hours after operation Check discharge criteria the 4th-6th postoperative day

Procedure: fast track protocol

conventional protocol

NO INTERVENTION

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

Interventions

fast track protocol PROCEDURE

Evaluation of postoperative stress

fast track protocol

Eligibility Criteria

• Age: 30 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with American Society of Anesthesiologists (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM I-III
• age 30-82 years,
• with normal level of consciousness and communication

You may not qualify if:

• the presence of chronic pain,
• kidney disease, neuropathy,
• systemic as well as chronic treatment with analgesics

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Saint Savvas Anticancer Hospital: collaborator

MeSH Terms

Conditions

Liver Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Evangelos A Konstantinou, RN, PhD

  National and Kapodistrian University of Athens

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, BSc, MSc, PhD(c)

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 17, 2015
• Study Start: April 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 17, 2015

Record last verified: 2015-08