Open-label randomised clinical trial investigating whether Robot-Assisted Kidney Transplantation can reduce surgical complications compared to Open Kidney Transplantation (ORAKTx): Study protocol for a randomised clinical trial

Open-label randomised clinical trial investigating whether Robot-Assisted Kidney Transplantation can reduce surgical complications compared to Open Kidney Transplantation (ORAKTx): Study protocol for a randomised clinical trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Open-label randomised clinical trial investigating whether Robot-Assisted Kidney Transplantation can reduce surgical complications compared to Open Kidney Transplantation (ORAKTx): Study protocol for a randomised clinical trial Milla Ortved, Julia Dagnæs-Hansen, Hein Vincent Stroomberg, Thomas Kistorp, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3868879/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 01 Mar, 2024 Read the published version in European Urology → Version 1 posted You are reading this latest preprint version Abstract Background: Kidney transplantation is the ultimate treatment for end-stage kidney disease. Function of the kidney graft is not only dependent on medical factors but also a complication-free surgical procedure. In the event of major surgical complications, the kidney graft is potentially lost and the patient will return to the waiting list which may be long. To optimise peri-operative care and reduce complications, robot-assisted kidney transplantation (RAKT) has been introduced as an alternative to open kidney transplantation (OKT), but to our knowledge no randomised clinical trials are comparing RAKT to OKT. We will explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation. Methods: This a single-site, open-label, randomised clinical trial comparing RAKT to OKT. Participants are adult recipients of kidney transplantation and all participants are recruited from Copenhagen University Hospital – Rigshospitalet, Denmark. The study plans to include 106 participants who will be randomised in a 1:1 manner between OKT and RAKT. Primary outcomes are vascular- and major surgical complications at 30 days post-operatively. Participants will be followed for two years to evaluate secondary outcomes including recovery, late complications and kidney graft function. This is designed as a superiority trial and planned analyses are as intention-to-treat. Discussion: Studies indicate RAKT can reduce several surgical complications, but the lack of RCTs limits the extrapolation of these results to justify the replacement of an open approach with a robot-assisted one. Ultimately, the introduction of new surgical techniques should be as vigorously tested as any other new treatments. However, reducing surgical complications that compromise graft viability could lead to improved patient care and survival. Trial registration : The trial was prospectively registered on February 15th 2023 on clinicaltrials.gov with NCT-identifier 05730257. Kidney Transplantation Robotic Surgery Urology Randomised Controlled Trial End Stage Renal Disease. Figures Figure 1 Full Text Cite Share Download PDF Status: Published Journal Publication published 01 Mar, 2024 Read the published version in European Urology → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3868879","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":285361112,"identity":"71732da3-e375-41a5-8ff6-1613c31c68ea","order_by":0,"name":"Milla Ortved","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA7UlEQVRIiWNgGAWjYDACZubGAzC2xAcgwQZBCXi0MDaAtfAAseQMorQwIGmR5oEI4dei2w7U8oPBJt9eIvngbds9NnZ97L3HHjCUpeHUYnaYseFgD0OaZY9EWrJ1zrO05Daec+kGDOdy8Go5wMNw2ICH54yZdM6Bw8lsEjlmEoxtFfht+QPWcv6btMWB/8RpOQy2hb2HTZrhwAE7qBb8DjssY5BmwHO8zdiy50ByAhvQhRIJ5/B4//zhgw/fVNgYsDczP7zx44CdvXx7j5nEh7JknFogwADBTGwAkQkENKAAe1IUj4JRMApGwcgAAGjuT0RJ6ULvAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0003-2021-2281","institution":"Copenhagen University Hospital: Rigshospitalet","correspondingAuthor":true,"prefix":"","firstName":"Milla","middleName":"","lastName":"Ortved","suffix":""},{"id":285361113,"identity":"a110131f-84aa-4ee5-9e67-e4ecb8bea57e","order_by":1,"name":"Julia Dagnæs-Hansen","email":"","orcid":"","institution":"Copenhagen University Hospital: Rigshospitalet","correspondingAuthor":false,"prefix":"","firstName":"Julia","middleName":"","lastName":"Dagnæs-Hansen","suffix":""},{"id":285361114,"identity":"f74de182-9924-4ddf-a3b5-7d0c129910e5","order_by":2,"name":"Hein Vincent Stroomberg","email":"","orcid":"","institution":"Copenhagen University Hospital: Rigshospitalet","correspondingAuthor":false,"prefix":"","firstName":"Hein","middleName":"Vincent","lastName":"Stroomberg","suffix":""},{"id":285361115,"identity":"ae057728-b39a-4cce-b773-41f7ef1c92eb","order_by":3,"name":"Thomas Kistorp","email":"","orcid":"","institution":"Copenhagen University Hospital: Rigshospitalet","correspondingAuthor":false,"prefix":"","firstName":"Thomas","middleName":"","lastName":"Kistorp","suffix":""},{"id":285361116,"identity":"f496201b-90ad-45a5-9080-a881a9ea53ad","order_by":4,"name":"Malene Rohrsted","email":"","orcid":"","institution":"Copenhagen University Hospital: Rigshospitalet","correspondingAuthor":false,"prefix":"","firstName":"Malene","middleName":"","lastName":"Rohrsted","suffix":""},{"id":285361117,"identity":"1c344023-5504-49c9-8920-b7374003b2e5","order_by":5,"name":"Søren Schwartz Sørensen","email":"","orcid":"","institution":"Copenhagen University Hospital: Rigshospitalet","correspondingAuthor":false,"prefix":"","firstName":"Søren","middleName":"Schwartz","lastName":"Sørensen","suffix":""},{"id":285361118,"identity":"e80e22f9-e8f2-4f22-9c16-5f176c650f30","order_by":6,"name":"Andreas Røder","email":"","orcid":"","institution":"Copenhagen University Hospital: Rigshospitalet","correspondingAuthor":false,"prefix":"","firstName":"Andreas","middleName":"","lastName":"Røder","suffix":""}],"badges":[],"createdAt":"2024-01-16 05:36:09","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3868879/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3868879/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1016/S0302-2838(24)00378-6","type":"published","date":"2024-03-01T17:20:16+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":54039196,"identity":"02798000-36f2-4f4e-8965-acb76c51494e","added_by":"auto","created_at":"2024-04-03 17:19:46","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":16508,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version.\u003c/p\u003e","description":"","filename":"Figure1participanttimelineORAKTx.png","url":"https://assets-eu.researchsquare.com/files/rs-3868879/v1/89b430b1f49d7d88914077a0.png"},{"id":54040077,"identity":"b17286d3-2b8a-4417-97f4-89103fb04960","added_by":"auto","created_at":"2024-04-03 17:27:50","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":466679,"visible":true,"origin":"","legend":"","description":"","filename":"ProtocolpublishORAKTx.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3868879/v1_covered_03f295e1-806e-4729-892b-15871a700538.pdf"}],"financialInterests":"","formattedTitle":"Open-label randomised clinical trial investigating whether Robot-Assisted Kidney Transplantation can reduce surgical complications compared to Open Kidney Transplantation (ORAKTx): Study protocol for a randomised clinical trial","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Kidney Transplantation, Robotic Surgery, Urology, Randomised Controlled Trial, End Stage Renal Disease.","lastPublishedDoi":"10.21203/rs.3.rs-3868879/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3868879/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e Kidney transplantation is the ultimate treatment for end-stage kidney disease. Function of the kidney graft is not only dependent on medical factors but also a complication-free surgical procedure. In the event of major surgical complications, the kidney graft is potentially lost and the patient will return to the waiting list which may be long. To optimise peri-operative care and reduce complications, robot-assisted kidney transplantation (RAKT) has been introduced as an alternative to open kidney transplantation (OKT), but to our knowledge no randomised clinical trials are comparing RAKT to OKT. We will explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e This a single-site, open-label, randomised clinical trial comparing RAKT to OKT. Participants are adult recipients of kidney transplantation and all participants are recruited from Copenhagen University Hospital – Rigshospitalet, Denmark. The study plans to include 106 participants who will be randomised in a 1:1 manner between OKT and RAKT. Primary outcomes are vascular- and major surgical complications at 30 days post-operatively. Participants will be followed for two years to evaluate secondary outcomes including recovery, late complications and kidney graft function. This is designed as a superiority trial and planned analyses are as intention-to-treat.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion: \u003c/strong\u003eStudies indicate RAKT can reduce several surgical complications, but the lack of RCTs limits the extrapolation of these results to justify the replacement of an open approach with a robot-assisted one. Ultimately, the introduction of new surgical techniques should be as vigorously tested as any other new treatments. However, reducing surgical complications that compromise graft viability could lead to improved patient care and survival.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e:\u0026nbsp;The trial was prospectively registered on February 15th 2023 on clinicaltrials.gov with NCT-identifier 05730257.\u003c/p\u003e","manuscriptTitle":"Open-label randomised clinical trial investigating whether Robot-Assisted Kidney Transplantation can reduce surgical complications compared to Open Kidney Transplantation (ORAKTx): Study protocol for a randomised clinical trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-04-03 17:19:41","doi":"10.21203/rs.3.rs-3868879/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"68e654f3-dc0f-4750-811c-e8fa270687a7","owner":[],"postedDate":"April 3rd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-11-27T07:28:25+00:00","versionOfRecord":{"articleIdentity":"rs-3868879","link":"https://doi.org/10.1016/S0302-2838(24)00378-6","journal":{"identity":"european-urology","isVorOnly":true,"title":"European Urology"},"publishedOn":"2024-03-01 17:20:16","publishedOnDateReadable":"March 1st, 2024"},"versionCreatedAt":"2024-04-03 17:19:41","video":"","vorDoi":"10.1016/S0302-2838(24)00378-6","vorDoiUrl":"https://doi.org/10.1016/S0302-2838(24)00378-6","workflowStages":[]},"version":"v1","identity":"rs-3868879","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3868879","identity":"rs-3868879","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}