Applicability of Enhanced Recovery After Surgery Protocols in the Therapeutic Endoscopy Suite (ERATE)

Istituto Clinico Humanitas

Status: Not yet enrolling

Conditions: Colorectal Endoscopic Submucosal Dissection

Treatments: Procedure: ERAS protocols

Study type: Interventional

Funder types: Other

Identifiers

NCT06409676

ERATE ID. 3764

Details and patient eligibility

About

This study aims to investigate the impact of implementing ERAS protocols on patient outcomes in therapeutic endoscopy, focusing on patients undergoing ESD. Although considered a less invasive alternative to conventional surgical resection, ESD can still result in significant physiological stress, postoperative discomfort, and potential complications. By exploring the application of ERAS principles to therapeutic endoscopy and evaluating their effectiveness, this study aims to address the current lack of knowledge in this field and promote the adoption of ERAS principles in managing ESD patients. Ultimately, the goal is to assess if the implementation of the ERAS process in these therapeutic endoscopy procedures can reduce procedure-related complications, improve patient outcomes, and enhance after-procedural recovery.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All >18 years-old patients scheduled for ESD for any indication;
• Patients who were able to give informed written consent.

Exclusion criteria

• • Patients who were not able or refused to give informed written consent.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

ERAS group

Experimental group

Description:

Participants will receive the ERAS protocol tailored for endoscopic procedures

Treatment:

Procedure: ERAS protocols

Standard care group

No Intervention group

Description:

Participants will receive conventional pre-endoscopic care, including basic patient education, standard bowel preparation, preoperative fasting guidelines, medication management, and routine preoperative assessment