Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients

Обзор

The aim of this study is to investigate whether single-use gastroscopes used bedside can reduce the time from indication to procedure compared with re-usable gastroscopes used at the endoscopy unit in patients referred to a subacute gastroscopy. Participants in the first period will be scheduled for gastroscopy with a re-usable gastroscope in the endoscopy unit, whereas participants during the second period will have a gastroscopy performed at the ward (bed-side) with a single-use gastroscope.

Вмешательства

• Устройство Ambu aScope Gastro
  CE-marked single-use gastroscopes from Ambu are used in the single-use group.
• Устройство Diagnostic gastroscopes, Olympus
  Reusable gastroscopes from Olympus are used in the reusable group.

Первичные конечные точки

• Time from the indication/decision for early endoscopy to procedure [Срок оценки: From indication to procedure, up to two weeks]

Вторичные конечные точки (12)

• Time from indication to the discharge [Срок оценки: From indication to discharge, up to 3 months]
• Time from procedure to discharge [Срок оценки: From procedure to discharge, up to 3 months]
• Duration of the procedure [Срок оценки: During the procedure]
• Did the patient need sedation or local anesthetic throat spray [Срок оценки: During the procedure]
• Technical success [Срок оценки: From admission to discharge, up to 3 months]
• Sufficient ability to target the biopsy if taken [Срок оценки: During the procedure]
• Complications to gastroscopy [Срок оценки: 24 and 72 hour follow-up after procedure]
• 30th day mortality [Срок оценки: 30 days]
• Readmission [Срок оценки: 30 days after procedure]
• The necessity for a new gastroscopy, including the reasons justifying it [Срок оценки: During admission, up to 3 months]
• Endoscopists' rating of the gastroscope [Срок оценки: Right after procedure]
• Learning curve for nurses at the surgical department [Срок оценки: During the second period (one year)]

Критерии участия

Критерии включения

• Patients of any gender, 18 years of age or older admitted to the acute section of the surgical department (Kir2) at Zealand University Hospital referred to early EGD without general anesthesia.

Критерии исключения

• ASA-score of 4 or higher
• Unstable patient
• Suspicion of ventricular retention
• Suspicion of active bleeders
• Need for expert endoscopist to perform the procedure, e.g. stenting
• Patients < 18 years of age

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Zealand University Hospital — Køge

Публикации

• Rodriguez de Santiago E, Dinis-Ribeiro M, Pohl H, Agrawal D, Arvanitakis M, Baddeley R, Bak E, Bhandari P, Bretthauer M, Burga P, Donnelly L, Eickhoff A, Hayee B, Kaminski MF, Karlovic K, Lorenzo-Zuniga V, Pellise M, Pioche M, Siau K, Siersema PD, Stableforth W, Tham TC, Triantafyllou K, Tringali A, Veitch A, Voiosu AM, Webster GJ, Vienne A, Beilenhoff U, Bisschops R, Hassan C, Gralnek IM, Messman PMID 35803275
• Namburar S, von Renteln D, Damianos J, Bradish L, Barrett J, Aguilera-Fish A, Cushman-Roisin B, Pohl H. Estimating the environmental impact of disposable endoscopic equipment and endoscopes. Gut. 2022 Jul;71(7):1326-1331. doi: 10.1136/gutjnl-2021-324729. Epub 2021 Dec 1. PMID 34853058
• Le NNT, Hernandez LV, Vakil N, Guda N, Patnode C, Jolliet O. Environmental and health outcomes of single-use versus reusable duodenoscopes. Gastrointest Endosc. 2022 Dec;96(6):1002-1008. doi: 10.1016/j.gie.2022.06.014. Epub 2022 Jun 17. PMID 35718068
• Cennamo V, Botter A, Landi S, Graziosi F, Bassi M, Dabizzi E, Ghersi S, Cerone G, Bonfiglioli R. Can single-use versus standard duodenoscope improve ergonomics in ERCP? A comparative, simulation-based pilot study. Endosc Int Open. 2024 Mar 18;12(3):E419-E427. doi: 10.1055/a-2231-7393. eCollection 2024 Mar. PMID 38504744
• Bang JY, Sutton B, Hawes R, Varadarajulu S. Concept of disposable duodenoscope: at what cost? Gut. 2019 Nov;68(11):1915-1917. doi: 10.1136/gutjnl-2019-318227. Epub 2019 Feb 12. No abstract available. PMID 30772837
• Larsen S, Kalloo A, Hutfless S. The hidden cost of colonoscopy including cost of reprocessing and infection rate: the implications for disposable colonoscopes. Gut. 2020 Feb;69(2):197-200. doi: 10.1136/gutjnl-2019-319108. Epub 2019 Aug 14. No abstract available. PMID 31413166
• Deb A, Perisetti A, Goyal H, Aloysius MM, Sachdeva S, Dahiya D, Sharma N, Thosani N. Gastrointestinal Endoscopy-Associated Infections: Update on an Emerging Issue. Dig Dis Sci. 2022 May;67(5):1718-1732. doi: 10.1007/s10620-022-07441-8. Epub 2022 Mar 9. PMID 35262904
• Barakat MT, Banerjee S. Novel Algorithms for Reprocessing, Drying and Storing Endoscopes. Gastrointest Endosc Clin N Am. 2020 Oct;30(4):677-691. doi: 10.1016/j.giec.2020.06.003. Epub 2020 Jul 30. PMID 32891225

Идентификаторы

NCT: NCT06771102 · SUSUES_bedsideGAS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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