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

Ospedale Regina Montis Regalis

Status: Unknown

Conditions: Uterine Neoplasms

Treatments: Procedure: ERAS protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04063072

ERAS-Gyneco-Piemonte

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,800 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,800 participants in 2 patient groups

Usual care

No Intervention group

Description:

Perioperative care for hysterectomy of benign or malignant tumors of the uterus is managed according to current hospital clinical practice.

ERAS protocol

Experimental group

Description:

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

Treatment:

Procedure: ERAS protocol