Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-10-20
2026-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Control group
This group will include patients that do not follow the predetermined criteria of ERAS protocols
Interventions
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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 do not follow the predetermined criteria of ERAS protocols
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
85 Years
FEMALE
No
Sponsors
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University of Thessaly
OTHER
Aristotle University Of Thessaloniki
OTHER
Metaxa Hospital
OTHER
Saint Savvas Anticancer Hospital
OTHER
National and Kapodistrian University of Athens
OTHER
Responsible Party
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Nikolaos Thomakos
MD, PhD, MSc, Associate Professor of Obstetrics and Gynecology
Locations
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First department of Obstetrics and Gynecology
Athens, Athens, Greece
Agios Savvas Anticancer Hospital
Athens, Attica, Greece
First department of Obstetrics and Gynecology, National and Kapodistrian University of Athens
Athens, Attica, Greece
University of Thessaly
Larissa, Larissa, Greece
Metaxa Anticancer Hospital
Athens, Piraeus, Greece
Aristotle University of Thessaloniki, Second department of Obstetrics and Gynecology
Thessaloniki, Thessaloniki, Greece
Aristotle University of Thessaloniki, Third department of Obstetrics and Gynecology
Thessaloniki, Thessaloniki, Greece
Aristotle University of Thesalloniki, Papageorgiou Hospiral
Thessaloniki, Thessaloniki, Greece
Countries
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Central Contacts
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Facility Contacts
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Vasilios Lygizos, MD
Role: backup
Maria Fanaki, MD
Role: backup
Filippos Ntailianas, MD
Role: backup
References
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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.
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.
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.
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.
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.
Other Identifiers
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131/2024
Identifier Type: -
Identifier Source: org_study_id
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