Study Investigating Whether Robot-assisted Surgery Can Reduce Surgical Complications Following Kidney Transplantation

Condition(s) studied

Investigational drug(s) / intervention(s)

Robot-Assisted Kidney Transplantation: Robot-Assisted Kidney Transplantation takes place with the patient under general anaesthesia. Several ports are placed in the lower abdomen, for the entry of the camera, surgical instruments and manuel access. The DaVinci robot is placed between the patient's legs and docked to the ports. The iliac vascular bed is prepared and a peritoneal cavity created laterally. The kidney is introduced through the handport, regional hypothermia obtained via iceslush in the cavity and the vessel lumens flushed with heparin. The vessels are blocked during suturing with the kidney graft vessels anastomosed end-to-side to the external iliac vessels. The kidney graft is placed in the retroperitoneal cavity and a ureterovesical anastomosis performed ad modem Woodruff over double J stent. The ureter is placed extra peritoneally, fascia closed in layers and the skin using intracutaneous suturing. Perioperative prophylactics entail piperacillin/tazobactam and an indwelling bladder catheter is placed.

Open Kidney Transplantation: Open Kidney Transplantation takes place with the patient under general anaesthesia. A jockey-stick (Gibson) incision is made in the left or right iliac fossa and the peritoneum is displaced. With the kidney under hypothermia, the iliac vascular bed is prepared, the vessel lumens flushed with heparin and a vascular clamp instrument is used to block the vessels during suturing. The kidney graft vessels are anastomosed end-to-side to the external iliac vessels and the ureterovesical anastomosis performed ad modem Woodruff over a double J stent. The kidney graft is placed in the cavity and the fascia is closed in layers and the skin using intracutaneous suturing. Perioperative prophylactics entail piperacillin/tazobactam and an indwelling bladder catheter is placed.

Study 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

Primary outcome measure(s)

• Vascular complications — 30 days after surgery
  Composite outcome consisting of a) bleeding requiring reoperation, b) renal/graft vascular thrombosis, c) symptomatic hematomas d) renal/graft arterial stenosis
• Surgical complications Clavien-Dindo >grade 2 — 30 days after surgery
  All postoperative complications will be recorded and graded according to the Clavien-Dindo classification with major complications defined as \>grade 2.

Trial sites (2)

Other trials for the same condition