Hepatic CancerNCT02524925
Postoperative Stress Response in Patients Following Fast Track vs Conventional Protocol After Hepatectomy or Pancreatectomy
A study testing fast track protocol in people with Hepatic Cancer and Cancer of Pancreas, run by National and Kapodistrian University of Athens.
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. Read more about this study
- Who is it for?
- Ages 30 to 82 years
- Conditions the study is for
- Hepatic Cancer, Cancer of Pancreas
- What is being tested?
- fast track protocol
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with American Society of Anesthesiologists (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM I-III
- age 30-82 years,
- with normal level of consciousness and communication
Who cannot join
- the presence of chronic pain,
- kidney disease, neuropathy,
- systemic as well as chronic treatment with analgesics
About this study
Official title: Postoperative Stress Response in Patients Following Fast Track Versus 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.
Read the 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
- Being tested
- fast track protocol
- Keywords
- fast track surgery, eras program, hepatectomy, pancreatectomy, NPY, ACTH/Cortsiosol, postoperative stress
- Medical subject headings
- Liver Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fast track protocolProcedure or surgery
Evaluation of postoperative stress
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Measured: Participants will be followed for the duration of hospital stay, an expected average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startApr 2012
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CancerStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Savvas Anticancer Hospital
- Responsible party
- Principal investigator, Maria Kapritsou, National and Kapodistrian University of Athens
- Investigators
- Evangelos A Konstantinou, RN, PhD, Study director, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524925
- Sponsor's protocol ID
- 87
- Status last verified
- Aug 2015
- First submitted
- 10 Aug 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Stress Response in Patients Following Fast Track Versus Conventional Protocol After Hepatectomy or Pancreatectomy
- ClinicalTrials.gov ID
- NCT02524925
- Acronym / sponsor ID
- 87
- Conditions
- Hepatic Cancer, Cancer of Pancreas
- Keywords
- fast track surgery, eras program, hepatectomy, pancreatectomy, NPY, ACTH/Cortsiosol, postoperative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Saint Savvas Anticancer Hospital
- Study start
- Apr 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fast track protocol | Active comparator | Procedure: fast track protocolOral fluids intake (0.5 lt) 6 hours after operation Mobilization 4 hours after operation Check discharge criteria the 4th-6th postoperative day |
| conventional protocol | No intervention | –Oral intake after bowel mobilization Mobilization after the 1st postoperative day Check discharge criteria the 7th-15th postoperative day |
Who may qualify
- Ages
- 30 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with American Society of Anesthesiologists (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM I-III
- age 30-82 years,
- with normal level of consciousness and communication
Key exclusion criteria (3 listed)
- the presence of chronic pain,
- kidney disease, neuropathy,
- systemic as well as chronic treatment with analgesics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fast track protocolEvaluation of postoperative stress | Procedure or surgery | fast track protocol |
Primary outcome
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.
2 secondary outcomes
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangelos A Konstantinou, RN, PhD study director
National and Kapodistrian University of Athens
Questions about this trial
What is this clinical trial studying?
A study testing fast track protocol in people with Hepatic Cancer and Cancer of Pancreas, run by National and Kapodistrian University of Athens.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.