Clinical trial NCT04696276: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Hysterectomy
Endometrial Cancer
Gynecologic Cancer
Keywords: gynecologic cancer
ERAS protocols
ERAS pathways
Gynecologic/oncology surgery
Lead sponsor: University of West Attica
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 gynecologic 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.

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

Primary outcomes:
measure: Length of Hospital Stay (LOS)
timeFrame: up to 30 postoperative days
measure: Pain Levels
timeFrame: up to 3 postoperative days
measure: Number of Participants With the Ability to Getting up in a Chair Within 18h
timeFrame: within the first 18 postoperative hours
measure: Number of Participants With the Ability of Full Mobilization Within 18h Postoperatively
timeFrame: within the first 18 hours after the surgery
measure: Early Feeding
timeFrame: up to 6 hours postoperatively
Secondary outcomes:
measure: Early Mobilization of the Digestive System
timeFrame: within 24 hours post surgery
measure: Early Discontinuation of IV Administration
timeFrame: within 24 h post surgery
measure: Number of Participants Who Had Their Urinary Catheter Removal
timeFrame: within the first 24h after surgery
measure: Number of Participants Who Had Their Drainage Removal Within 24h
timeFrame: within 24h post surgery
measure: Blood Transfusion
timeFrame: within 48 hours post surgery
measure: Postoperative Complications
timeFrame: up to 5 postoperative days
measure: Readmission
timeFrame: up to 30 postoperative days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Saint Savvas Anticancer Hospital
state: Attica
Study officials:
affiliation: Saint Savvas Anticancer Hospital
name: MARIA BOURAZANI, PhD
role: PRINCIPAL_INVESTIGATOR
References: