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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Endoscopic Submucosal Dissection
• Interventions: Procedure: ERAS protocols

• Registration Number: NCT06409676
• Lead Sponsor: Istituto Clinico Humanitas

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-05-08
• Study First Posted: 2024-05-10
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Study Start: 2024-10-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS group	ERAS protocols	Participants will receive the ERAS protocol tailored for endoscopic procedures

Primary Outcome Measures

Name	Time	Method
airway protection	during procedure	Desaturations, aspiration or any acute event requiring airway protection
Rate of ESD-related adverse events	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 Outcome Measures

Name	Time	Method
Abdominal pain	at 3 and 6 hours after endoscopy	which will be assessed using the NRS (with a range from 0 to 10, where 0 corresponds to no pain while 10 to the worst pain imaginable)
Overall patient satisfaction	24-48 hours after procedure	which will be evaluated using a 0-10 scale (0 = highly unsatisfactory outcome, 10 = most satisfactory outcome) or the Patient Satisfaction Questionnaire-18 (PSQ-18))
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	% of patients with PADSS \>=9
Post-procedural Recovery	24-48 hours after procedure	Assessed using the Postoperative Quality of Recovery Scale (PQRS)
Analgesic requirements	in the 24 hours after ESD	which will be assessed using the NRS (with a range from 0 to 10, where 0 corresponds to no pain while 10 to the worst pain imaginable )

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Milano, Italy