|- candidate number||13392|
|- NTR Number||NTR3658|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-okt-2012|
|- Secondary IDs||MEC-2011-344 METC EMC|
|- Public Title||In beeld brengen, vrijleggen en doornemen van de bloedvaten bij nierdonatie met behulp van een robot-geassisteerde techniek.|
|- Scientific Title||Visualisation and dissection during the hilar phase in robotic-assisted donor nephrectomy.|
|- hypothesis||The robotic-assisted technique will allow the ascertainment of ‘Critical View of Safety’ in all anatomical variations. |
|- Healt Condition(s) or Problem(s) studied||Robotic-assisted donor nephrectomy|
|- Inclusion criteria||All, properly Dutch speaking, live kidney donors who are medically capable of donating one of their kidneys can be included in the RODO-trial. Informed consent is mandatory. All types of live kidney donors can participate in the study i.e. related, unrelated, altruistic and cross-over live kidney donors.|
|- Exclusion criteria||Exclusion criteria are a history of kidney surgery or adrenal gland surgery on the side chosen for surgery.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||23-jan-2012|
|- planned closingdate||23-jan-2014|
|- Target number of participants||40|
|- Interventions||Robotic-assisted donor nephrectomy.|
|- Primary outcome||Efficacy of the process of the adapted ‘Critical View of Safety” and ‘Hierarchical Task Analysis’. |
|- Secondary outcome||1. Skin-to-skin time;|
2. Warm ischemia time;
4. Per-operative complications;
5. Post-operative complications;
6. Quality of life.
|- Timepoints||End of follow-up: Three months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| K.W.J. Klop|
|- CONTACT for SCIENTIFIC QUERIES|| K.W.J. Klop|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||Kidney transplantation is the only treatment offering long-term benefit to patients with chronic kidney failure. In the last decade a huge increase in the use of living donors has been realized for kidney transplantation. However, with it’s increasing use, serious complications become more common, including procedure related mortality. In order to guarantee safety for the donor, it is important to optimise the surgical approach.
The criteria for live kidney donation have extended, leading to the eligibility of obese and elderly donors, but also donors with a complex anatomy. During laparoscopic donor nephrectomy (LDN), dissection of the renal hilum may be more difficult in case of a complex anatomy. During the robotic-assisted donor nephrectomy, the surgeon operates from a seated position at a console. To move the instruments or to reposition the 3D camera, the surgeon simply moves the hands, using multifunctional joysticks. Surgeons will be provided with superior 3D visualization, enhanced dexterity because of an enhanced rotation angle of the robotic wrists (540º vs. 180º in case of laparoscopic instruments being moved by human hands), greater precision and ergonomic comfort. The Da Vinci Surgical System makes it possible for more surgeons to perform minimally invasive procedures involving complex dissection, optimising safety for all living donors.
LDN can cause pain in wrests, elbows, shoulder and neck. When a surgeon experiences discomfort during surgery, it may impede concentration and dissection. Especially in cases where dissection is more difficult, as is the case with complex anatomy, discomfort may increase. The benefits of operating in a seated position may lead to increased safety in these cases and increased comfort for surgeons.
The Erasmus Medical Center has the largest live kidney donation programme in Europe; therefore we feel it is also our responsibility to keep exploring any new developments in this field. The robotic-assisted donor nephrectomy is already accepted and performed in many transplantation centers across the United States of America. However, this popularity may be commercially driven and so far no prospective trials on safety regarding this technique have been published. In this era of evidence based medicine it is not only in the interest of the Dutch research field, but of global interest to fill this void in our knowledge.
For live kidney donors, a robotic-assisted procedure may offer all the potential benefits of a minimally invasive procedure, while safety might be increased. This may especially be the case in donors with complex anatomy and a higher BMI. In an era where treatments are chosen on patient characteristics, the robotic assisted donor nephrectomy may be a valuable addition to the surgical arsenal. Furthermore, this project will help to inform potential donors properly on the advantages of different operative techniques. However, to date no prospective studies have been reported to demonstrate the benefit of robotic-assisted approach.
|- Main changes (audit trail)|
|- RECORD||2-okt-2012 - 22-okt-2012|