ArticleTrials2025
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.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05730257 (Open-label Randomized Clinical Trial Investigating Whether Robot-Assisted Kidney Transplantation Can Reduce Surgical Complications Compared to Open Kidney Transplantation; The ORAKTx Trial), which is not on this map. Cited by 1 paper.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Open-label Randomized Clinical Trial Investigating Whether Robot-Assisted Kidney Transplantation Can Reduce Surgical Complications Compared to Open Kidney Transplantation; The ORAKTx Trial
Who cites it
1 citing paper in PubMed.
- The Italian landscape of robotic-assisted kidney transplantation: results from a national survey.Updates in surgery · 2026Article
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Authors and funding
7 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundKidney 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.
methodsThis 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 registrationThe trial was prospectively registered with ClinicalTrials.gov on February 15th, 2023, with the identifier NCT05730257.
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