Clinical trial NCT06655506: Enhanced Recovery Protocols in Gynecologic Oncology
Official title: Enhanced Recovery Protocols in Gynecological Cancer Patients: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ERAS
Gynecologic Cancer
Perioperative Complication
Postoperative Pain
Quality of Life
Infections
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: University of Thessaly
name: Aristotle University Of Thessaloniki
name: Metaxa Hospital
name: Saint Savvas Anticancer Hospital
First posted: 2024-10-23
Enrollment: 600
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Duration of hospitalization
timeFrame: Up to 30 days postoperatively
measure: Perioperative infections
timeFrame: Postoperatively (30 days)
Secondary outcomes:
measure: Postoperative quality of life
timeFrame: Postoperatively (30 days)
measure: Postoperative morbidity (other than infectious) using the Clavien-Dindo classification
timeFrame: 30 days
measure: Interval to adjuvant therapy
timeFrame: Up to 100 days
measure: Recurrence rates
timeFrame: 3 years follow-up
measure: Overall survival
timeFrame: 3 years follow-up
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agios Savvas Anticancer Hospital
state: Attica
city: Athens
country: Greece
facility: First department of Obstetrics and Gynecology, National and Kapodistrian University of Athens
state: Attica
city: Athens
country: Greece
facility: Metaxa Anticancer Hospital
state: Piraeus
city: Athens
country: Greece
facility: First department of Obstetrics and Gynecology
city: Larissa
country: Greece
facility: University of Thessaly
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki, Second department of Obstetrics and Gynecology
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki, Third department of Obstetrics and Gynecology
city: Thessaloniki
country: Greece
facility: Aristotle University of Thesalloniki, Papageorgiou Hospiral
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.