Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece
Phase: NA
Conditions: Ovarian Cancer, Hysterectomy, Endometrial Cancer, Gynecologic Cancer
Sponsor: University of West Attica

COVER LETTER  
 
 
Title: 
“Implementation of Enhanced Recovery After Surgery (ERAS) Pathways in 
Gynecologic Oncology” 
 
 
This research study was developed in the context of my dissertation. 
Its purpose is to study the benefit in women with gynecological cancer who undergo major 
gynecological surgeries, and follow a protocol of enhanced recovery after surgery 
compared to conventional postoperative care. 
The study is performed in a public oncology hospital in Greece, and is licensed by the 
scientific committee of the hospital, with the number 24111/16-10-2019. 
The Doctoral theses is approved by the scientific committee of the University of West 
Attica, Nursing Department, with no 8/11-09-2019.  
The implementation of ERAS programs is a topical issue in medical and nursing science 
worldwide. Especially in Greece, no similar programs have been studied in women with 
cancer of the internal genitalia undergoing MGOS, while such programs have been studied 
for major surgeries of the liver, pancreas, colorectal cancer, oesophagus and stomach. 
Last update of the study: 11-09-2019 
Uploaded the study to the PRS: 25-03-2025 
 
 

 
University of West Attica 
Nursing Department & 
Anticancer Oncology 
Hospital of Athens “Saint 
Savvas” 
 
 
 
 
 
DOCTORAL THESES 
 
 
Title: 
“Implementation of Enhanced Recovery After Surgery (ERAS) 
Pathways in Gynecologic Oncology” 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MARIA BOURAZANI, RN, MSc, PhDc 
 
Supervising Professor: Martha Kelesi 
 
 
 
 
 
ATHENS 2019 
 
 
 
 

 
 

Implementation of Enhanced Recovery After Surgery (ERAS) Pathways in 
Gynecologic Oncology 
 
Abstract 
 
Background 
Gynecological cancer is comprised of cancer of the female reproductive system, which 
includes the cervix, vulva, uterus, fallopian tubes, ovaries, and vagina [1]. The therapeutic 
approach to gynecological cancers involves surgical resection, with chemotherapy and/or 
radiation, and should always be scheduled and performed in specialized oncology centers 
[2] (European Society for Medical Oncology- ESMO, 2014). 
Major gynecological oncology surgeries (MGOS) cause moderate to severe postoperative 
pain and discomfort [3]. Patients undergoing MGOS need a multimodal approach to 
postoperative pain management, which provides great analgesic results with minimal side 
effects.   
Opioid regimens are commonly used in postoperative analgesia with often many side 
effects. In recent years, there has been a global effort to reduce the use of opioid regimens, 
in order to reduce their side effects (opioid-sparing multimodal analgesia).  
Various alternative postoperative pain approaches have been studied that reduce the need 
for high doses of opioids postoperatively, such as the use of coxib and gabapentin (Alayed 
et al., 2014). 
The last decade, the need to reduce the hospital stay (LOS) and the hospital cost have 
been developed new pathways of fast track surgeries, known as Enhanced Recovery after 
Surgery (ERAS) protocols. ERAS pathways have been reported to promote earlier 
recovery and be beneficial for patients. 
ERAS pathways involve evidenced based approaches in three phases: preoperative, 
intraoperative and postoperative, by an interdisciplinary team including surgeon, 
anesthesiologist and perioperative nurse. The combination of these techniques reduces the 
postoperative stress response, relieves acute postoperative pain, promotes early feeding and 
mobilization, thus reducing LOS and hospitalization cost and increasing patient 
satisfaction (Barber & Van, 2015). 
 
Aim 
The hypothesis of this theses was if the ERAS pathway could reduce the length of stay 
(LOS) in hospital for patients undergoing MGOS. The study aims to compare the 
effectiveness of ERAS protocol and the conventional non-ERAS clinical practice of 
recovery, of patients who will undergo MGOS. 
 
Objectives 
The objectives of the present study comparatively in the two groups are: 
1. Hospital leght of stay (LOS) 
Measuring how many days will stay in hospital for recovery. It is defined as the time 
frame from the day of operation to discharge from the hospital (unit: days) 
2. Pain levels 
Evaluation of analgesia and correlation of requirements with opioid analgesics; by 
recording of postoperative pain levels and the evaluation of the effectiveness of analgesic 

treatment of patients. Using Numbered Pain Scale. As lower the number on pain scale as 
better the outcome. 
3. Hospital Complications 
The evaluation of postoperative complications such as bleeding, thrombosis and 
inflammation.  
4. Mobilization 
Mobilization time, which is defined as the time frame from the end of operation to the 
ability to walk without external assistance (unit: hours). Patients will perform a 6 minutes 
walking test. 
5. Depression-Stress- anxiety 
The evaluation of the presentation or not, of the patients 'depression, of the patients' 
emotional state (anxiety-depression) for their current state of health. Using HADS scale. 
Scores for each sub scale (depression and anxiety) are summed-up and range from 0-21. 
Values from 0-7 indicate normal levels, 8-10 are border values and from 11-21 are 
considered as pathologicals. 
6. Readmission rate by 30 days after discharge of the hospital. 
 
Method 
This is a randomized study. 
The study will be carried out at a General Oncology Hospital of Athens. 
Study population: The study sample will include patients with gynecological cancer who 
undergo tumor resection surgery, and they will be randomly divided into two groups.  
Group A will include patients who will follow the ERAS protocol, and the group B will 
include patients who will follow conventional postoperative care. 
Randomization: Based on the results of the pilot research, a power analysis will be 
performed and the final number of the sample with the hypotheses with a significance 
level of 0.05 will be determined. 
Next, the total number of n patients in the study sample will be randomly divided into 
two groups in the two intervention categories A (ERAS) and B (Classical) with a fixed 
number of individuals each. 
Data analysis: 
The processing and statistical analysis of the data will be done using the software package 
IBM SPSS 21.0 (Statistical Package for Social Sciences). The level of statistical 
significance (value a), in all statistical tests, will be equal to 0.05. Thus, a value of p <0.05 
will be considered statistically significant. The statistical analysis will include the 
following (Galanis 2015): 
(a) Univariate analysis. Frequency distributions of the variables to study the values of 
each variable separately and independently of the others. The continuous variables will 
be expressed as mean (standard deviation), while the nominal variables as absolute (n) 
and relative frequencies (%). 
(b) Variable analysis. Appropriate statistical controls will be used depending on the type 
and distribution of variables, such as e.g. the x2 (chi-square test), the t (student's t-test), 
the analysis of variance, the Pearson correlation coefficient, the Spearman correlation 
coefficient etc. 
(c) Multivariate analysis. Multivariate linear and logistic regression models will be 
implemented to neutralize confusers. 

Research tools: The numerical scale of pain will be used to assess the intensity of pain 
(Sarakatsianou, 2012). 
The HADS scale (Michopoulos et al., 2008) will be used to assess patients' emotional 
state and is designed to assist in the assessment of anxiety and depression in patients in 
general hospitals. 
For the collection of medical parameters, data will be collected from the anesthesia charts, 
the surgery minutes, the patient's personal file, the protocol data and from interviews with 
patients. 
 
Inclusion Criteria: 
Greek language speakers 
Have complete mental clarity 
Age >18 years 
 
Exclusion Criteria: 
Refusal to sign consent 
Patients receiving treatment for chronic pain 
Patients receiving antipsychotic therapy, Psychopathy 
They have acute or chronic kidney and / or liver disease 
History or family history of malignant hyperthermia 
Known allergy to propofol, desflurane, or any other anesthetic agent 
Impairment of cognitive function or communication 
History of postoperative delirium 
 
 
ERAS PROTOCOL 
 
Post-operation day 
 
Informed conset 
Informing the patient 
about the ERAS program 
Surgical plan - Targeting  
Intestinal preparation with 
fleet-enema 
Thromboprophylaxis 
Cleaning bath 
 
 
 
 
 
 
Elastic anticoagulant socks 
Clexane 20-40mg SC daily 
Intraoperatively 
Normothermia 
parecoxib 40mg IV 
paracetamol 1000mg IV 
Morfine 0,1mg/kg 
Magnesium  
 
Operation day, Day-0 
liquids PO after 4-6 h  
PONV 
mobilization after 4 h  
diuresis <30 ml/h 
 
Paracetamol 1000mg 
 
ondansetron 4mgX2  
Metoclopramide 10mgX3  
 
 
 

parecoxib 40mg  
Morfine 0,1mg/kg 
 
Diet clear fluids and jelly 
 
 
 
Water, coffee, apple juice, 
tea 
Day 1 
Mobilization out of the 
room 
Incentive spirometer 
Thromboprophylaxis 
diuresis <30 ml/h 
Intestinal function 
Cleaning bath 
Light Diet 1 
Oxycodone / paracetamol 
(Depalgos) PO q: 4-6 prn 
Lornoxicam 8mgX2 
Removal of drains 
 
 
 
 
<30 ml/h 
Emollients or Senna 
 
 
Diet 1: Soup, jelly, puree, 
boiled chicken 
Day 2 & 3 
Full diet 
Full mobilization 
Incentive Spirometer 
Thromboprophylaxis 
Diuresis 
Intestinal function 
Cleaning bath 
Oxycodone / paracetamol 
(Depalgos) PO q: 4-6 prn 
Lornoxicam 8mgX2 
 
Emollients or Senna 
Discharge criteria 
Full diet 
Full mobilization 
Help at home 
Great analgesia 
management 
Understanding the 
instructions  
 
 
 
 
 
 
 
Discharge instructions 
Thromboprophylaxis 
Normal functionality of 
the digestive system 
Oxycodone / paracetamol 
(Depalgos) PO q: 4-6 prn 
 
 
Follow-up 
Contact via phone 
Appointment for 
reassessment 
 

 
NON-ERAS PATHWAYS 
Post-operation day 
Intestinal preparation with 
fleet-enema 
Thromboprophylaxis 
Cleaning bath 
 
 
Elastic anticoagulant socks 
Clexane 20-40mg SC daily 
Intraoperatively 
Normothermia 
parecoxib 40mg IV 
paracetamol 1000mg IV 
Morfine 0,1mg/kg 
 
Day 0  
On nausea ondansetron 
4mg X2 
Mobilization at will 
Diuresis 30ml/h 
Paracetamol 1000mgX4 
Tramadol 50mgX4 or 
Morphine 0.1mg / kg 
Parenteral fluid IV 2-3Lt / 
24h 
NPO 
 
 
 
 
 
Day 1 
Mobilization at will 
Thromboprophylaxis 
Diuresis 
Intestinal function 
Cleaning bath 
Diet: hydrated and jelly 
Paracetamol 1000mgX4 
Tramadol 10mg/kgX4 
 
 
 
 
 
Day 2 until Discharge day 
Mobilization 
Thromboprophylaxis 
Diuresis <30 ml/h 
Intestinal function 
Cleaning bath 
Paracetamol 1000mgX4 
Tramadol 50-100mgX4 
Removal of drains 
 
 
 
emollients 
Discharge criteria 
Full diet 
Full mobilization 
Help at home 
Great analgesia 
management 
Understanding the 
instructions 
 
 
 
 
 
Discharge instructions 
Thromboprophylaxis 
 

Follow-up 
After 15 days from the 
surgery 
 
 
Ethics 
The researcher undertakes to follow the national and international principles of research 
ethics. The anonymity and confidentiality of the data collected will also be ensured and 
will not be made known at any stage of the study. 
The patient who want to take part in the research will fill in the consent form for her 
participation in the study, after being informed about the aims of the research (informed 
consent). 
The study will be conducted in accordance with the Declaration of Helsinki and with the 
approval of the Scientific Committee of the Hospital and Ethics Committee of the Nursing 
Department of University of West Attica. 
The participation in the research will be optional and anonymous and it will not be possible 
to identify the participants. Therefore, there is no risk to the safety of patients, and the 
health care they have received is not affected. 
 
Expected results from the research 
The present research is expected to assess the contribution of enhanced recovery after 
surgery programs and their benefits to both the patient individually and the health system 
in general. The importance of these programs is expected to emerge in the days of 
hospitalization, in postoperative pain, in perioperative stress and in the mobilization of 
patients who will have undergone major gynecologic oncological surgeries. In addition, 
conclusions will be drawn about the quality of life of women with gynecological cancer 
that will help health professionals understand the needs of these patients and their care. 
While, from the study of the complications and the estimation of the financial health 
expenses, for the patients with gynecological oncological problem who will undergo 
surgical treatment, it is expected that future measures will be taken to reduce and prevent 
the complications but also to minimize the health care expenses. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
CONSENT FOR PARTICIPATION IN RESEARCH STUDY 
 
Title: "Implementation of Enhanced Recovery After Surgery (ERAS) Pathways in 
Gynecologic Oncology". 
Purpose: To investigate the effectiveness of the ERAS pathways on postoperative 
recovery in patients undergoing major gynecological oncology surgery. 
Consent: 
 Name: ............................................................................... Age………………………………….  
I understand that the results of the research can be used in the future in conference 
announcements and / or publications in scientific journals. The research data will not be 
disclosed to anyone other than the researcher. 
 All research data that will be used in conference announcements and / or publications in 
scientific journals, will remain anonymous and I should not be identifiable. 
I understand that my participation is voluntary and I am not required to answer all 
questions. I can withdraw from the study at any time, even after the signing of this 
statement, without giving an explanation or the reason for my withdrawal, without 
affecting the level of service to me, and with the obligation to destroy the data. 
The researcher will keep the research data until the completion of the project, for a period 
of 5 years and then they will be destroyed. The data will be destroyed in accordance with 
the regulations of the Personal Data Protection Authority. 
The procedure as well as the intended results of the research have been explained to me 
by the researcher. 
I understand that any of my information about this research will be anonymous and I will 
not be identifiable. 
I confirm that I read and understood the Patient Information Form today __ / __ / __ and 
that I had the opportunity to ask questions. 

I have read the above information and agree to participate in the research. 
 
Sign………………………………………………………………..Date…………………………………………..