The Enhanced Recovery After Surgery (ERAS) program includes preoperative counseling, fasting avoidance, non-opioid analgesia, fluid balance, normothermia and early mobilization. ERAS pathways were developed to reduce hospital length of stay, reduce costs and decrease perioperative opioid requirements, and be beneficial for patients. We propose the hypothesis that the ERAS pathway could reduce the length of stay (LOS) in hospital for patients undergoing major gynecologic oncology surgery (MGOS). Patients were randomly allocated in two groups: An ERAS pathway group including preoperative counseling, early feeding/mobilization, and opioid-sparing multimodal analgesia; and a classic model group of post operative recovery as control.
The Gynecological Cancer of the inner genital organs includes ovarian cancer, endometrial and cervical cancer and its therapeutic approach is surgical removal of the organ with cancer. The last decade has developed various postoperative recovery protocols aimed at safe and rapid recovery of the patient after a surgery and early discharge from the hospital. These protocols are known as ERAS (Enhanced Recovery After Surgery) protocols or Fast-Track (FT) and combine various evidence-based perioperative care techniques. The ERAS protocols include specific approaches preoperative, intraoperative and postoperative, by the multidisciplinary team (surgeon, anesthetist and nurse), and aim at reducing the postoperative stress and pain, fasten the feeding and the mobilization of the patient after the surgery and rapid the hospital discharge. This trial is designed to evaluate the superiority of the ERAS pathway to conventional non-ERAS clinical practice in reducing the LOS. The results may provide new insight into the clinical applications of the ERAS pathway for MGOS. This doctoral thesis aims to compare the effectiveness of the Protocol ERAS against the classical model of recovery, in the postoperative recovery of patients with Gynecological Cancer undergoing MGOS, in a Public Oncology Hospital in Greece. The importance of ERAS programs is expected to emerge in the length of hospital stay, in pain control, in perioperative stress, in the early feeding and mobilization of patients who have undergone MGOS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
101
special approaches in three phases preoperatively, intraoperatively and postoperatively, by an interdisciplinary team comprising of the surgeon, the anesthesiologist and the nurse. The combination of these techniques reduces the reaction to postoperative stress, relieves acute postoperative pain, restores the patient immediately to their original feeding and mobilization habits, thus reducing the time required for their complete recovery.
Saint Savvas Anticancer Hospital
Athens, Attica, Greece
Length of Hospital Stay (LOS)
Measuring how many days the participants will stay in hospital for the post-op recovery. It is defined as the time frame from the day of the surgery to the day of discharge from the hospital (unit: days).
Time frame: up to 30 postoperative days
Pain Levels
Evaluation of analgesia and correlation of requirements with opioid analgesics; by recording of postoperative pain levels and the evaluation of the effectiveness of analgesic treatment of patients. Using Numbered pain Scale, from 0 that means no pain at all, to 10 that means the worst pain. As lower the number on pain scale as better the outcome.
Time frame: up to 3 postoperative days
Number of Participants With the Ability to Getting up in a Chair Within 18h
The number of participants who had the ability to have a sit steadily on a chair himself, within the first 18 hours after the surgery.
Time frame: within the first 18 postoperative hours
Number of Participants With the Ability of Full Mobilization Within 18h Postoperatively
The participants should be able to stand on their feet, walk in the room, go to the toilet and make a short walk in the surgical ward within the first 18 hours after the surgery. Mobilization time, which is defined as the time frame from the end of the operation until they are able to walk without external assistance (unit: hours).
Time frame: within the first 18 hours after the surgery
Early Feeding
Feeding within the first 6 hours after the surgery. The participants should be able to drink clear fluids (water, tea,chamomile, apple juice, filter coffee, jelo) with or without sweeteners, given that they don't have PONV.
Time frame: up to 6 hours postoperatively
Early Mobilization of the Digestive System
Number of participants who had their digestive system function on time, with hunger, bowel sounds and bowel movements within the first 24 hours postoperatively
Time frame: within 24 hours post surgery
Early Discontinuation of IV Administration
Number of participants who had early discontinuation of IV fluids and conversion to per os within 24 hours postoperatively
Time frame: within 24 h post surgery
Number of Participants Who Had Their Urinary Catheter Removal
Number of participants who had their urinary catheter removed within 24 hours postoperatively
Time frame: within the first 24h after surgery
Number of Participants Who Had Their Drainage Removal Within 24h
Number of Participants who had their drainage removal within 24 hours postoperatively
Time frame: within 24h post surgery
Blood Transfusion
Number of participants who had blood transfusion during their intraoperative and postoperative time
Time frame: within 48 hours post surgery
Postoperative Complications
The evaluation of postoperative complications such as bleeding, thrombosis and inflammation.
Time frame: up to 5 postoperative days
Readmission
Readmission rate by 30 days after discharge from the hospital
Time frame: up to 30 postoperative days
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