- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2012-04
2015-03
2015-07
231
NCT02524925
National and Kapodistrian University of Athens
National and Kapodistrian University of Athens
INTERVENTIONAL
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.
Pain levels were assessed by Puntillo scale (behavioral observation scale) which has ranges; 0-1 "no pain", 2-4 ⊬hing" 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".
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-08-10 | N/A | 2015-08-14 |
2015-08-14 | N/A | 2015-08-17 |
2015-08-17 | N/A | 2015-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: 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 | PROCEDURE: fast track protocol
|
| NO_INTERVENTION: conventional protocol Oral intake after bowel mobilization Mobilization after the 1st postoperative day Check discharge criteria the 7th-15th postoperative day |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
30 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
