Ovarian CancerERASNCT04696276

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

A study testing ERAS protocol in people with Ovarian Cancer and Hysterectomy, run by University of West Attica at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 79 years, women only
Conditions the study is for: Ovarian Cancer, Hysterectomy, Endometrial Cancer
What is being tested?: ERAS protocol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 1 siteGreece
Study dates: 6 Jan 2020to 31 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Greek language speakers
Have complete mental clarity
Age >18 years

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

Saint Savvas Anticancer Hospital
Athens, Attica, 11522

Other trials in Greece

About this study

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.

Read the 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.

Conditions: Ovarian Cancer, Hysterectomy, Endometrial Cancer, Gynecologic Cancer
Being tested: ERAS protocol
Keywords: gynecologic cancer, ERAS protocols, ERAS pathways, Gynecologic/oncology surgery
Medical subject headings: Ovarian Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ERAS protocolOther
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.

Study groups in NCT04696276
Study group	Role	What they receive
A-ERAS	Experimental	will receive ERAS pathways care Receives: Other: ERAS protocol
B-nonERAS	No intervention	will receive traditional non ERAS care

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: up to 6 hours postoperatively

Secondary outcomes (7)

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
Measured: 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
Measured: 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
Measured: 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
Measured: within 24h post surgery
Blood Transfusion
Number of participants who had blood transfusion during their intraoperative and postoperative time
Measured: within 48 hours post surgery
Postoperative Complications
The evaluation of postoperative complications such as bleeding, thrombosis and inflammation.
Measured: up to 5 postoperative days
Readmission
Readmission rate by 30 days after discharge from the hospital
Measured: up to 30 postoperative days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 202031 Dec 2023

First posted6 Jan 2021
Study start6 Jan 2020
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ovarian CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04696276
Sponsor's protocol ID: 8/11-09-2019
Acronym: ERAS
Status last verified: Mar 2025
First submitted: 8 Nov 2020
Last updated: 26 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ovarian Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece
ClinicalTrials.gov ID: NCT04696276
Acronym / sponsor ID: ERAS / 8/11-09-2019
Conditions: Ovarian Cancer, Hysterectomy, Endometrial Cancer, Gynecologic Cancer
Keywords: gynecologic cancer, ERAS protocols, ERAS pathways, Gynecologic/oncology surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: University of West AtticaUniversity, hospital or other
Study start: 6 Jan 2020 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 6 Jan 2021 (actual)
Results: Posted 26 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
A-ERAS	Experimental	Other: ERAS protocolwill receive ERAS pathways care
B-nonERAS	No intervention	–will receive traditional non ERAS care

Who may qualify

Ages: 18 to 79 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Greek language speakers
Have complete mental clarity
Age >18 years

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ERAS protocolspecial 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.	Other	A-ERAS

Primary outcome

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).
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.
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.
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).
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.

7 secondary outcomes

Early Mobilization of the Digestive System
Time frame: within 24 hours post surgery
Early Discontinuation of IV Administration
Time frame: within 24 h post surgery
Number of Participants Who Had Their Urinary Catheter Removal
Time frame: within the first 24h after surgery
Number of Participants Who Had Their Drainage Removal Within 24h
Time frame: within 24h post surgery
Blood Transfusion
Time frame: within 48 hours post surgery
Postoperative Complications
Time frame: up to 5 postoperative days
Readmission
Time frame: up to 30 postoperative days

Results and safety

Results posted to the registry on 26 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A-ERAS	51	51
B-Non ERAS	50	50

Primary outcome: Length of Hospital Stay (LOS)

Time frame: up to 30 postoperative days. Mean (Inter-Quartile Range). Unit: days

Measure	LOS in ERAS Group n = 51	LOS in Non-ERAS Group n = 50
Value	3.8 (2 to 10)	5.9 (3 to 10)

Primary outcome: Pain Levels

Time frame: up to 3 postoperative days. Mean (Standard Deviation). Unit: units on a scale

Measure	Postoperative Pain Levels in ERAS Group n = 51	Postoperative Pain Levels in Non-ERAS Group n = 50
Value	3.6 (1)	4.6 (1.2)

Primary outcome: Number of Participants With the Ability to Getting up in a Chair Within 18h

Time frame: within the first 18 postoperative hours. Count of participants. Unit: Participants

Measure	Sitting -up on a Chair for Participants in ERAS Group n = 49	Sitting-up on a Chair for Participants in Non-ERAS Group n = 49
Value	46	5

Primary outcome: Number of Participants With the Ability of Full Mobilization Within 18h Postoperatively

Time frame: within the first 18 hours after the surgery. Count of participants. Unit: Participants

Measure	Standing-up in the Room for Participants in ERAS Group n = 50	Standing-up in the Room for Participants in Non-ERAS Group n = 49
Value	48	9

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Initial 30 postoperative days following surgical intevention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Number of Adverse Events in ERAS Group	0 of 51 (0%)	0 of 51 (0%)	0 of 51
Number of Adverse Events in Non-ERAS Group	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Original PaperLink provided by the sponsor.

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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MARIA BOURAZANI, PhD principal investigator

Saint Savvas Anticancer Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ERAS protocol in people with Ovarian Cancer and Hysterectomy, run by University of West Attica at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Hospital Stay (LOS) (time frame: up to 30 postoperative days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04696276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.