Brief Title
Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece
Official Title
Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece
Brief Summary
The Enhanced Recovery After Surgery (ERAS) program includes preoperative counseling, fasting
avoidance, non-opioid analgesia, fluid balance, normothermia and early mobilization. ERAS
pathways were developed to reduce hospital length of stay, reduce costs and decrease
perioperative opioid requirements, and be beneficial for patients. We propose the hypothesis
that the ERAS pathway could reduce the length of stay (LOS) in hospital for patients
undergoing major gynecolodic oncology surgery (MGOS).
Patients were randomly allocated in two groups: An ERAS pathway group including preoperative
counseling, early feeding/mobilization, and opioid-sparing multimodal analgesia; and a
classic model group of post operative recovery as control.
Detailed Description
The Gynecological Cancer of the inner genital organs includes ovarian cancer, endometrial and
cervical cancer and its therapeutic approach is surgical removal of the organ with cancer.
The last decade has developed various postoperative recovery protocols aimed at safe and
rapid recovery of the patient after a surgery and early discharge from the hospital. These
protocols are known as ERAS (Enhanced Recovery After Surgery) protocols or Fast-Track (FT)
and combine various evidence-based perioperative care techniques.
The ERAS protocols include specific approaches preoperative, intraoperative and
postoperative, by the multidisciplinary team (surgeon, anesthetist and nurse), and aim at
reducing the postoperative stress and pain, fasten the feeding and the mobilization of the
patient after the surgery and rapid the hospital discharge.
This trial is designed to evaluate the superiority of the ERAS pathway to conventional
non-ERAS clinical practice in reducing the LOS. The results may provide new insight into the
clinical applications of the ERAS pathway for MGOS.
This doctoral thesis aims to compare the effectiveness of the Protocol ERAS against the
classical model of recovery, in the postoperative recovery of patients with Gynecological
Cancer undergoing MGOS, in a Public Oncology Hospital in Greece.
The importance of ERAS programs is expected to emerge in the length of hospital stay, in pain
control, in perioperative stress, in the early feeding and mobilization of patients who have
undergone MGOS.
Study Type
Interventional
Primary Outcome
Hospital leght of stay (LOS)
Secondary Outcome
Depression-Stress- anxiety
Condition
Ovarian Cancer
Intervention
ERAS protocol
Study Arms / Comparison Groups
A-ERAS
Description: will receive ERAS pathways care
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
120
Start Date
January 6, 2020
Completion Date
December 30, 2021
Primary Completion Date
July 31, 2021
Eligibility Criteria
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
Gender
Female
Ages
18 Years - 79 Years
Accepts Healthy Volunteers
No
Contacts
MARIA BOURAZANI, PhDc, 6955587809, [email protected]
Location Countries
Greece
Location Countries
Greece
Administrative Informations
NCT ID
NCT04696276
Organization ID
8/11-09-2019
Responsible Party
Principal Investigator
Study Sponsor
University of West Attica
Study Sponsor
MARIA BOURAZANI, PhDc, Principal Investigator, Saint Savvas Anticancer Hospital
Verification Date
January 2021