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

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Ovarian Cancer; Endometrial Cancer; Hysterectomy
• Intervention / Treatment: Other: ERAS protocol

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
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11522
      • Saint Savvas Anticancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A-ERAS; will receive ERAS pathways care	Other: ERAS protocol; special approaches in three phases preoperatively, intraoperatively and postoperatively, by an interdisciplinary team comprising of the surgeon, the anesthesiologist and the nurse. The combination of these techniques reduces the reaction to postoperative stress, relieves acute postoperative pain, restores the patient immediately to their original feeding and mobilization habits, thus reducing the time required for their complete recovery.
No Intervention: B-nonERAS; will receive traditional non ERAS care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay (LOS)	Measuring how many days the participants will stay in hospital for the post-op recovery. It is defined as the time frame from the day of the surgery to the day of discharge from the hospital (unit: days).	up to 30 postoperative days
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, from 0 that means no pain at all, to 10 that means the worst pain. As lower the number on pain scale as better the outcome.	up to 3 postoperative days
Number of Participants With the Ability to Getting up in a Chair Within 18h	The number of participants who had the ability to have a sit steadily on a chair himself, within the first 18 hours after the surgery.	within the first 18 postoperative hours
Number of Participants With the Ability of Full Mobilization Within 18h Postoperatively	The participants should be able to stand on their feet, walk in the room, go to the toilet and make a short walk in the surgical ward within the first 18 hours after the surgery. Mobilization time, which is defined as the time frame from the end of the operation until they are able to walk without external assistance (unit: hours).	within the first 18 hours after the surgery
Early Feeding	Feeding within the first 6 hours after the surgery. The participants should be able to drink clear fluids (water, tea,chamomile, apple juice, filter coffee, jelo) with or without sweeteners, given that they don't have PONV.	up to 6 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission	Readmission rate by 30 days after discharge from the hospital	up to 30 postoperative days
Early Mobilization of the Digestive System	Number of participants who had their digestive system function on time, with hunger, bowel sounds and bowel movements within the first 24 hours postoperatively	within 24 hours post surgery
Early Discontinuation of IV Administration	Number of participants who had early discontinuation of IV fluids and conversion to per os within 24 hours postoperatively	within 24 h post surgery
Number of Participants Who Had Their Urinary Catheter Removal	Number of participants who had their urinary catheter removed within 24 hours postoperatively	within the first 24h after surgery
Number of Participants Who Had Their Drainage Removal Within 24h	Number of Participants who had their drainage removal within 24 hours postoperatively	within 24h post surgery
Blood Transfusion	Number of participants who had blood transfusion during their intraoperative and postoperative time	within 48 hours post surgery
Postoperative Complications	The evaluation of postoperative complications such as bleeding, thrombosis and inflammation.	up to 5 postoperative days

Collaborators and Investigators

• Sponsor: University of West Attica
• Investigators: Principal Investigator: MARIA BOURAZANI, PhD, Saint Savvas Anticancer Hospital

Publications and helpful links

Helpful Links

• Original Paper

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 8, 2020
• First Submitted That Met QC Criteria: January 3, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: gynecologic cancer; ERAS protocols; ERAS pathways; Gynecologic/oncology surgery
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: 8/11-09-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No