Open-label Randomised Clinical Trial on Robot-Assisted Kidney Transplantation

Explanation for the Choice of Comparators

The European Association of Urology (EAU) considers open surgery as the standard surgical approach for kidney transplantation. RAKT, however, offers benefits such as a magnified image and added degrees of freedom during vascular suturing, potentially improving the quality of vascular anastomoses.

Intervention Description

Both RAKT and OKT procedures involve the preparation of the graft, administration of general anaesthesia, and peri-operative medications. A baseline biopsy of the graft is performed for comparison in case of later graft failure. Post-surgery, patients receive intravenous oxycodone and local anaesthetic in the incisions.

ARM 1 (Control Group): Open Kidney Transplantation

This procedure involves a Gibson incision, preparation of the iliac vascular bed, and anastomosis of the kidney graft vessels to the external iliac vessels. The ureterovesical anastomosis is performed with a synthetic monofilament suture, and the graft is placed in the cavity.

Arm 2 (Intervention Group): Robot-Assisted Kidney Transplantation

RAKT involves a small Pfannenstiel incision, placement of a hand-port, and preparation of the iliac vascular bed. The kidney is introduced through the hand port, and vascular anastomoses are performed end-to-side to the external iliac vessels. The kidney is placed in the retroperitoneal cavity, and the ureterovesical anastomosis is performed similarly to the control group.

Outcomes

The trial measures primary outcomes related to vascular complications and major surgical complications within 30 days of surgery. Secondary outcomes focus on recovery, graft function, and late complications, assessed through an in-depth review of the patient’s electronic health record (EHR).

Participant Timeline

Participants are randomised after informed consent is obtained. Intra-operative data and graft data are registered in the EHR at the time of surgery. Post-operative care includes regular ultrasound assessments and urology consults as needed.

Sample Size

A power calculation determined a sample size of 106 participants, anticipating a 10% drop-out rate. The study hypothesises that RAKT will lead to significant reductions in vascular and major surgical complications compared to OKT.

Recruitment

Recruitment involves urological evaluation prior to kidney transplantation, with broad eligibility criteria representative of the general kidney recipient population. The enrolment period is expected to last 2.5 years, with inclusion ceasing after 106 participants have undergone the operation.