Clinical trial NCT02830568: Medical Economic Evaluation and of Quality of Life of the Kidney Living Donors.
Official title: Medical Economic Evaluation and of Quality of Life of the Kidney Living Donors. Comparison of the Taking of Kidney by cœliosurgery (Pure or " Hand-assisted "), by cœliosurgery Assisted by Robot and by the Classic Technique of Open Donor Nephrectomy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: Kidney transplantation
Surgical procedures
Kidney living donors
Quality of life
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 268
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Couples living donor - receiver of the services of urology and nephrology of 24 CHU in France practicing one of three techniques :

* Classic surgical taking by lombotomie : Besançon, Bicêtre, Caen, Lille, Marseille, Strasbourg, Tenon;
* Taking by coeliosurgery pure or hand-assisted : Clermont-Ferrand, Créteil, Foch, Grenoble, La Pitié Salpêtrière, Lyon Sud, Montpellier, Nantes, Necker,Saint-Etienne,Saint-Louis,Toulouse, Rouen;
* Coeliosurgical taking assisted by robot : Nancy, Nice, Lyon, Tours.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life of the donor
timeFrame: D-1 (day before nephrectomy), D4 (4 days after nephrectomy) and D90 (90 days after nephrectomy)
Secondary outcomes:
measure: Sociodemographic data
timeFrame: D-1, the day before nephrectomy
measure: Comfort, physical and mental investment of the surgeon measured by the Borg and the NASA-TLX scale
timeFrame: Day 0, the actual day of nephrectomy for each donor
measure: Biological values of the donor and the receiver
timeFrame: D-1 (day before nephrectomy), D2 (2 days after nephrectomy) D4 (4 days after nephrectomy) and D90 (90 days after nephrectomy)
measure: Treatments administered to the donor
timeFrame: D0 (the actual day of nephrectomy for each donor), D2 (2 days after nephrectomy), D4 (4 days after nephrectomy) and D90 (90 days after nephrectomy)
measure: Medical exams performed on the donor
timeFrame: D-1 (day before nephrectomy), D2 (2 days after nephrectomy) D4 (4 days after nephrectomy) and D90 (90 days after nephrectomy)
measure: Information on surgical technique employed to achieve nephrectomy and description of the graft.
timeFrame: Day 0, the actual day of nephrectomy for each donor
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Saint Jacques de Besançon
city: Caen
country: France
facility: CHU Côte de Nacre de CAEN
city: Clermont-ferrand
country: France
facility: CHU Montpied de Clermont-Ferrand
city: Creteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: CHU Hôpital Michallon de Grenoble
city: Le Kremlin Bicetre
country: France
facility: CHU Bicêtre
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Lyon
country: France
facility: CHU Lyon Sud
city: Lyon
country: France
facility: Hôpital Edouard Herriot de Lyon
city: Marseille
country: France
facility: CHU Hôpital de la Conception
city: Montpellier
country: France
facility: CHU Lapeyronie
city: Nancy
country: France
facility: CHU Brabois
city: Nantes
country: France
facility: CHU Hôtel Dieu
city: Nice
country: France
facility: CHU Pasteur
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Tenon
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Saint Etienne
country: France
facility: CHU Saint Etienne
city: Strasbourg
country: France
facility: CHU Hautepierre
city: Suresnes
country: France
facility: CMC Foch
city: Toulouse
country: France
facility: Hôpital de Rangueil
city: Tours
country: France
facility: CHU Bretonneau
Study officials:
References:
citation: Achit H, Guillemin F, Karam G, Ladriere M, Baumann C, Frimat L, Hosseini K, Hubert J. Cost-effectiveness of four living-donor nephrectomy techniques from a hospital perspective. Nephrol Dial Transplant. 2020 Nov 1;35(11):2004-2012. doi: 10.1093/ndt/gfz143.