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We aim to evaluate whether the use of single-use gastroscopes at the bedside can reduce the time from clinical indication to procedure compared to reusable gastroscopes used in the endoscopy unit for patients referred for subacute gastroscopy.
Participants in the first period will be scheduled for gastroscopy with a reusable gastroscope in the endoscopy unit, whereas participants during the second period will have a gastroscopy performed at the hospital department (bed-side) with a single-use gastroscope.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reusable gastroscope in the endoscopy unit | Active Comparator | In the first period the subacute gastroscopies will be performed with a reusable gastroscope in the endoscopy unit. |
|
| Single-use gastroscope bedside in the patient's room | Experimental | In the second period the subacute gastroscopies will be performed with a reusable gastroscope in bedside in the patients' rooms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambu aScope Gastro | Device | CE-marked single-use gastroscopes from Ambu are used in the single-use group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from the indication/decision for early endoscopy to procedure | From indication to procedure, up to two weeks | |
| Endoscopists' rating of the gastroscope | The endoscopists' rating of the gastroscope | Immediately after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time from admission to procedure | From admission to procedure, up to 3 months | |
| Time from procedure to discharge | From procedure to discharge, up to 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mustafa Bulut | Surgical department of Zealand University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Køge | 4600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34186052 | Background | Slivka A, Ross AS, Sejpal DV, Petersen BT, Bruno MJ, Pleskow DK, Muthusamy VR, Chennat JS, Krishnamoorthi R, Lee C, Martin JA, Poley JW, Cohen JM, Thaker AM, Peetermans JA, Rousseau MJ, Tirrell GP, Kozarek RA; EXALT Single-use Duodenoscope Study Group. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointest Endosc. 2021 Dec;94(6):1046-1055. doi: 10.1016/j.gie.2021.06.017. Epub 2021 Jun 26. | |
| 31706060 |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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Prospective, quality assurance study. Non-randomized, controlled single center feasibility study. Comparing a period where subacute gastroscopies are performed in the endoscopy unit (reusable gastroscopes) with a period where they are performed bedside in the patients room (single-use gastroscopes).
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| Diagnostic gastroscopes, Olympus | Device | Reusable gastroscopes from Olympus are used in the reusable group. |
|
| Duration of the procedure |
| During the procedure |
| Did the patient need sedation or local anaesthetic throat spray? | Frequency of use of sedation and/or local anaesthetic throat spray in each group. | During the procedure |
| Technical success | Technical success is defined as the ability to complete the procedure adequately based on the indication and guidelines. | From admission to discharge, up to 3 months |
| Complications to gastroscopy | 24 and 72 hour follow-up after procedure |
| Need for converting to general anaesthesia or reusable gastroscope | Did the patient need a new gastroscopy during admission? If so, what is the reason for that, according to the patient's medical record? | During admission, up to 3 months |
| Findings during the procedure | The frequency of various findings observed during the procedure in each group (e.g., gastric ulcer, varices, stenosis), based on the procedure documentation in the patients' medical records. | During the procedure |
| Background |
| Muthusamy VR, Bruno MJ, Kozarek RA, Petersen BT, Pleskow DK, Sejpal DV, Slivka A, Peetermans JA, Rousseau MJ, Tirrell GP, Ross AS. Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2108-2117.e3. doi: 10.1016/j.cgh.2019.10.052. Epub 2019 Nov 6. |
| 35048654 | Background | Bai Z, Wang R, Cheng G, Ma D, Ibrahim M, Chawla S, Qi X. Outcomes of early versus delayed endoscopy in cirrhotic patients with acute variceal bleeding: a systematic review with meta-analysis. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e868-e876. doi: 10.1097/MEG.0000000000002282. |
| 36174643 | Background | Gralnek IM, Camus Duboc M, Garcia-Pagan JC, Fuccio L, Karstensen JG, Hucl T, Jovanovic I, Awadie H, Hernandez-Gea V, Tantau M, Ebigbo A, Ibrahim M, Vlachogiannakos J, Burgmans MC, Rosasco R, Triantafyllou K. Endoscopic diagnosis and management of esophagogastric variceal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Nov;54(11):1094-1120. doi: 10.1055/a-1939-4887. Epub 2022 Sep 29. |
| 29848459 | Background | Jeong N, Kim KS, Jung YS, Kim T, Shin SM. Delayed endoscopy is associated with increased mortality in upper gastrointestinal hemorrhage. Am J Emerg Med. 2019 Feb;37(2):277-280. doi: 10.1016/j.ajem.2018.05.049. Epub 2018 May 24. |
| 31080604 | Background | Siau K, Hodson J, Ingram R, Baxter A, Widlak MM, Sharratt C, Baker GM, Troth T, Hicken B, Tahir F, Magrabi M, Yousaf N, Grant C, Poon D, Khalil H, Lee HL, White JR, Tan H, Samani S, Hooper P, Ahmed S, Amin M, Mahgoub S, Asghar K, Leet F, Harborne MJ, Polewiczowska B, Khan S, Anjum MR, McFarlane M, Mozdiak E, O'Flynn LD, Blee IC, Molyneux RM, Kurian A, Abbas SN, Abbasi A, Karim A, Yasin A, Khattak F, White J, Ahmed R, Morgan JA, Alleyne L, Alam MA, Palaniyappan N, Rodger VJ, Sawhney P, Aslam N, Okeke T, Lawson A, Cheung D, Reid JP, Awasthi A, Anderson MR, Timothy JR, Pattni S, Ahmad S, Townson G, Shearman J, Giljaca V, Brookes MJ, Disney BR, Guha N, Thomas T, Norman A, Wurm P, Shah A, Fisher NC, Ishaq S, Major G. Time to endoscopy for acute upper gastrointestinal bleeding: Results from a prospective multicentre trainee-led audit. United European Gastroenterol J. 2019 Mar;7(2):199-209. doi: 10.1177/2050640618811491. Epub 2018 Oct 28. |
| 28512647 | Background | Garg SK, Anugwom C, Campbell J, Wadhwa V, Gupta N, Lopez R, Shergill S, Sanaka MR. Early esophagogastroduodenoscopy is associated with better Outcomes in upper gastrointestinal bleeding: a nationwide study. Endosc Int Open. 2017 May;5(5):E376-E386. doi: 10.1055/s-0042-121665. |
| 33567467 | Background | Gralnek IM, Stanley AJ, Morris AJ, Camus M, Lau J, Lanas A, Laursen SB, Radaelli F, Papanikolaou IS, Curdia Goncalves T, Dinis-Ribeiro M, Awadie H, Braun G, de Groot N, Udd M, Sanchez-Yague A, Neeman Z, van Hooft JE. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021. Endoscopy. 2021 Mar;53(3):300-332. doi: 10.1055/a-1369-5274. Epub 2021 Feb 10. |