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

NCT05730257 | Active Not Recruiting DMC

• 2 other identifiers: H-22065569P-2022-834
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

End Stage Renal Disease; Kidney Transplant; Complications

Keywords

Kidney Transplantation; Robotic Surgery

Outcome Measures

Primary Outcomes (2)

• Vascular complications

  Composite outcome consisting of a) bleeding requiring reoperation, b) renal/graft vascular thrombosis, c) symptomatic hematomas d) renal/graft arterial stenosis

  30 days after surgery

• Surgical complications Clavien-Dindo >grade 2

  All postoperative complications will be recorded and graded according to the Clavien-Dindo classification with major complications defined as \>grade 2.

  30 days after surgery

Secondary Outcomes (26)

• Length of Stay (LOS)

  12 months

• Days Alive and Out of Hospital (DAOH)

  30 days after surgery

• Days Alive and Out of Hospital (DAOH)

  90 days after surgery

• Quality of Life (QOL): SF-36

  30 days after surgery

• Quality of Life (QOL): SF-36

  90 days after surgery

Study Arms (2)

Robot-assisted Kidney Transplantation (RAKT)

EXPERIMENTAL

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

Procedure: Robot-Assisted Kidney Transplantation

Open Kidney Transplantation (OKT)

ACTIVE COMPARATOR

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.

Procedure: Open Kidney Transplantation

Interventions

Robot-Assisted Kidney Transplantation PROCEDURE

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.

Robot-assisted Kidney Transplantation (RAKT)

Open Kidney Transplantation PROCEDURE

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.

Open Kidney Transplantation (OKT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult recipients for renal transplantation
• Both patients in dialysis as well as pre-emptive

You may not qualify if:

• 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 or other relevant radiological imaging in recipient prior to transplantation
• Highly complex vascular anatomy in the donor kidney requiring multiple anastomoses as evaluated by surgeon
• Previous kidney transplantation with later allograft nephrectomy as evaluated by the surgeon preoperatively
• Patients 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 transplant
• Severe comorbidities contraindicating robot-assisted surgery
• Patients who are unable to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (2)

Urological Research Unit, Rigshospitalet

Copenhagen, N, 2200, Denmark

Location

Department of Nephrology, Rigshospitalet

Copenhagen, Ø, 2100, Denmark

Location

Related Publications (1)

• Ortved M, Dagnaes-Hansen J, Stroomberg HV, Kistorp T, Rohrsted M, Sorensen SS, Roder A. Open-label randomised clinical trial investigating whether robot-assisted kidney transplantation can reduce surgical complications compared to open kidney transplantation (ORAKTx): study protocol for a randomised clinical trial. Trials. 2025 Jan 6;26(1):8. doi: 10.1186/s13063-024-08706-5.

  PMID: 39762978 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Roeder, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 15, 2023
• Study Start: May 8, 2023
• Primary Completion: October 26, 2025
• Study Completion (Estimated): October 26, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)