ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery (ERAS-Colon)

Ospedale Santa Croce-Carle Cuneo

Status: Completed

Conditions: Quality Improvement; Recovery of Function; Perioperative Care; Colorectal Cancer

Treatments: Procedure: ERAS protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04037787

ERAS-Colon-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 colorectal cancer surgery 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 colorectal 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: 2,397 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All the hospital wards within the Piemonte Region performing colorectal cancer surgery
• All the patients receiving an elective surgery for colorectal cancer, with or without protective stoma.

Exclusion criteria

• Hospital wards performing less than 30 expected cases per year
• Emergency surgery
• 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)

---

2,397 participants in 2 patient groups

Usual care

No Intervention group

Description:

Perioperative care for colorectal cancer cancer is managed according to current hospital clinical practice.

ERAS protocol

Experimental group

Description:

Perioperative care for colorectal cancer surgery is managed according to ERAS protocol.

Treatment:

Procedure: ERAS protocol