ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy of Benign or Malignant Tumors of the Uterus. A Stepped-wedge Cluster Randomized Clinical Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Uterine Neoplasms
- Sponsor
- Ospedale Regina Montis Regalis
- Enrollment
- 1800
- Locations
- 1
- Primary Endpoint
- Length of stay
- Last Updated
- 4 years ago
Overview
Brief Summary
The study assesses the impact on quality of care of implementing the ERAS (Enhanced Recovery After Surgery) protocol for hysterectomy of benign or malignant tumors of the uterus in the network of public hospitals in the Regione Piemonte (North-West Italy). Every hospital is a cluster entering the study treating patients according to its current clinical practice. On the basis of a randomized order, each hospital switches from current clinical practice to the adoption of the ERAS protocol.
Detailed Description
ERAS (Enhanced Recovery After Surgery) protocol is a multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. Even if efficacy and safety of ERAS protocol in gynaecological surgery is well-established in the literature, its implementation is limited to few selected centres in Piemonte. The aim of the study is to extend the implementation of the ERAS protocol to whole regional network of hospitals. Specific objectives are to estimate its impact on different dimensions of quality of care, including length of stay, complications and patient satisfaction, and to identify possible barriers or facilitating factors.
Investigators
Dr. Andrea Puppo
Gynecologists
Ospedale Regina Montis Regalis
Eligibility Criteria
Inclusion Criteria
- •All the hospital wards within the Piemonte Region performing hysterectomy.
- •All the patients receiving an elective hysterectomy for benign or malignant tumors of the uterus.
Exclusion Criteria
- •Hospital wards performing less than 20 expected cases per year
- •Emergency hysterectomy
- •Hysterectomy for pelvic floor disorders
- •High severity cases not allowing ERAS protocol implementation (i.e. American Society of Anesthesiologists score: ASA V).
Outcomes
Primary Outcomes
Length of stay
Time Frame: 12 days after admission
Mean length of stay calculated as difference between date of discharge and date of admission of the hospitalization for surgery, excluding length of stay \>12 days (98th percentile of the expected distribution).
Secondary Outcomes
- Length of stay >12 days(30 days after admission)
- Recovery after surgery(24 hours after surgery)
- Complications(30 days after discharge)
- Emergency visits after discharge(30 days after discharge)
- Transfer to intensive care unit(30 days after surgery)
- Hospital admissions after discharge(30 days after discharge)
- Reintervention(30 days after surgery)
- Healthcare costs(30 days after discharge)
- Patients' satisfaction(15 days after discharge)