Medical Economic Evaluation and of Quality of Life of the Kidney Living Donors.

NCT ID: NCT02830568

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 268 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-07-31

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.

Conditions

Kidney Transplantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

couples kidney living donor - receiver

Three groups for each technique of taking of kidney :

1. open donor nephrectomy

2. standard and hand-assisted laparoscopic donor nephrectomy

3. laparoscopic robotic-assisted nephrectomy

open donor nephrectomy

Intervention Type: PROCEDURE

open donor nephrectomy

standard and hand-assisted laparoscopic donor nephrectomy

Intervention Type: PROCEDURE

standard and hand-assisted laparoscopic donor nephrectomy

laparoscopic robotic-assisted nephrectomy

Intervention Type: PROCEDURE

laparoscopic robotic-assisted nephrectomy

Interventions

open donor nephrectomy

open donor nephrectomy

Intervention Type: PROCEDURE

standard and hand-assisted laparoscopic donor nephrectomy

standard and hand-assisted laparoscopic donor nephrectomy

Intervention Type: PROCEDURE

laparoscopic robotic-assisted nephrectomy

laparoscopic robotic-assisted nephrectomy

Intervention Type: PROCEDURE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Saint Jacques de Besançon

Besançon, , France

CHU Côte de Nacre de CAEN

Caen, , France

CHU Montpied de Clermont-Ferrand

Clermont-Ferrand, , France

CHU Henri Mondor

Créteil, , France

CHU Hôpital Michallon de Grenoble

Grenoble, , France

CHU Bicêtre

Le Kremlin-Bicêtre, , France

Hôpital Claude Huriez

Lille, , France

CHU Lyon Sud

Lyon, , France

Hôpital Edouard Herriot de Lyon

Lyon, , France

CHU Hôpital de la Conception

Marseille, , France

CHU Lapeyronie

Montpellier, , France

CHU Brabois

Nancy, , France

CHU Hôtel Dieu

Nantes, , France

CHU Pasteur

Nice, , France

Hôpital Necker

Paris, , France

Hôpital Pitié Salpêtrière

Paris, , France

Hôpital Saint-Louis

Paris, , France

Hôpital Tenon

Paris, , France

Hôpital Charles Nicolle

Rouen, , France

CHU Saint Etienne

Saint-Etienne, , France

CHU Hautepierre

Strasbourg, , France

CMC Foch

Suresnes, , France

Hôpital de Rangueil

Toulouse, , France

CHU Bretonneau

Tours, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 31377771 (View on PubMed)

Other Identifiers

10.039

Identifier Type: -

Identifier Source: org_study_id