Enhanced Recovery Protocols in Gynecologic Oncology

NCT ID: NCT06655506

Last Updated: 2024-10-23

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-20

Study Completion Date

2026-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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ERAS Gynecologic Cancer Perioperative Complication Postoperative Pain Quality of Life Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type COMBINATION_PRODUCT

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

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type COMBINATION_PRODUCT

Control group

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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)
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role collaborator

Metaxa Hospital

OTHER

Sponsor Role collaborator

Saint Savvas Anticancer Hospital

OTHER

Sponsor Role collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Nikolaos Thomakos

MD, PhD, MSc, Associate Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First department of Obstetrics and Gynecology

Athens, Athens, Greece

Site Status RECRUITING

Agios Savvas Anticancer Hospital

Athens, Attica, Greece

Site Status RECRUITING

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

Athens, Attica, Greece

Site Status RECRUITING

University of Thessaly

Larissa, Larissa, Greece

Site Status RECRUITING

Metaxa Anticancer Hospital

Athens, Piraeus, Greece

Site Status NOT_YET_RECRUITING

Aristotle University of Thessaloniki, Second department of Obstetrics and Gynecology

Thessaloniki, Thessaloniki, Greece

Site Status RECRUITING

Aristotle University of Thessaloniki, Third department of Obstetrics and Gynecology

Thessaloniki, Thessaloniki, Greece

Site Status RECRUITING

Aristotle University of Thesalloniki, Papageorgiou Hospiral

Thessaloniki, Thessaloniki, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Nikolaos Thomakos, MD, PhD

Role: CONTACT

+302132162291

Vasilios Pergialiotis, MD, PhD, MSc

Role: CONTACT

+302132162291

Facility Contacts

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Vasilios Pergialiotis, MD

Role: primary

+306947326459

Dimitrios Papatheodorou, MD, PhD

Role: primary

2106409408 ext. +30

Vasilios Pergialiotis, Assistant Professor

Role: primary

+306947326459

Vasilios Lygizos, MD

Role: backup

Maria Fanaki, MD

Role: backup

Filippos Ntailianas, MD

Role: backup

Alexandros Daponte, Professor

Role: primary

2411115654 ext. +30

Georgios Vorgias, MD, PhD

Role: primary

Stamatios Petousis, Assistant Professor

Role: primary

6934050763 ext. +30

Ioannis Kallogianidis, Professor

Role: primary

231 024 2450 ext. +30

Dimitrios Tsolakidis, Associate Professor

Role: primary

2310 999 900 ext. +30

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.

Reference Type BACKGROUND
PMID: 37652530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33139130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37490193 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37086524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32753562 (View on PubMed)

Other Identifiers

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131/2024

Identifier Type: -

Identifier Source: org_study_id

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