ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy.

Not Applicable

• Conditions: Uterine Neoplasms
• Interventions: Procedure: ERAS protocol

• Registration Number: NCT04063072
• Lead Sponsor: Ospedale Regina Montis Regalis

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.

Study Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Study Start: 2019-09-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-01
• Last Update Posted: 2021-06-02
• Primary Completion: 2021-07-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1800

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ERAS protocol	ERAS protocol	Perioperative care for hysterectomy of benign or malignant tumors of the uterus is managed according to ERAS protocol.

Primary Outcome Measures

Name	Time	Method
Length of stay	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 Outcome Measures

Name	Time	Method
Length of stay >12 days	30 days after admission	Rate of patients with a length of stay \>12 days
Recovery after surgery	24 hours after surgery	Score of quality of recovery at 24 hours after surgery, assessed with the questionnaire Quality of Recovery (QoR-15), a 15-items instrument, with responses recorded on a 11-point Likert-type scale form 0 (worst scenario) to 10 (best scenario) and an overall score ranging from 0 (poor recovery) to 150 (excellent recovery).; A visual analogue scale (VAS), ranging from 0 (worst imaginable health state) to 10 (worst imaginable health state) is also supplied as summary evaluation.
Complications	30 days after discharge	Rate of surgical and medical complication after surgery For surgical complications: Comprehensive Complication Index
Emergency visits after discharge	30 days after discharge	Rate of emergency visit in the first month after discharge
Transfer to intensive care unit	30 days after surgery	Rate of transfers to intensive care unit after surgery
Hospital admissions after discharge	30 days after discharge	Rate of new admissions in the first month after discharge
Reintervention	30 days after surgery	Rate of reintervention in the first month after surgery, excluding planned interventions
Healthcare costs	30 days after discharge	Mean healthcare costs from pre admission visit to 30 days after discharge
Patients' satisfaction	15 days after discharge	Score of patients' satisfaction measured 2 weeks after discharge, assessed with the questionnaire Surgical Satisfaction Questionnaire (SSQ8) supplied by telephone. SSQ8 is a 8-items instrument, with responses recorded on a 5-point Likert-type scale from 0 (worst scenario) to 4 (best scenario) and an overall score ranging from 0 (very unsatisfied) to 32 (very satisfied).

Trial Locations

Locations (1)

Ospedale Regina Montis Regalis; 🇮🇹 Mondovì, Italy