Enhanced Recovery Protocols in Gynecologic Oncology

NCT06655506 | Recruiting

• 1 other identifier: 131/2024
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 8

Brief 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. 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.

Conditions

ERAS; Gynecologic Cancer; Perioperative Complication; Postoperative Pain; Quality of Life; Infections

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 30 days postoperatively

• Perioperative infections

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

  Postoperatively (30 days)

Secondary Outcomes (5)

• Postoperative quality of life

  Postoperatively (30 days)

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

  30 days

• Interval to adjuvant therapy

  Up to 100 days

• Recurrence rates

  3 years follow-up

• Overall survival

  3 years follow-up

Study Arms (2)

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

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

Interventions

ERAS group COMBINATION_PRODUCT

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

Fulfilled ERAS criteria group

Control group COMBINATION_PRODUCT

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

Control group

Eligibility Criteria

• Age: 25 Years - 85 Years
• Gender Eligibility Details: Participant eligibility is not based on self-representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• University of Thessaly: collaborator
• Aristotle University Of Thessaloniki: collaborator
• Metaxa Hospital: collaborator
• Saint Savvas Anticancer Hospital: collaborator

Study Sites (8)

First department of Obstetrics and Gynecology

Athens, Athens, 11523, Greece

RECRUITING

Agios Savvas Anticancer Hospital

Athens, Attica, 11522, Greece

RECRUITING

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

Athens, Attica, 11528, Greece

RECRUITING

University of Thessaly

Larissa, Larissa, 413 34, Greece

RECRUITING

Metaxa Anticancer Hospital

Athens, Piraeus, 18537, Greece

NOT YET RECRUITING

Aristotle University of Thessaloniki, Second department of Obstetrics and Gynecology

Thessaloniki, Thessaloniki, 54642, Greece

RECRUITING

Aristotle University of Thessaloniki, Third department of Obstetrics and Gynecology

Thessaloniki, Thessaloniki, 54642, Greece

RECRUITING

Aristotle University of Thesalloniki, Papageorgiou Hospiral

Thessaloniki, Thessaloniki, 56429, Greece

RECRUITING

Related Publications (6)

• 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.

  PMID: 37652530 BACKGROUND

• 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.

  PMID: 33139130 BACKGROUND

• 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.

  PMID: 37490193 BACKGROUND

• 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.

  PMID: 37086524 BACKGROUND

• 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.

  PMID: 32753562 BACKGROUND

• 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.

  PMID: 41463241 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Infections

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Nikolaos Thomakos, MD, PhD

CONTACT

+302132162291; thomakir@hotmail.com

Vasilios Pergialiotis, MD, PhD, MSc

CONTACT

+302132162291; pergialiotis@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, MSc, Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: October 23, 2024
• Study Start: October 20, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Following study completion and up to 5 years from publication of findings.
• Access Criteria: Data will be provided through a dedicated de-identified redcap database

Locations

GR (8)