Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece

University of West Attica

Status: Completed

Conditions: Endometrial Cancer; Hysterectomy; Gynecologic Cancer; Ovarian Cancer

Treatments: Other: ERAS protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04696276

8/11-09-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: Female

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 2 patient groups

A-ERAS

Experimental group

Description:

will receive ERAS pathways care

Treatment:

Other: ERAS protocol

B-nonERAS

No Intervention group

Description:

will receive traditional non ERAS care