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

Last updated: June 1, 2021
Sponsor: Ospedale Regina Montis Regalis
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Uterine Fibroids

Leiomyomas

Treatment

N/A

Clinical Study ID

NCT04063072
ERAS-Gyneco-Piemonte
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All the hospital wards within the Piemonte Region performing hysterectomy.
  • All the patients receiving an elective hysterectomy for benign or malignant tumors ofthe uterus.

Exclusion

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 Societyof Anesthesiologists score: ASA V).

Study Design

Total Participants: 1800
Study Start date:
September 01, 2019
Estimated Completion Date:
October 31, 2021

Study 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.

Connect with a study center

  • Ospedale Regina Montis Regalis

    Mondovì,
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.