Clinical trial NCT05730257: Study Investigating Whether Robot-assisted Surgery Can Reduce Surgical Complications Following Kidney Transplantation
Official title: Open-label Randomized Clinical Trial Investigating Whether Robot-Assisted Kidney Transplantation Can Reduce Surgical Complications Compared to Open Kidney Transplantation; The ORAKTx Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Kidney Transplant; Complications
Keywords: Kidney Transplantation
Robotic Surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Kidney transplantation is the ultimate surgical treatment for end stage renal disease, and while medical transplantation therapy has developed tremendously and now allows for transplantation and long-term survival, even in seemingly incompatible donors and recipients, kidney graft survival still, to a large extent, depends on a smooth and complication-free surgical procedure. In the past decade surgical techniques have been expanded by the introduction of surgical robots to improve minimally invasive surgery and optimize post-surgical care. Previous studies suggest that robot-assisted surgery has the potential to reduce complications such as surgical site infection and blood-loss, facilitate fast-track or even ambulatory surgery for complicated procedures and recent studies suggest this may be the case for kidney transplantation too.

The aim of this trial is therefore to explore if robot-assisted surgery can reduce surgical complications following kidney transplantation compared to open surgery (standard of care) and investigate the patient trajectory following the two procedures in terms of late complications, graft function and mortality. The study design is a superiority, open-label randomized clinical trial to be conducted at Rigshospitalet, the largest transplantation centre in Denmark.

The primary outcomes consist of 1) reduction in vascular complications (graft arterial stenosis, bleeding requiring reoperation, symptomatic haematomas, renal vascular thrombosis). The rate of vascular complications is currently 17.3%. With a power set at 80% and a significance level set at 5% we hypothesize that Robot-Assisted Kidney Transplantation (RAKT) can reduce vascular complications by 15% within 30 days after transplantation compared to Open Kidney Transplantation (OKT). 2) Reduction in surgical complications Clavien-Dindo \> grade 2. The rate of Clavien-Dindo \>2 is currently 22.8%.

With a power set at 80% and a significance level set at 5%, we hypothesize that RAKT can reduce Clavien-Dindo \>2 by 20% within 30 days after transplantation compared to OKT.

The study will randomize 106 participants with an anticipated drop-out of 10% (n=96). Immediate follow-up will be 30-days after kidney transplantation to observe occurrence of primary endpoints assessed by chart review including both in- and out-patient information. Follow-up through chart review will persist for 2 years in order to monitor long-term complications and assess secondary outcomes. Participants will be randomized with a 1:1 allocation ratio using the randomization module in REDCap with differing block sizes. Dropouts will be replaced by the same randomization number to ensure equal distribution.

The study is analysed as intention-to-treat. The primary endpoints are expected to be evaluated as percent of patients with complications compared between the two groups. Secondary outcomes will be represented descriptively and analysed according to the datatype. An interim analysis will be performed when 50% of the patients are enrolled in the study. Statistical analysis will be undertaken using R version 3.2 or later if available.

While robot-assisted kidney transplantation is still in its experimental phase, robot-assisted surgery is not and many urological procedures use robotic assistance with excellent results. With no randomized clinical trials to date comparing RAKT to OKT, this study aims to contribute with valuable evidence on the possible benefits of RAKT for both surgical outcomes and the post-operative and long-term patient trajectory.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion 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 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

Primary outcomes:
measure: Vascular complications
timeFrame: 30 days after surgery
measure: Surgical complications Clavien-Dindo >grade 2
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Length of Stay (LOS)
timeFrame: 12 months
measure: Days Alive and Out of Hospital (DAOH)
timeFrame: 30 days after surgery
measure: Days Alive and Out of Hospital (DAOH)
timeFrame: 90 days after surgery
measure: Quality of Life (QOL): SF-36
timeFrame: 30 days after surgery
measure: Quality of Life (QOL): SF-36
timeFrame: 90 days after surgery
measure: Use of analgesics
timeFrame: 12 months
measure: Transfusion rate
timeFrame: 30 days after surgery
measure: Kidney Function
timeFrame: 30 days after surgery
measure: Kidney Function
timeFrame: 90 days after surgery
measure: Kidney Function
timeFrame: 12 months after surgery
measure: Kidney Function
timeFrame: 24 months after surgery
measure: Delayed Graft Function (DGF)
timeFrame: 7 days after surgery
measure: Graft loss
timeFrame: 30 days after surgery
measure: Graft loss
timeFrame: 90 days after surgery
measure: Graft loss
timeFrame: 24 months after surgery
measure: 30-day Mortality
timeFrame: 30 days after surgery
measure: 90-day Mortality
timeFrame: 90 days after surgery
measure: 1-year Mortality
timeFrame: 12 months after surgery
measure: 2-year Mortality
timeFrame: 24 months after surgery
measure: Specific urological surgical complications
timeFrame: 30 days after surgery
measure: Late & specific urological surgical complications
timeFrame: 90 days after surgery
measure: Late & specific urological surgical complications
timeFrame: 24 months after surgery
measure: Time to return to work
timeFrame: 90 days after surgery
measure: Recurrent urinary tract infection (UTI)
timeFrame: 90 days after surgery
measure: Recurrent urinary tract infection (UTI)
timeFrame: 24 months after surgery
measure: Rejection
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Urological Research Unit, Rigshospitalet
state: N
city: Copenhagen
country: Denmark
facility: Department of Nephrology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Andreas Roeder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: