Enhanced Recovery in Gynecologic Oncology Surgery-State of the Science.
Gregg Nelson
https://pubmed.ncbi.nlm.nih.gov/37490193/Actively Recruiting
Led by National and Kapodistrian University of Athens · Updated on 2024-10-23
600
Participants Needed
8
Research Sites
17 weeks
Total Duration
Enhanced Recovery After Surgery ERAS protocols are designed to provide a structured approach for managing patients after surgery, promoting evidence-based care to support normal body function during the perioperative period and help patients recover sooner. This study focuses on women with gynecological cancer in Greece, aiming to assess how well ERAS protocols can be followed and their feasibility in clinical practice. It also compares outcomes between patients who meet a minimum compliance level with ERAS criteria and those who do not. Participants will be grouped based on their compliance with the ERAS protocols one group includes patients who exceed 80% compliance with predetermined ERAS criteria, while the other group includes patients who do not meet this threshold. The ERAS protocols involve steps such as pre-admission education, nutritional care before surgery, specific medication plans, standardized anesthesia, fluid management during surgery, multimodal pain relief, early movement, and early removal of urinary catheters. During the study, patients will be registered before surgery and monitored for various outcomes, including length of hospital stay and perioperative infections within 30 days after surgery. Other assessments include postoperative quality of life, complications using a classification system, time until additional therapy, and long-term outcomes like recurrence rates and overall survival over three years. A quality assurance program will support both groups to ensure proper data collection and care standards.
CONDITIONS
Enhanced Recovery Protocols in Gynecologic Oncology
N
Nikolaos Thomakos, MD, PhD
V
Vasilios Pergialiotis, MD, PhD, MSc
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National and Kapodistrian University of Athens
Lead Sponsor
University of Thessaly
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 30 days postoperatively
Participants undergo surgery and receive immediate post-operative care as part of the Enhanced Recovery protocols.
Approximately 1 hospital stay and post-operative assessments
Duration - Up to 3 years
Participants are monitored after surgery to assess recovery, postoperative quality of life, morbidity, interval to adjuvant therapy, and longer-term outcomes.
Follow-up visits up to 3 years including assessments at 30 days, 100 days, and annually for recurrence and survival
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Gregg Nelson
https://pubmed.ncbi.nlm.nih.gov/37490193/Giorgio Bogani, Giuseppe Sarpietro, Gabriella Ferrandina...
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https://pubmed.ncbi.nlm.nih.gov/37652530/G Nelson, C Fotopoulou, J Taylor...
https://pubmed.ncbi.nlm.nih.gov/37086524/National and Kapodistrian University of Athens
Lead Sponsor
University of Thessaly
Collaborating Sponsor