Enhanced Recovery Protocols in Gynecologic Oncology (ERGO)

National and Kapodistrian University of Athens

Status: Enrolling

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

Treatments: Combination Product: Control group; Combination Product: ERAS group

Study type: Observational

Funder types: Other

Identifiers

NCT06655506

131/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

600 participants in 2 patient groups

Fulfilled ERAS criteria group

Description:

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

Treatment:

Combination Product: ERAS group

Control group

Description:

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.

Treatment:

Combination Product: Control group