Open-label Randomized Clinical Trial Investigating Whether Robot-Assisted Kidney Transplantation Can Reduce Surgical Complications Compared to Open Kidney Transplantation; The ORAKTx Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Department of Nephrology, Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Urological Research Unit, Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Milla Ortved, MD
milla.ortved@regionh.dk
+4535456152
Backup
Andreas Roeder, MD, PhD
andreas.roeder@regionh.dk
+4535457195
Time Frame
Start Date: 2023-05-08
Estimated Completion Date: 2027-10
Participants
Target number of participants: 106
Treatments
Experimental: Robot-assisted Kidney Transplantation (RAKT)
Participants will undergo standard work-up prior to transplantation according to the KDIGO guidelines, in addition, participation in the study will require a non-contrast CT of the abdomen to exclude severe calcification of the iliac vessels.~Participants will be managed according to the standard protocol for renal transplantation at Rigshospitalet and will follow standard pre-, peri- and post-operative care aside from operating modality. The anaestethic protocol will be tailored to suit robot-assisted surgery
Active_comparator: Open Kidney Transplantation (OKT)
Participants will undergo standard work-up prior to transplantation according to the KDIGO guidelines, in addition, participation in the study will require a non-contrast CT of the abdomen to exclude severe calcification of the iliac vessels.~Participants will be managed according to the standard protocol for anaesthesia and renal transplantation at Rigshospitalet and will follow standard pre-, peri- and post-operative care aside from operating modality.
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov