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

NCT04696276 | Completed Results

• 1 other identifier: 8/11-09-2019
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Hysterectomy; Endometrial Cancer; Gynecologic Cancer

Keywords

gynecologic cancer; ERAS protocols; ERAS pathways; Gynecologic/oncology surgery

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Early Mobilization of the Digestive System

  within 24 hours post surgery

• Early Discontinuation of IV Administration

  within 24 h post surgery

• Number of Participants Who Had Their Urinary Catheter Removal

  within the first 24h after surgery

• Number of Participants Who Had Their Drainage Removal Within 24h

  within 24h post surgery

• Blood Transfusion

  within 48 hours post surgery

Study Arms (2)

A-ERAS

EXPERIMENTAL

will receive ERAS pathways care

Other: ERAS protocol

B-nonERAS

NO INTERVENTION

will receive traditional non ERAS care

Interventions

ERAS protocol OTHER

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.

A-ERAS

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greek language speakers
• Have complete mental clarity
• Age \>18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of West Attica: lead

Study Sites (1)

Saint Savvas Anticancer Hospital

Athens, Attica, 11522, Greece

Location

Related Links

• Original Paper

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Limitations and Caveats

The limitations of the study could be the sample size (101 participants), but due to the COVID-19 pandemic where the annual number of surgeries was necessarily reduced, this number of participants is completely satisfactory.

Results Point of Contact

• Title: Maria Bourazani
• Organization: Saint Savvas Hospital of Athens

mbourazani@yahoo.com

+302106409000

Study Officials

• MARIA BOURAZANI, PhD

  Saint Savvas Anticancer Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse, PhD candidate

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: January 6, 2021
• Study Start: January 6, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Locations

GR (1)