Enhanced Recovery Protocols in Gynecologic Oncology (ERGO)

October 22, 2024 updated by: Nikolaos Thomakos, National and Kapodistrian University of Athens

Enhanced Recovery Protocols in Gynecological Cancer Patients: a Feasibility Study

Enhanced Recovery After Surgery (ERAS) are developed to provide a systematic structure for managing postsurgical patients.These protocols promote evidenced-based practices and implement a multidisciplinary effort to maintain normal physiology in the perioperative period and aid in earlier recovery. The present study aims to investigate the feasibility of and compliance to a structured ERAS protocol among Gynecological Oncological Centers in Greece as well as to compare the outcomes among patients that fullfilled the minimum number of necessary criteria, compared to those that were enrolled in ERAS protocols but did not meet the sufficient necessary criteria.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Enhanced Recovery After Surgery (ERAS) are developed to provide a systematic structure for managing postsurgical patients.These protocols promote evidenced-based practices and implement a multidisciplinary effort to maintain normal physiology in the perioperative period and aid in earlier recovery. ERAS protocols briefly include pre-admission education, pre-operative nutritional care, specific recommendations for pre-operative medications, a standardized anesthetic protocol, perioperative fluid management, multimodal analgesia (MMA), early mobilization, and early removal of urinary catheters.

ERGO study study aims to investigate the feasibility of and compliance to a structured ERAS protocol among Gynecological Oncological Centers in Greece as well as to compare the outcomes among patients that fullfilled the minimum number of necessary criteria, compared to those that were enrolled in ERAS protocols but did not meet the sufficient necessary criteria. Patients will be registered into the trial before surgery. Quality assurance program will be in place for both patients that will fulfill the ERAS criteria as well as for those that will not fulfill them.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece, 11523
        • Recruiting
        • First department of Obstetrics and Gynecology
        • Contact:
      • Larissa, Greece, 413 34
        • Recruiting
        • University of Thessaly
        • Contact:
      • Thessaloniki, Greece, 54642
        • Recruiting
        • Aristotle University of Thessaloniki, Second department of Obstetrics and Gynecology
        • Contact:
          • Stamatios Petousis, Assistant Professor
          • Phone Number: +30 6934050763
          • Email: petustam@auth.gr
      • Thessaloniki, Greece, 54642
        • Recruiting
        • Aristotle University of Thessaloniki, Third department of Obstetrics and Gynecology
        • Contact:
      • Thessaloniki, Greece, 56429
        • Recruiting
        • Aristotle University of Thesalloniki, Papageorgiou Hospiral
        • Contact:
          • Dimitrios Tsolakidis, Associate Professor
          • Phone Number: +30 2310 999 900
          • Email: dtgyn@auth.gr
    • Attica
      • Athens, Attica, Greece, 11522
        • Recruiting
        • Agios Savvas Anticancer Hospital
        • Contact:
      • Athens, Attica, Greece, 11528
        • Recruiting
        • First department of Obstetrics and Gynecology, National and Kapodistrian University of Athens
        • Contact:
        • Contact:
          • Vasilios Lygizos, MD
        • Contact:
          • Maria Fanaki, MD
        • Contact:
          • Filippos Ntailianas, MD
    • Piraeus
      • Athens, Piraeus, Greece, 18537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

In this study, patients that will be operated for gynecological cancer in the collaborating centers described in the Contacts and Locations section will be enrolled.

Description

Inclusion Criteria:

patients with gynaecological cancer and an ECOG performance status <4, ASA score <4.

Exclusion Criteria:

patients with metastatic cancer of non-gynaecological origin patients that are not able to follow ERAS protocol due to medical reasons patients with severe debilitating comorbidities (ECOG status 4, ASA score 4-5)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fulfilled ERAS criteria group
This group will include patients that achieved a compliance rate that exceeded 80% of the required predetermined criteria of ERAS protocols.
Combination product: ERAS group
This group will include patients that achieved a compliance rate that exceeded 80% of the required predetermined criteria of ERAS protocols.
Control group
This group will include patients that achieved a compliance rate that did not reach at least 80% of the required predetermined criteria of ERAS protocols.
Combination product: Control group
This group will include patients that do not follow the predetermined criteria of ERAS protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hospitalization
Time Frame: Up to 30 days postoperatively
From date of hospitalization until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months.
Up to 30 days postoperatively
Perioperative infections
Time Frame: Postoperatively (30 days)
Number of participants with postoperative infections (including surgical site, pulmonary and urinary tract infections)
Postoperatively (30 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rates
Time Frame: 3 years follow-up
Recurrent disease will be monitored through 3 year of follow up
3 years follow-up
Overall survival
Time Frame: 3 years follow-up
Overall survival of the patients will be measured through 3 year of follow up
3 years follow-up
Postoperative quality of life
Time Frame: Postoperatively (30 days)
Documentation of quality of life using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C40) and the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires. The EORTC-QLQ C30 involves 30 questions that are rated from 1 (no impact on quality of life) to 4 (debilitating symptoms). The FACT-G assesses physical, family, emotional and functional wellbeing through 27 questions that are scaled from 0 (no impact) to 4 (very much).
Postoperatively (30 days)
Postoperative morbidity (other than infectious) using the Clavien-Dindo classification
Time Frame: 30 days
Major events such as pulmonary embolism,accuse myocardial infarction,etc
30 days
Interval to adjuvant therapy
Time Frame: Up to 100 days
The interval between surgical treatment and adjuvant therapy (radiation and/or chemotherapytreatment) will be documented
Up to 100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Collaborators

Aristotle University Of Thessaloniki
University of Thessaly
Saint Savvas Anticancer Hospital
Metaxa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 131/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be provided upon reasonable request following communication with researchers

IPD Sharing Time Frame

Following study completion and up to 5 years from publication of findings.

IPD Sharing Access Criteria

Data will be provided through a dedicated de-identified redcap database

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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