Enhanced Recovery Protocols in Gynecologic Oncology

Официальное название

Enhanced Recovery Protocols in Gynecological Cancer Patients: a Feasibility Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт ERAS group
  This group will include patients that achieved a compliance rate that exceeded 80% of the required predetermined criteria of ERAS protocols.
• Комбинированный продукт Control group
  This group will include patients that do not follow the predetermined criteria of ERAS protocols

Первичные конечные точки

• Duration of hospitalization [Срок оценки: Up to 30 days postoperatively]
• Perioperative infections [Срок оценки: Postoperatively (30 days)]

Вторичные конечные точки (5)

• Postoperative quality of life [Срок оценки: Postoperatively (30 days)]
• Postoperative morbidity (other than infectious) using the Clavien-Dindo classification [Срок оценки: 30 days]
• Interval to adjuvant therapy [Срок оценки: Up to 100 days]
• Recurrence rates [Срок оценки: 3 years follow-up]
• Overall survival [Срок оценки: 3 years follow-up]

Критерии участия

Критерии включения

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

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Греция · 8 центров

• First department of Obstetrics and Gynecology — Athens
• Agios Savvas Anticancer Hospital — Athens
• First department of Obstetrics and Gynecology, National and Kapodistrian University of Ath — Athens
• University of Thessaly — Larissa
• Metaxa Anticancer Hospital — Athens
• Aristotle University of Thessaloniki, Second department of Obstetrics and Gynecology — Thessaloniki
• Aristotle University of Thessaloniki, Third department of Obstetrics and Gynecology — Thessaloniki
• Aristotle University of Thesalloniki, Papageorgiou Hospiral — Thessaloniki

Публикации

• 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
• 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
• 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
• 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
• 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
• 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 (Base PMID 41463241

Идентификаторы

NCT: NCT06655506 · 131/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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