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ERASERGONCT06655506

Enhanced Recovery Protocols in Gynecologic Oncology

An observational study of ERAS and Gynecologic Cancer, run by National and Kapodistrian University of Athens at 8 sites in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 25 to 85 years, women only
What is being tested?
ERAS group
How many people
600 participants
Where
8 sitesGreece
Study dates
20 Oct 2024to 30 Jul 2026
How long will I take part?
60 Days
Phase
Observational
Are there results?
None posted in the registry

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 25 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

8 sites in 1 country.

Nikolaos Thomakos, MD, PhD contact

+302132162291

thomakir@hotmail.com

Vasilios Pergialiotis, MD, PhD, MSc contact

+302132162291

pergialiotis@yahoo.com

8 sites in 1 country

Greece8 sites, 8 recruiting

  • First department of Obstetrics and Gynecology

    Athens, Athens, 11523

    Vasilios Pergialiotis, MD, +306947326459, pergialiotis@yahoo.com

    Recruiting

  • Agios Savvas Anticancer Hospital

    Athens, Attica, 11522

    Dimitrios Papatheodorou, MD, PhD, 2106409408 ext. +30, gynecology1@agsavvas-hosp.gr

    Recruiting

  • First department of Obstetrics and Gynecology, National and Kapodistrian University of Athens

    Athens, Attica, 11528

    Vasilios Pergialiotis, Assistant Professor, +306947326459, pergialiotis@yahoo.com

    Vasilios Lygizos, MD

    Recruiting

  • Metaxa Anticancer Hospital

    Athens, Piraeus, 18537

    Georgios Vorgias, MD, PhD, gyn@metaxa-hospital.gov.gr

    Not yet recruiting

  • University of Thessaly

    Larissa, Larissa, 413 34

    Alexandros Daponte, Professor, 2411115654 ext. +30, dapontea@otenet.gr

    Recruiting

  • Aristotle University of Thessaloniki, Second department of Obstetrics and Gynecology

    Thessaloniki, Thessaloniki, 54642

    Stamatios Petousis, Assistant Professor, 6934050763 ext. +30, petustam@auth.gr

    Recruiting

  • Aristotle University of Thessaloniki, Third department of Obstetrics and Gynecology

    Thessaloniki, Thessaloniki, 54642

    Ioannis Kallogianidis, Professor, 231 024 2450 ext. +30, ikalogiannidis@gmail.com

    Recruiting

  • Aristotle University of Thesalloniki, Papageorgiou Hospiral

    Thessaloniki, Thessaloniki, 56429

    Dimitrios Tsolakidis, Associate Professor, 2310 999 900 ext. +30, dtgyn@auth.gr

    Recruiting

Other trials in Greece

About this study

Official title: 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.

Read the 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.

Being tested
ERAS group, Control group
Medical subject headings
Pain, Postoperative, Infections

What participants receive

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

  • ERAS groupCombination product

    This group will include patients that achieved a compliance rate that exceeded 80% of the required predetermined criteria of ERAS protocols.

  • Control groupCombination product

    This group will include patients that do not follow the predetermined criteria of ERAS protocols

Study groups in NCT06655506
Study groupRoleWhat they receive
Fulfilled ERAS criteria groupThis group will include patients that achieved a compliance rate that exceeded 80% of the required predetermined criteria of ERAS protocols.
Receives: Combination Product: ERAS group
Control groupThis group will include patients that achieved a compliance rate that did not reach at least 80% of the required predetermined criteria of ERAS protocols.
Receives: Combination Product: Control group

What is being measured

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

  1. Duration of hospitalization

    From date of hospitalization until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months.

    Measured: Up to 30 days postoperatively

  2. Perioperative infections

    Number of participants with postoperative infections (including surgical site, pulmonary and urinary tract infections)

    Measured: Postoperatively (30 days)

Secondary outcomes (5)

  1. Postoperative quality of life

    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).

    Measured: Postoperatively (30 days)

  2. Postoperative morbidity (other than infectious) using the Clavien-Dindo classification

    Major events such as pulmonary embolism,accuse myocardial infarction,etc

    Measured: 30 days

  3. Interval to adjuvant therapy

    The interval between surgical treatment and adjuvant therapy (radiation and/or chemotherapytreatment) will be documented

    Measured: Up to 100 days

  4. Recurrence rates

    Recurrent disease will be monitored through 3 year of follow up

    Measured: 3 years follow-up

  5. Overall survival

    Overall survival of the patients will be measured through 3 year of follow up

    Measured: 3 years follow-up

Timeline

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

  1. First posted23 Oct 2024
  2. Study start20 Oct 2024
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion30 Jul 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
Target duration
60 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06655506
Sponsor's protocol ID
131/2024
Acronym
ERGO
Status last verified
Oct 2024
First submitted
27 Mar 2024
Last updated
23 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be provided upon reasonable request following communication with researchers

Publications

  • Pandraklakis A, Haidopoulos D, Lappas T, Stamatakis E, Valsamidis D, Oikonomou MD, Loutradis D, Rodolakis A, Bisch SP, Nelson G, Thomakos N. Thoracic epidural analgesia as part of an enhanced recovery program in gynecologic oncology: a prospective cohort study. Int J Gynecol Cancer. 2023 Nov 6;33(11):1794-1799. doi: 10.1136/ijgc-2023-004621.

    PubMed 37652530

  • Bogani G, Sarpietro G, Ferrandina G, Gallotta V, DI Donato V, Ditto A, Pinelli C, Casarin J, Ghezzi F, Scambia G, Raspagliesi F. Enhanced recovery after surgery (ERAS) in gynecology oncology. Eur J Surg Oncol. 2021 May;47(5):952-959. doi: 10.1016/j.ejso.2020.10.030. Epub 2020 Oct 28.

    PubMed 33139130

  • Nelson G. Enhanced Recovery in Gynecologic Oncology Surgery-State of the Science. Curr Oncol Rep. 2023 Oct;25(10):1097-1104. doi: 10.1007/s11912-023-01442-0. Epub 2023 Jul 25.

    PubMed 37490193

  • Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21.

    PubMed 37086524

  • Bhandoria GP, Bhandarkar P, Ahuja V, Maheshwari A, Sekhon RK, Gultekin M, Ayhan A, Demirkiran F, Kahramanoglu I, Wan YL, Knapp P, Dobroch J, Zmaczynski A, Jach R, Nelson G. Enhanced Recovery After Surgery (ERAS) in gynecologic oncology: an international survey of peri-operative practice. Int J Gynecol Cancer. 2020 Oct;30(10):1471-1478. doi: 10.1136/ijgc-2020-001683. Epub 2020 Aug 4.

    PubMed 32753562

  • Pergialiotis V, Haidopoulos D, Daponte A, Tsolakidis D, Petousis S, Kalogiannidis I, Vlachos DE, Lygizos V, Fanaki M, Delinasios G, Tzitzis P, Ntailianas P, Theodoulidis V, Margioula Siarkou G, Daponte N, Thomakos N. Implementation Rates and Predictors of Compliance with Enhanced Recovery After Surgery Protocols in Gynecologic Oncology: A Prospective Multi-Institutional Cohort Study. Cancers (Basel). 2025 Dec 15;17(24):3991. doi: 10.3390/cancers17243991.

    PubMed 41463241

Questions about this trial

What is this clinical trial studying?

An observational study of ERAS and Gynecologic Cancer, run by National and Kapodistrian University of Athens at 8 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

Results are not available in the source record.

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

Contact Nikolaos Thomakos, MD, PhD (+302132162291, thomakir@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of hospitalization (time frame: Up to 30 days postoperatively). The study lists 2 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 NCT06655506, which also lists 6 linked publications.

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 23 Oct 2024.

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