Recruiting NCT06771102
Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ambu aScope Gastro, Diagnostic gastroscopes, Olympus.
- Who it may be relevant to
- Registry conditions: Upper Gastrointestinal Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Ambu aScope Gastro
CE-marked single-use gastroscopes from Ambu are used in the single-use group. - Device Diagnostic gastroscopes, Olympus
Reusable gastroscopes from Olympus are used in the reusable group.
Primary outcome measures
- Time from the indication/decision for early endoscopy to procedure [Time frame: From indication to procedure, up to two weeks]
Secondary outcome measures (12)
- Time from indication to the discharge [Time frame: From indication to discharge, up to 3 months]
- Time from procedure to discharge [Time frame: From procedure to discharge, up to 3 months]
- Duration of the procedure [Time frame: During the procedure]
- Did the patient need sedation or local anesthetic throat spray [Time frame: During the procedure]
- Technical success [Time frame: From admission to discharge, up to 3 months]
- Sufficient ability to target the biopsy if taken [Time frame: During the procedure]
- Complications to gastroscopy [Time frame: 24 and 72 hour follow-up after procedure]
- 30th day mortality [Time frame: 30 days]
- Readmission [Time frame: 30 days after procedure]
- The necessity for a new gastroscopy, including the reasons justifying it [Time frame: During admission, up to 3 months]
- Endoscopists' rating of the gastroscope [Time frame: Right after procedure]
- Learning curve for nurses at the surgical department [Time frame: During the second period (one year)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Zealand University Hospital — Køge
Publications
- 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
Identifiers
NCT: NCT06771102 · SUSUES_bedsideGAS