Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece

Not Applicable

Completed

Conditions: Endometrial Cancer
Ovarian Cancer
Hysterectomy
Gynecologic Cancer

Interventions: Other: ERAS protocol

Registration Number: NCT04696276

Lead Sponsor: University of West Attica

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 101

Inclusion Criteria

Greek language speakers
Have complete mental clarity
Age >18 years

Exclusion Criteria

Refusal to sign consent
Patients receiving treatment for chronic pain
Patients receiving antipsychotic therapy, Psychopathy
They have acute or chronic kidney and / or liver disease
History or family history of malignant hyperthermia
Known allergy to propofol, desflurane, or any other anesthetic agent
Impairment of cognitive function or communication
History of postoperative delirium

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-ERAS	ERAS protocol	will receive ERAS pathways care

Primary Outcome Measures

Name	Time	Method
Length of Hospital Stay (LOS)	up to 30 postoperative days	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).
Pain Levels	up to 3 postoperative days	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.
Number of Participants With the Ability to Getting up in a Chair Within 18h	within the first 18 postoperative hours	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.
Number of Participants With the Ability of Full Mobilization Within 18h Postoperatively	within the first 18 hours after the surgery	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).
Early Feeding	up to 6 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Early Mobilization of the Digestive System	within 24 hours post surgery	Number of participants who had their digestive system function on time, with hunger, bowel sounds and bowel movements within the first 24 hours postoperatively
Early Discontinuation of IV Administration	within 24 h post surgery	Number of participants who had early discontinuation of IV fluids and conversion to per os within 24 hours postoperatively
Number of Participants Who Had Their Urinary Catheter Removal	within the first 24h after surgery	Number of participants who had their urinary catheter removed within 24 hours postoperatively
Number of Participants Who Had Their Drainage Removal Within 24h	within 24h post surgery	Number of Participants who had their drainage removal within 24 hours postoperatively
Blood Transfusion	within 48 hours post surgery	Number of participants who had blood transfusion during their intraoperative and postoperative time
Postoperative Complications	up to 5 postoperative days	The evaluation of postoperative complications such as bleeding, thrombosis and inflammation.
Readmission	up to 30 postoperative days	Readmission rate by 30 days after discharge from the hospital