Medical Economic Evaluation and of Quality of Life of the Kidney Living Donors.
Medical Economic Evaluation and of Quality of Life of the Kidney Living Donors.
The main objective of this multicentre study is to conduct the evaluation of cost-efficiency
 of various techniques of kidney taking with regard the quality of life of the kidney living
 donors.

 It will allow to compare three techniques of taking (open donor nephrectomy, cœliosurgery
 pure or " hand-assisted " and cœliosurgery assisted by robot) and to determine their
 respective advantages in quality of life, then their medico-economic consequences in a
 cost-efficiency approach from the point of view of the society.

 The evaluation will concern the donor and the receiver followed three months after the
 taking.

 The open donor nephrectomy will be the technique of reference with which will be compared the
 two others.
Context : The most efficient treatment of the terminal chronic renal insufficiency is the
 renal transplantation, but in spite of the realization of more than 2000 transplants a year
 in France, the waiting list increases every year in a important way. The decrease of the
 offer of transplants from deathly donors led numerous countries to develop the renal
 transplant from alive donors. This type of transplantation represents in 2007 only 8,1 % of
 transplants in France (report of ABM on 2007), but the deficit in renal transplants and the
 new laws of bioethics should increase this donation (it represents until 70 % of the renal
 transplantations in certain centres of North America or the Northern Europe).

 Although the French urology is at the top of the laparoscopic technique, the classic surgical
 taking by lombotomie stays the reference technique, practised by 58 % of the centres, with
 for the patient its consequences in terms of pain, of duration of hospitalization,
 convalescence and possible side effects. The development of the taking by cœliosurgery,
 mini-invasive technique, allowed to increase the number of wishes of organ donation in the
 centres which developed it. It is however a difficult technical gesture, requiring an
 important experience. This technique has the inconvenience of a more painful scar and more
 subject to complications than the section known pubic of "Pfannenstiel" used for the taking
 by pure cœliosurgery.

 The surgical robot Da Vinci (Intuitive Surgical, Sunnyvale, California), with a 3D mink, the
 joints of the instruments inside the body, the reduction of the movements, the best
 ergonomics, improves the precision of the cœlioscopic gesture, but has a sharply upper cost.
 The CHU of Nancy was the pioneer in Europe to develop this technique from 2002, with very
 encouraging results on a series from now on more than 80 patients.

 Only retrospective studies compared the quality of life between these techniques, and in
 spite of the major financial impacts (10 years of dialysis represent 100 K€; the price of the
 robot is of 1700 K€) and the important differences of quality of life according to these
 various surgical approaches, no prospective comparative medico-economic study was realized up
 to now. In France, where the hospital bears the load of all the expenses concerning the
 donor, including its daily allowances during its medical certificate, the shortening of the
 hospitalization and of the convalescence of the donor as well as the results improved by the
 transplantation at the receiver of a kidney living donor would allow a fast amortization of
 these expensive technologies.

 Main objective : To compare the cost and the efficiency of the three techniques of taking of
 kidney living donor.

 Main assessment criterion : The quality of life of the donor tested by generic measuring
 instruments EUROQOL and SF-36 (both to D-1 (the day before the renal transplantation), D4 (4
 days after) and D90 (3 months after) and SF-36 to D-1 and D90). It will be realized at the
 donor's in preoperative (D-1), in postoperative (D4) and in the visit of follow-up in 3
 months (D90). It will be also collected at the receiver's in preoperative (D-1),
 postoperative immediate (D4) and in the visit of follow-up in 3 months (D90).

 The combination with the cost estimate will allow to build the marginal cost-efficiency
 ratio.

 Secondary objectives envisaged:

 -  The evaluation of the quality of life of the receiver by measuring instrument becomes
 generic EUROQOL and SF-36 to D-1, D4 (only Euroqol) and D90.

 -  The comparison of the comfort of the surgeon and his physical and psychic investment by
 index card(form) of specific evaluation (Borg and NASA-TLX).

 -  The comparison of the coelio-surgical techniques : pure coelioscopy, coelioscopy "
 hand-assisted " and coelioscopy assisted by robot will concern the quality of life and
 the marginal cost-efficiency ratio.
Inclusion Criteria:

 -  The receiver is registered on the ABM list;

 -  The receiver is on dialysis or in preterminal renal insufficiency;

 -  The donor is a member of the circle of acquaintances of the receiver.

 Exclusion Criteria:

 -  Risk of difficulties of follow-up during 3 months following the transplant (ex:
 patient not living in France);

 -  Refusal of participation of the donor.