Living Donors
Conditions
Interventions
This is a prospective, randomized, three-arm, open-label clinical trial conducted at a single center, the Hospital das Clínicas of the University of São Paulo Medical School (HC-FMUSP). A total of 51
Sponsors
Hospital das Clínicas da Faculdade de Medicina da USP - HC FMUSP
Hospital das Clínicas da Faculdade de Medicina da USP - HC FMUSP
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged >18 years. Voluntary living kidney donors approved for transplantation by the institutional medical, ethical, and legal committees
Exclusion criteria
Exclusion criteria: Contraindications to laparoscopic or robotic approaches. Uncontrolled comorbidities. Refusal to provide informed consent. Left kidney donors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the robotic technique will provide greater preservation of renal artery and vein length compared with the open and laparoscopic techniques. The preserved length of the renal artery and vein will be calculated using data from the preoperative CT angiography and from measurements obtained after organ retrieval, as follows: preserved arterial or venous length (in percentage) will be equal to the arterial or venous length up to the first bifurcation of the vessel measured on the back table (in millimeters), divided by the arterial or venous length on CT angiography from its origin at the aorta or inferior vena cava to the first bifurcation of the vessel (in millimeters), multiplied by 100 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate, in the donor, differences among the three surgical techniques with respect to length of hospital stay, postoperative pain intensity assessed by the Visual Analog Scale (VAS) at 24 and 48 hours, blood loss, total operative time, conversion rate, intraoperative complication rate, warm ischemia time, incidence of surgical site infection, postoperative ileus, decrease in hemoglobin, and estimated glomerular filtration rate (eGFR) at 1 month. In the recipient, the incidence of delayed graft function (need for dialysis in the first postoperative week), postoperative estimated glomerular filtration rate (eGFR) at 7 days and at 1 and 3 months, incidence of renovascular thrombosis, ureteral complications, and graft loss will also be assessed | — |
Countries
Brazil
Contacts
Public ContactHenri Morgan
Hospital das Clínicas da Faculdade de Medicina da USP - HC FMUSP
Outcome results
None listed