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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
220
Enhanced Recovery After Surgery (ERAS) guidelines are evidence-based recommendations aimed at improving patient outcomes and reducing complications after surgery.
Humanitas Research Hospital
Milan, Italy
Rate of ESD-related adverse events
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
Time frame: 48 hours after procedure
airway protection
Desaturations, aspiration or any acute event requiring airway protection
Time frame: during procedure
Post-procedural Recovery
Assessed using the Postoperative Quality of Recovery Scale (PQRS)
Time frame: 24-48 hours after procedure
Overall patient satisfaction
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))
Time frame: 24-48 hours after procedure
Abdominal pain
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)
Time frame: at 3 and 6 hours after endoscopy
Analgesic requirements
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 )
Time frame: in the 24 hours after ESD
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)
% of patients with PADSS \>=9
Time frame: in the first 4 hours after ESD
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