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

NCT06409676 | Not Yet Recruiting

• 1 other identifier: ERATE ID. 3764
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Post-procedural Recovery

  24-48 hours after procedure

• Overall patient satisfaction

  24-48 hours after procedure

• Abdominal pain

  at 3 and 6 hours after endoscopy

• Analgesic requirements

  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)

  in the first 4 hours after ESD

Study Arms (2)

ERAS group

EXPERIMENTAL

Participants will receive the ERAS protocol tailored for endoscopic procedures

Procedure: ERAS protocols

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

Interventions

ERAS protocols PROCEDURE

Enhanced Recovery After Surgery (ERAS) guidelines are evidence-based recommendations aimed at improving patient outcomes and reducing complications after surgery.

ERAS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All \>18 years-old patients scheduled for ESD for any indication;
• Patients who were able to give informed written consent.

You may not qualify if:

• \- Patients who were not able or refused to give informed written consent.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Milan, 20089, Italy

Location

Related Publications (11)

• 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.

  PMID: 32003714 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.

  PMID: 21985180 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.

  PMID: 31096498 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.

  PMID: 35723625 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.

  PMID: 34950259 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.

  PMID: 24368573 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.

  PMID: 30426190 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.

  PMID: 29306520 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.

  PMID: 28072722 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.

  PMID: 25225824 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.

  PMID: 36527308 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: May 10, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-02

Locations

IT (1)