ERAS, Gynecologic Cancer, Infections, Perioperative Complication, Postoperative Pain, Quality of Life
Conditions
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.
Interventions
COMBINATION_PRODUCTERAS group
This group will include patients that achieved a compliance rate that exceeded 80% of the required predetermined criteria of ERAS protocols.
COMBINATION_PRODUCTControl group
This group will include patients that do not follow the predetermined criteria of ERAS protocols
Sponsors
University of Thessaly
Aristotle University Of Thessaloniki
Metaxa Hospital
Saint Savvas Anticancer Hospital
National and Kapodistrian University of Athens
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospitalization | Up to 30 days postoperatively | 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 | Postoperatively (30 days) | Number of participants with postoperative infections (including surgical site, pulmonary and urinary tract infections) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interval to adjuvant therapy | Up to 100 days | The interval between surgical treatment and adjuvant therapy (radiation and/or chemotherapytreatment) will be documented |
| Postoperative quality of life | Postoperatively (30 days) | 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). |
| Overall survival | 3 years follow-up | Overall survival of the patients will be measured through 3 year of follow up |
| Recurrence rates | 3 years follow-up | Recurrent disease will be monitored through 3 year of follow up |
| Postoperative morbidity (other than infectious) using the Clavien-Dindo classification | 30 days | Major events such as pulmonary embolism,accuse myocardial infarction,etc |
Countries
Greece
Contacts
Primary ContactNikolaos Thomakos, MD, PhD
Backup ContactVasilios Pergialiotis, MD, PhD, MSc
Outcome results
None listed