Applicability of Enhanced Recovery After Surgery Protocols in the Therapeutic Endoscopy Suite: a Single-Center Randomized Prospective Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Endoscopic Submucosal Dissection
- Sponsor
- Istituto Clinico Humanitas
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- airway protection
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
airway protection
Time Frame: during procedure
Desaturations, aspiration or any acute event requiring airway protection
Rate of ESD-related adverse events
Time Frame: 48 hours after procedure
such as bleeding or perforation (defined as any such procedure-related complication that compromises the completeness of the procedure and/or results in the unplanned patient hospital admission) or occurrence of Post Endoscopic submucosal dissection Coagulation Syndrome (PECS). (defined as the presence of signs of inflammation, such as fever, leukocytosis or C-reactive protein in the presence of localized abdominal pain in patients without evidence of perforation to
Secondary Outcomes
- Abdominal pain(at 3 and 6 hours after endoscopy)
- Overall patient satisfaction(24-48 hours after procedure)
- PADSS: Post Anesthetic Discharge Scoring System (evaluated from 0 to 2, using: Vital signs, Activity and mental status, Pain, nausea and/or vomiting, Surgical bleeding, Intake and output)(in the first 4 hours after ESD)
- Post-procedural Recovery(24-48 hours after procedure)
- Analgesic requirements(in the 24 hours after ESD)