Clinical trial NCT06409676: Applicability of Enhanced Recovery After Surgery Protocols in the Therapeutic Endoscopy Suite
Official title: Applicability of Enhanced Recovery After Surgery Protocols in the Therapeutic Endoscopy Suite: a Single-Center Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Endoscopic Submucosal Dissection
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Rate of ESD-related adverse events
timeFrame: 48 hours after procedure
measure: airway protection
timeFrame: during procedure
Secondary outcomes:
measure: Post-procedural Recovery
timeFrame: 24-48 hours after procedure
measure: Overall patient satisfaction
timeFrame: 24-48 hours after procedure
measure: Abdominal pain
timeFrame: at 3 and 6 hours after endoscopy
measure: Analgesic requirements
timeFrame: in the 24 hours after ESD
measure: 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)
timeFrame: in the first 4 hours after ESD
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Humanitas Research Hospital
Study officials:
References:
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