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

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ClinicalTrials.gov Identifier: NCT04696276
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
MARIA BOURAZANI, Saint Savvas Anticancer Hospital

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 gynecolodic 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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Hysterectomy Endometrial Cancer Gynecologic Cancer Other: ERAS protocol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Hospital leght of stay (LOS) [ Time Frame: up to 30 postoperative days ]
    Measuring how many days will stay in hospital for recovery. It is defined as the time frame from the day of operation to 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. As lower the number on pain scale as better the outcome.

  3. Hospital Complications [ Time Frame: up to 5 postoperative days ]
    The evaluation of postoperative complications such as bleeding, thrombosis and inflammation.

  4. Mobilization [ Time Frame: up to 3 postoperative days ]
    Mobilization time, which is defined as the time frame from the end of operation to the ability to walk without external assistance (unit: hours). Patient will performe a six-minutes-walk.


Secondary Outcome Measures :
  1. Depression-Stress- anxiety [ Time Frame: at baseline, the preoperation day, then one week after surgery and one month after surgery ]
    The evaluation of the presentation or not, of the patients 'depression, of the patients' emotional state (anxiety-depression) for their current state of health. Using HADS scale. Scores for each sub scale (depression and anxiety) are summed-up and range from 0-21. Values from 0-7 indicate normal levels, 8-10 are border values and from 11-21 are considered as pathologicals.

  2. Readmission [ Time Frame: up to 30 postoperative days ]
    Readmission rate by 30 days after discharge from the hospital



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04696276


Contacts
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Contact: MARIA BOURAZANI, PhDc 6955587809 ext +30 mbourazani@yahoo.com
Contact: Dimitrios Papatheodorou, PhD 6949100995 ext +30 papth@ath.forthnet.gr

Locations
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Greece
Saint Savvas Anticancer Hospital Recruiting
Athens, Attica, Greece, 11522
Contact: MARIA BOURAZANI, RN, PhDc    6955587809    mbourazani@yahoo.com   
Contact: Dimitrios Papatheodorou, MD, PhD    6949100995    papth@ath.forthnet.gr   
Sponsors and Collaborators
University of West Attica
Investigators
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Principal Investigator: MARIA BOURAZANI, PhDc Saint Savvas Anticancer Hospital
  Study Documents (Full-Text)

Documents provided by MARIA BOURAZANI, Saint Savvas Anticancer Hospital:
Additional Information:
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Responsible Party: MARIA BOURAZANI, Registered Nurse, PhD candidate, Saint Savvas Anticancer Hospital
ClinicalTrials.gov Identifier: NCT04696276    
Other Study ID Numbers: 8/11-09-2019
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MARIA BOURAZANI, Saint Savvas Anticancer Hospital:
gynecologic cancer
ERAS protocols
ERAS pathways
Gynecologic/oncology surgery
Additional relevant MeSH terms:
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Endometrial Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases