NCT06655506

Enhanced Recovery Protocols in Gynecologic Oncology

Enhanced Recovery Protocols in Gynecological Cancer Patients: a Feasibility Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: Female
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ERAS
• Gynecologic Cancer
• Perioperative Complication
• Postoperative Pain
• Quality of Life
• Infections

Interventions

Type	Name	Description
COMBINATION_PRODUCT	ERAS group	This group will include patients that achieved a compliance rate that exceeded 80% of the required predetermined criteria of ERAS protocols.
COMBINATION_PRODUCT	Control group	This group will include patients that do not follow the predetermined criteria of ERAS protocols

Timeline

• Start date: 2024-10-20
• Primary completion: 2026-03-31
• Completion: 2026-07-30
• First posted: 2024-10-23
• Last updated: 2024-10-23

Locations

8 sites across 1 country: Greece