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

Primary Purpose

Ovarian Cancer, Hysterectomy, Endometrial Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
ERAS protocol
Sponsored by
University of West Attica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ovarian Cancer focused on measuring gynecologic cancer, ERAS protocols, ERAS pathways, Gynecologic/oncology surgery

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Saint Savvas Anticancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A-ERAS

B-nonERAS

Arm Description

will receive ERAS pathways care

will receive traditional non ERAS care

Outcomes

Primary Outcome Measures

Hospital leght of stay (LOS)
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).
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. As lower the number on pain scale as better the outcome.
Hospital Complications
The evaluation of postoperative complications such as bleeding, thrombosis and inflammation.
Mobilization
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

Depression-Stress- anxiety
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.
Readmission
Readmission rate by 30 days after discharge from the hospital

Full Information

First Posted
November 8, 2020
Last Updated
January 3, 2021
Sponsor
University of West Attica
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1. Study Identification

Unique Protocol Identification Number
NCT04696276
Brief Title
Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece
Acronym
ERAS
Official Title
Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of West Attica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Hysterectomy, Endometrial Cancer, Gynecologic Cancer
Keywords
gynecologic cancer, ERAS protocols, ERAS pathways, Gynecologic/oncology surgery

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A-ERAS
Arm Type
Experimental
Arm Description
will receive ERAS pathways care
Arm Title
B-nonERAS
Arm Type
No Intervention
Arm Description
will receive traditional non ERAS care
Intervention Type
Other
Intervention Name(s)
ERAS protocol
Intervention Description
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 Outcome Measure Information:
Title
Hospital leght of stay (LOS)
Description
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).
Time Frame
up to 30 postoperative days
Title
Pain levels
Description
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.
Time Frame
up to 3 postoperative days
Title
Hospital Complications
Description
The evaluation of postoperative complications such as bleeding, thrombosis and inflammation.
Time Frame
up to 5 postoperative days
Title
Mobilization
Description
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.
Time Frame
up to 3 postoperative days
Secondary Outcome Measure Information:
Title
Depression-Stress- anxiety
Description
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.
Time Frame
at baseline, the preoperation day, then one week after surgery and one month after surgery
Title
Readmission
Description
Readmission rate by 30 days after discharge from the hospital
Time Frame
up to 30 postoperative days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARIA BOURAZANI, PhDc
Phone
6955587809
Ext
+30
Email
mbourazani@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitrios Papatheodorou, PhD
Phone
6949100995
Ext
+30
Email
papth@ath.forthnet.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIA BOURAZANI, PhDc
Organizational Affiliation
Saint Savvas Anticancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Savvas Anticancer Hospital
City
Athens
State/Province
Attica
ZIP/Postal Code
11522
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARIA BOURAZANI, RN, PhDc
Phone
6955587809
Email
mbourazani@yahoo.com
First Name & Middle Initial & Last Name & Degree
Dimitrios Papatheodorou, MD, PhD
Phone
6949100995
Email
papth@ath.forthnet.gr

12. IPD Sharing Statement

Links:
URL
http://dx.doi.org/10.1136/ijgc-2019-ESGO.1138
Description
ePoster

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

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