Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations--Part I.
G Nelson, A D Altman, A Nick...
https://pubmed.ncbi.nlm.nih.gov/26603969Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
FEMALE
ID07210164
Prehabilitation With Exercise and Immunonutrition (Ocoxin ) in the Perioperative Management of Gynecologic Malignancies Under ERAS Protocol
Led by Aristotle University Of Thessaloniki · Updated on 2025-10-07
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Aristotle University Of Thessaloniki
Lead Sponsor
C
Catalysis SL
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effect of a prehabilitation program combined with Enhanced Recovery After Surgery (ERAS) protocols on patients with gynecological cancers undergoing surgery. The study aims to see if enhancing patients' physical and psychological condition before surgery improves quality of life, reduces hospital stay length, and decreases postoperative complications and readmission rates. This observational trial focuses on cancers of the uterus, ovaries, and cervix treated by laparotomy under ERAS care. Participants in the study are randomly assigned to one of two groups. The experimental group follows a structured preoperative self-guided exercise program including breathing, muscle strengthening, and aerobic exercises, alongside immunonutrition with Ocoxin supplement and usual clinical care such as stopping alcohol and managing anemia and glucose levels. Both groups follow the 21-point ERAS protocol during hospitalization. The control group receives usual clinical care and ERAS protocol adherence without the additional prehabilitation exercises or immunonutrition. During the study, participants will be monitored for postoperative complications up to 30 days after surgery, hospital stay duration until discharge, and overall quality of life up to discharge. Secondary outcomes include hospital readmission within 90 days, time to start additional cancer treatments, and assessments of cachexia and sexual health. Researchers will collect data through clinical follow-up and patient-reported outcomes, with participation lasting through hospitalization and up to 90 days post-surgery.
CONDITIONS
Brief Title
Pre-habilitation Within ERAS Protocol for Gynecologic Oncology Surgery: The Pre_ERAS Study
Who Can Participate
Age: 18Years - 85Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Diagnosed with endometrial, ovarian, or cervical cancer treated with laparotomy after tumor board approval
- Aged between 18 and 85 years
- General health status with ASA score I to III
- Agree to follow the Enhanced Recovery After Surgery (ERAS) protocol
- Understand and speak Greek sufficiently
- Provide signed informed consent to participate
You will not qualify if you...
- Performance status worse than ECOG 2 or ASA score higher than III
- Have not been informed about the study or have not provided written consent
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - Preoperative period until surgery
Participants in the prehabilitation group follow a structured preoperative self-guided exercise program and receive immunonutrition with Ocoxin, alongside usual clinical care before surgery.
Participants record exercise activity at home; clinical visits as per usual care
Surgery and Immediate Post-operative Care
Duration - Hospital stay up to discharge (up to 4 days)
Participants undergo gynecologic oncology surgery and receive care following the Enhanced Recovery After Surgery (ERAS) protocol during hospitalization.
Hospitalization with daily clinical assessments
Post-operative Follow-up
Duration - Up to 90 days post-surgery
Participants are monitored for postoperative complications, quality of life, and hospital readmission up to 90 days after surgery.
Follow-up visits or contacts up to 90 days post-surgery
Trial Site Locations
Total: 1 location
1
General Hospital of Papageorgiou
Thessaloniki, Greece, 56429
Actively Recruiting
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Research Team
D
Dimitrios Tsolakidis C. MD, PhD, Professor OB&GYN
P
Panagiotis Tzitzis M. MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Role and impact of multimodal prehabilitation for gynecologic oncology patients in an Enhanced Recovery After Surgery (ERAS) program.
Ester Miralpeix, Gemma Mancebo, Sonia Gayete...
https://pubmed.ncbi.nlm.nih.gov/31473663Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations--Part II.
G Nelson, A D Altman, A Nick...
https://pubmed.ncbi.nlm.nih.gov/26757238Guidelines for Perioperative Care in Cytoreductive Surgery (CRS) with or without hyperthermic IntraPEritoneal chemotherapy (HIPEC): Enhanced Recovery After Surgery (ERAS®) Society Recommendations - Part II: Postoperative management and special considerations.
Martin Hübner, Shigeki Kusamura, Laurent Villeneuve...
https://pubmed.ncbi.nlm.nih.gov/32826114Outcomes of enhanced recovery after surgery (ERAS) in gynecologic oncology - A systematic review and meta-analysis.
S P Bisch, C A Jago, E Kalogera...
https://pubmed.ncbi.nlm.nih.gov/33388155Prehabilitation in an ERAS program for endometrial cancer patients: impact on post-operative recovery.
Ester Miralpeix, Berta Fabregó, Cristina Rodriguez-Cosmen...
https://pubmed.ncbi.nlm.nih.gov/36898697Immunonutrition in ovarian cancer: clinical and immunological impact?
Annamaria Ferrero, Daniela Vassallo, Massimo Geuna...
https://pubmed.ncbi.nlm.nih.gov/36047379The role of immunonutritional support in cancer treatment: Current evidence.
Isabel Prieto, Sara Montemuiño, Javier Luna...
https://pubmed.ncbi.nlm.nih.gov/27931879Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update.
Gregg Nelson, Jamie Bakkum-Gamez, Eleftheria Kalogera...
https://pubmed.ncbi.nlm.nih.gov/30877144Enhanced 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/37086524