About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
ERAS group
Combination productThis group will include patients that achieved a compliance rate that exceeded 80% of the required predetermined criteria of ERAS protocols.
Control group
Combination productThis group will include patients that do not follow the predetermined criteria of ERAS protocols
Treatment groups
Trial outcomes
Primary outcomes
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.
Perioperative infections
Number of participants with postoperative infections (including surgical site, pulmonary and urinary tract infections)
Secondary outcomes
Postoperative quality of life
Documentation of quality of life using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C40) and the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires. The EORTC-QLQ C30 involves 30 questions that are rated from 1 (no impact on quality of life) to 4 (debilitating symptoms). The FACT-G assesses physical, family, emotional and functional wellbeing through 27 questions that are scaled from 0 (no impact) to 4 (very much).
Postoperative morbidity (other than infectious) using the Clavien-Dindo classification
Major events such as pulmonary embolism,accuse myocardial infarction,etc
Interval to adjuvant therapy
The interval between surgical treatment and adjuvant therapy (radiation and/or chemotherapytreatment) will be documented
Recurrence rates
Recurrent disease will be monitored through 3 year of follow up
Sponsors and contacts
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National and Kapodistrian University of Athens
Lead sponsor
University of Thessaly
Collaborator
Aristotle University Of Thessaloniki
Collaborator
Metaxa Hospital
Collaborator
Saint Savvas Anticancer Hospital
Collaborator