Thoracic epidural analgesia as part of an enhanced recovery program in gynecologic oncology: a prospective cohort study.
Anastasios Pandraklakis, Dimitrios Haidopoulos, Theodoros Lappas...
https://pubmed.ncbi.nlm.nih.gov/37652530Actively Recruiting
Age: 25Years - 85Years
FEMALE
ID06655506
Enhanced Recovery Protocols in Gynecological Cancer Patients: a Feasibility Study
Led by National and Kapodistrian University of Athens · Updated on 2024-10-23
600
Participants Needed
8
Research Sites
17 weeks
Total Duration
On this page
Sponsors
N
National and Kapodistrian University of Athens
Lead Sponsor
U
University of Thessaly
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
Enhanced Recovery Protocols in Gynecologic Oncology
Who Can Participate
Age: 25Years - 85Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female patients aged 25 to 85 years
- Diagnosed with gynecological cancer
- ECOG performance status less than 4
- ASA score less than 4
You will not qualify if you...
- Patients with metastatic cancer of non-gynecological origin
- Patients unable to follow ERAS protocol due to medical reasons
- Patients with severe debilitating comorbidities (ECOG status 4, ASA score 4-5)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
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
Post-operative Follow-up
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
Trial Site Locations
Total: 8 locations
1
First department of Obstetrics and Gynecology
Athens, Athens, Greece, 11523
Actively Recruiting
2
Agios Savvas Anticancer Hospital
Athens, Attica, Greece, 11522
Actively Recruiting
3
First department of Obstetrics and Gynecology, National and Kapodistrian University of Athens
Athens, Attica, Greece, 11528
Actively Recruiting
4
University of Thessaly
Larissa, Larissa, Greece, 413 34
Actively Recruiting
5
Metaxa Anticancer Hospital
Athens, Piraeus, Greece, 18537
Not Yet Recruiting
6
Aristotle University of Thessaloniki, Second department of Obstetrics and Gynecology
Thessaloniki, Thessaloniki, Greece, 54642
Actively Recruiting
7
Aristotle University of Thessaloniki, Third department of Obstetrics and Gynecology
Thessaloniki, Thessaloniki, Greece, 54642
Actively Recruiting
8
Aristotle University of Thesalloniki, Papageorgiou Hospiral
Thessaloniki, Thessaloniki, Greece, 56429
Actively Recruiting
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Research Team
N
Nikolaos Thomakos, MD, PhD
V
Vasilios Pergialiotis, MD, PhD, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Enhanced recovery after surgery (ERAS) in gynecology oncology.
Giorgio Bogani, Giuseppe Sarpietro, Gabriella Ferrandina...
https://pubmed.ncbi.nlm.nih.gov/33139130Enhanced Recovery in Gynecologic Oncology Surgery-State of the Science.
Gregg Nelson
https://pubmed.ncbi.nlm.nih.gov/37490193Enhanced recovery after surgery (ERAS®) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update.
G Nelson, C Fotopoulou, J Taylor...
https://pubmed.ncbi.nlm.nih.gov/37086524Enhanced Recovery After Surgery (ERAS) in gynecologic oncology: an international survey of peri-operative practice.
Geetu Prakash Bhandoria, Prashant Bhandarkar, Vijay Ahuja...
https://pubmed.ncbi.nlm.nih.gov/32753562Implementation Rates and Predictors of Compliance with Enhanced Recovery After Surgery Protocols in Gynecologic Oncology: A Prospective Multi-Institutional Cohort Study.
Vasilios Pergialiotis, Dimitrios Haidopoulos, Alexandros Daponte...
https://pubmed.ncbi.nlm.nih.gov/41463241