Milla Ortved, Julia Dagnæs-Hansen, Hein V Stroomberg, Thomas Kistorp, Malene Rohrsted, Søren Schwartz Sørensen, Andreas Røder
{"title":"开放标签随机临床试验调查机器人辅助肾移植与开放肾移植（ORAKTx）相比是否能减少手术并发症：一项随机临床试验的研究方案。","authors":"Milla Ortved, Julia Dagnæs-Hansen, Hein V Stroomberg, Thomas Kistorp, Malene Rohrsted, Søren Schwartz Sørensen, Andreas Røder","doi":"10.1186/s13063-024-08706-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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 on 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 (RCT) have compared RAKT to OKT. In this study, we will explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation.</p><p><strong>Methods: </strong>This is a single-site, open-label, randomised clinical trial comparing RAKT to OKT. Participants are adult recipients of kidney transplantation 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 2 years to evaluate secondary outcomes including recovery, late complications and kidney graft function. This is designed as a superiority trial and planned analyses will follow intention-to-treat principles.</p><p><strong>Discussion: </strong>Studies indicate RAKT can reduce several surgical complications, but the lack of RCTs limits the extrapolation of these results to justify replacing 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.</p><p><strong>Trial registration: </strong>The trial was prospectively registered with ClinicalTrials.gov on February 15th, 2023, with the identifier NCT05730257.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"8"},"PeriodicalIF":2.0000,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11702044/pdf/","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Milla Ortved, Julia Dagnæs-Hansen, Hein V Stroomberg, Thomas Kistorp, Malene Rohrsted, Søren Schwartz Sørensen, Andreas Røder\",\"doi\":\"10.1186/s13063-024-08706-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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 on 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 (RCT) have compared RAKT to OKT. In this study, we will explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation.</p><p><strong>Methods: </strong>This is a single-site, open-label, randomised clinical trial comparing RAKT to OKT. Participants are adult recipients of kidney transplantation 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 2 years to evaluate secondary outcomes including recovery, late complications and kidney graft function. This is designed as a superiority trial and planned analyses will follow intention-to-treat principles.</p><p><strong>Discussion: </strong>Studies indicate RAKT can reduce several surgical complications, but the lack of RCTs limits the extrapolation of these results to justify replacing 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.</p><p><strong>Trial registration: </strong>The trial was prospectively registered with ClinicalTrials.gov on February 15th, 2023, with the identifier NCT05730257.</p>\",\"PeriodicalId\":23333,\"journal\":{\"name\":\"Trials\",\"volume\":\"26 1\",\"pages\":\"8\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-01-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11702044/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s13063-024-08706-5\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13063-024-08706-5","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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.
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 on 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 (RCT) have compared RAKT to OKT. In this study, we will explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation.
Methods: This is a single-site, open-label, randomised clinical trial comparing RAKT to OKT. Participants are adult recipients of kidney transplantation 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 2 years to evaluate secondary outcomes including recovery, late complications and kidney graft function. This is designed as a superiority trial and planned analyses will follow intention-to-treat principles.
Discussion: Studies indicate RAKT can reduce several surgical complications, but the lack of RCTs limits the extrapolation of these results to justify replacing 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 with ClinicalTrials.gov on February 15th, 2023, with the identifier NCT05730257.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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