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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS group | Experimental | Participants will receive the ERAS protocol tailored for endoscopic procedures |
|
| Standard care group | No Intervention | Participants will receive conventional pre-endoscopic care, including basic patient education, standard bowel preparation, preoperative fasting guidelines, medication management, and routine preoperative assessment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERAS protocols | Procedure | Enhanced Recovery After Surgery (ERAS) guidelines are evidence-based recommendations aimed at improving patient outcomes and reducing complications after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 hours after procedure |
| airway protection | Desaturations, aspiration or any acute event requiring airway protection | during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedural Recovery | Assessed using the Postoperative Quality of Recovery Scale (PQRS) | 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)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Research Hospital | Milan | 20089 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32003714 | Background | Ficari F, Borghi F, Catarci M, Scatizzi M, Alagna V, Bachini I, Baldazzi G, Bardi U, Benedetti M, Beretta L, Bertocchi E, Caliendo D, Campagnacci R, Cardinali A, Carlini M, Cascella M, Cassini D, Ciotti S, Cirio A, Coata P, Conti D, DelRio P, Di Marco C, Ferla L, Fiorindi C, Garulli G, Genzano C, Guercioni G, Marra B, Maurizi A, Monzani R, Pace U, Pandolfini L, Parisi A, Pavanello M, Pecorelli N, Pellegrino L, Persiani R, Pirozzi F, Pirrera B, Rizzo A, Rolfo M, Romagnoli S, Ruffo G, Sciuto A, Marini P. Enhanced recovery pathways in colorectal surgery: a consensus paper by the Associazione Chirurghi Ospedalieri Italiani (ACOI) and the PeriOperative Italian Society (POIS). G Chir. 2019 Jul-Aug;40(4Supp.):1-40. | |
| 21985180 |
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| 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) | 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 ) | 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 | in the first 4 hours after ESD |
| Background |
| Ahmed J, Khan S, Lim M, Chandrasekaran TV, MacFie J. Enhanced recovery after surgery protocols - compliance and variations in practice during routine colorectal surgery. Colorectal Dis. 2012 Sep;14(9):1045-51. doi: 10.1111/j.1463-1318.2011.02856.x. |
| 31096498 | Background | Wang Y, Zhu Z, Li H, Sun Y, Xie G, Cheng B, Ji F, Fang X. Effects of preoperative oral carbohydrates on patients undergoing ESD surgery under general anesthesia: A randomized control study. Medicine (Baltimore). 2019 May;98(20):e15669. doi: 10.1097/MD.0000000000015669. |
| 35723625 | Background | Li J, Kang G, Liu T, Liu Z, Guo T. Feasibility of Enhanced Recovery After Surgery Protocols Implemented Perioperatively in Endoscopic Submucosal Dissection for Early Gastric Cancer: A Single-Center Retrospective Study. J Laparoendosc Adv Surg Tech A. 2023 Jan;33(1):74-80. doi: 10.1089/lap.2022.0269. Epub 2022 Jun 20. |
| 34950259 | Background | Wang Y, Zhou D, Xiong W, Ge S. Modified protocol for Enhanced Recovery After Surgery is beneficial for achalasia patients undergoing peroral endoscopic myotomy: a randomized prospective trial. Wideochir Inne Tech Maloinwazyjne. 2021 Dec;16(4):656-663. doi: 10.5114/wiitm.2021.104013. Epub 2021 Mar 1. |
| 24368573 | Background | Greco M, Capretti G, Beretta L, Gemma M, Pecorelli N, Braga M. Enhanced recovery program in colorectal surgery: a meta-analysis of randomized controlled trials. World J Surg. 2014 Jun;38(6):1531-41. doi: 10.1007/s00268-013-2416-8. |
| 30426190 | Background | Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y. |
| 29306520 | Background | ASGE Standards of Practice Committee; Early DS, Lightdale JR, Vargo JJ 2nd, Acosta RD, Chandrasekhara V, Chathadi KV, Evans JA, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Muthusamy VR, Pasha SF, Saltzman JR, Shergill AK, Cash BD, DeWitt JM. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2018 Feb;87(2):327-337. doi: 10.1016/j.gie.2017.07.018. Epub 2018 Jan 3. No abstract available. |
| 28072722 | Background | Jin S, Liang DD, Chen C, Zhang M, Wang J. Dexmedetomidine prevent postoperative nausea and vomiting on patients during general anesthesia: A PRISMA-compliant meta analysis of randomized controlled trials. Medicine (Baltimore). 2017 Jan;96(1):e5770. doi: 10.1097/MD.0000000000005770. |
| 25225824 | Background | Skolnik A, Gan TJ. Update on the management of postoperative nausea and vomiting. Curr Opin Anaesthesiol. 2014 Dec;27(6):605-9. doi: 10.1097/ACO.0000000000000128. |
| 36527308 | Background | Chen HY, Deng F, Tang SH, Liu W, Yang H, Song JC. Effect of different doses of dexmedetomidine on the median effective concentration of propofol during gastrointestinal endoscopy: a randomized controlled trial. Br J Clin Pharmacol. 2023 Jun;89(6):1799-1808. doi: 10.1111/bcp.15647. Epub 2023 Jan 9. |