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Completed

NCT Number: NCT04696276

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Gynecologic Cancer Hysterectomy Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Savvas Anticancer Hospital

Athens, Attica, 11522, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Length of Hospital Stay (LOS)

    Time frame: up to 30 postoperative days

    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).

  2. Pain Levels

    Time frame: up to 3 postoperative days

    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.

  3. Number of Participants With the Ability to Getting up in a Chair Within 18h

    Time frame: within the first 18 postoperative hours

    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.

  4. Number of Participants With the Ability of Full Mobilization Within 18h Postoperatively

    Time frame: within the first 18 hours after the surgery

    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).

  5. Early Feeding

    Time frame: up to 6 hours postoperatively

    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.

Secondary outcomes

  1. Early Mobilization of the Digestive System

    Time frame: within 24 hours post surgery

    Number of participants who had their digestive system function on time, with hunger, bowel sounds and bowel movements within the first 24 hours postoperatively

  2. Early Discontinuation of IV Administration

    Time frame: within 24 h post surgery

    Number of participants who had early discontinuation of IV fluids and conversion to per os within 24 hours postoperatively

  3. Number of Participants Who Had Their Urinary Catheter Removal

    Time frame: within the first 24h after surgery

    Number of participants who had their urinary catheter removed within 24 hours postoperatively

  4. Number of Participants Who Had Their Drainage Removal Within 24h

    Time frame: within 24h post surgery

    Number of Participants who had their drainage removal within 24 hours postoperatively

  5. Blood Transfusion

    Time frame: within 48 hours post surgery

    Number of participants who had blood transfusion during their intraoperative and postoperative time

  6. Postoperative Complications

    Time frame: up to 5 postoperative days

    The evaluation of postoperative complications such as bleeding, thrombosis and inflammation.

  7. Readmission

    Time frame: up to 30 postoperative days

    Readmission rate by 30 days after discharge from the hospital

Sponsors and collaborators

Lead sponsor

University of West Attica

Other

Registry information

Acronym: ERAS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2021
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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