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

Ovarian Cancer Clinical Trial

— ERAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04696276
• Other study ID #: 8/11-09-2019
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2021
• Source: University of West Attica
• Contact: MARIA BOURAZANI, PhDc
• Phone: 6955587809
• Email: mbourazani[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 gynecolodic 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Gynecologic Cancer
• Hysterectomy
• Ovarian Cancer

Intervention

Other:
• ERAS protocol
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.

Locations

Country	Name	City	State
Greece	Saint Savvas Anticancer Hospital	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
University of West Attica

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital leght of stay (LOS)	Measuring how many days will stay in hospital for recovery. It is defined as the time frame from the day of operation to discharge from the hospital (unit: days).	up to 30 postoperative days
Primary	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. As lower the number on pain scale as better the outcome.	up to 3 postoperative days
Primary	Hospital Complications	The evaluation of postoperative complications such as bleeding, thrombosis and inflammation.	up to 5 postoperative days
Primary	Mobilization	Mobilization time, which is defined as the time frame from the end of operation to the ability to walk without external assistance (unit: hours). Patient will performe a six-minutes-walk.	up to 3 postoperative days
Secondary	Depression-Stress- anxiety	The evaluation of the presentation or not, of the patients 'depression, of the patients' emotional state (anxiety-depression) for their current state of health. Using HADS scale. Scores for each sub scale (depression and anxiety) are summed-up and range from 0-21. Values from 0-7 indicate normal levels, 8-10 are border values and from 11-21 are considered as pathologicals.	at baseline, the preoperation day, then one week after surgery and one month after surgery
Secondary	Readmission	Readmission rate by 30 days after discharge from the hospital	up to 30 postoperative days

External Links

•   ePoster