NCT05730257Active, not recruiting
Study Investigating Whether Robot-assisted Surgery Can Reduce Surgical Complications Following Kidney Transplantation
Open-label Randomized Clinical Trial Investigating Whether Robot-Assisted Kidney Transplantation Can Reduce Surgical Complications Compared to Open Kidney Transplantation; The ORAKTx Trial
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
The purpose of this study is to explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation. Participants are adult recipients of kidney transplantation. Upon entry into the trial participants will be randomly assigned eiher open kidney transplantation or robot-assisted kidney transplantation. The participants in both groups will be treated in accordance with up-to-date guidelines and care. Our hypothesis is that robot-assisted surgery can reduce vascular complications by 15% and/or major surgical complicatons by 20% within 30 days of kidney transplantation compared to open surgery.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 7 Feb 2023
- Start date
- 8 May 2023
- Primary completion date
- 26 Oct 2025
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Chronic kidney disease
- NCT number
- NCT05730257
What you commit to
- Study type: Interventional
- Planned participants: 106
- From 8 May 2023 to the primary completion date, 26 Oct 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- High degree of calcification of the iliac vessels on the level of external iliac artery defined as occurrence of longitudinal plaques on non-contrast CT-scan or other relevant radiological imaging in recipient prior to transplantation
- Previous kidney transplantation with later allograft nephrectomy as evaluated by the surgeon preoperatively
- Patients whose abdominal anatomy may prohibit access to and placement of graft in the iliac fossa as evaluated by the surgeon preoperatively (i.e. previous laparotomy, rectal surgery, herniotomy, current multiple kidney cysts)
- Simultaneous multiple organ transplant
- Severe comorbidities contraindicating robot-assisted surgery
Other
- Highly complex vascular anatomy in the donor kidney requiring multiple anastomoses as evaluated by surgeon
- Patients who are unable to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision
Who the study is looking for
- Adult recipients for renal transplantation
- Both patients in dialysis as well as pre-emptive
- For recipients of kidney grafts from deceased donors, inclusion depends on the availabilty of the robotic platform and dedicated surgical team
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Nephrology, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Urological Research Unit, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.