Investigating robot-assisted surgery for kidney transplantation complications
Open-label Randomized Clinical Trial Investigating Whether Robot-Assisted Kidney Transplantation Can Reduce Surgical Complications Compared to Open Kidney Transplantation; The ORAKTx Trial
This study is testing if robot-assisted kidney transplantation can lead to fewer complications and better recovery for adults compared to traditional open surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 2 sites (Copenhagen, N and 1 other locations) |
| Trial ID | NCT05730257 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if robot-assisted kidney transplantation can reduce surgical complications within 30 days compared to traditional open surgery. Adult recipients of kidney transplants will be randomly assigned to either the robot-assisted or open surgery group, with both groups receiving care according to current guidelines. The trial will assess outcomes such as vascular complications and overall patient recovery following the procedures. Conducted at Rigshospitalet, Denmark's largest transplantation center, the study seeks to enhance surgical techniques and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adult patients undergoing kidney transplantation, whether from dialysis or pre-emptive situations.
Not a fit: Patients with complex vascular anatomy or previous surgeries that complicate access to the graft site may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer surgical complications and improved recovery for kidney transplant patients.
How similar studies have performed: Previous studies have indicated that robot-assisted surgery can reduce complications in various surgical procedures, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Highly complex vascular anatomy in the donor kidney requiring multiple anastomoses as evaluated by surgeon * 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 * Patients who are unable to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision
Where this trial is running
Copenhagen, N and 1 other locations
- Urological Research Unit, Rigshospitalet — Copenhagen, N, Denmark (Recruiting)
- Department of Nephrology, Rigshospitalet — Copenhagen, Denmark (Not_yet_recruiting)
Study contacts
- Principal investigator: Andreas Roeder, MD, PhD — Rigshospitalet, Denmark
- Study coordinator: Milla Ortved, MD
- Email: milla.ortved@regionh.dk
- Phone: +4535456152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.