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/26603969/Actively Recruiting
Led by Aristotle University Of Thessaloniki · Updated on 2025-10-07
100
Participants Needed
1
Research Sites
N/A
Total Duration
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
Pre-habilitation Within ERAS Protocol for Gynecologic Oncology Surgery: The Pre_ERAS Study
D
Dimitrios Tsolakidis C. MD, PhD, Professor OB&GYN
P
Panagiotis Tzitzis M. MD, MSc
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Aristotle University Of Thessaloniki
Lead Sponsor
Catalysis SL
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.
1 visit (in-person)
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
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
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Lead Sponsor
Catalysis SL
Collaborating Sponsor