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Not Yet Recruiting
NCT05730257
Study Investigating Whether Robot-assisted Surgery Can Reduce Surgical Complications Following Kidney Transplantation
Conditions: End Stage Renal Disease, Kidney Transplant; Complications
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 106
Sponsor: Rigshospitalet, Denmark
Location: Denmark
Summary
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.
Eligibility Criteria
Inclusion Criteria:Adult recipients for renal transplantationBoth patients in dialysis as well as pre-emptiveFor recipients of kidney grafts from deceased donors, inclusion depends on the availabilty of the robotic platform and dedicated surgical teamExclusion 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 in recipient prior to transplantationHighly complex vascular anatomy in the donor kidney requiring multiple anastomoses as evaluated by surgeonPrevious kidney transplantation with later allograft nephrectomy as evaluated by the surgeon preoperativelyPatients 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 transplantSevere comorbidities contraindicating robot-assisted surgeryPatients who are unable to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision
Source: ClinicalTrials.gov (NCT05730257). StuddyBuddy aggregates publicly available trial information.