Colorectal Endoscopic Submucosal Dissection
Conditions
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.
Interventions
PROCEDUREERAS protocols
Enhanced Recovery After Surgery (ERAS) guidelines are evidence-based recommendations aimed at improving patient outcomes and reducing complications after surgery.
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| airway protection | during procedure | Desaturations, aspiration or any acute event requiring airway protection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Post-procedural Recovery | 24-48 hours after procedure | Assessed using the Postoperative Quality of Recovery Scale (PQRS) |
| 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 |
| 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 ) |
| 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)) |
Countries
Italy
Outcome results
None listed