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

Kidney Transplantation Clinical Trial

— DOVIREIN  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830568
• Other study ID #: 10.039
• Status: Completed
• Phase: N/A
• First received: June 7, 2010
• Last updated: July 8, 2016
• Start date: June 2010
• Est. completion date: July 2013

Study information

• Verified date: May 2010
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Procedure:
• open donor nephrectomy
open donor nephrectomy
• standard and hand-assisted laparoscopic donor nephrectomy
standard and hand-assisted laparoscopic donor nephrectomy
• laparoscopic robotic-assisted nephrectomy
laparoscopic robotic-assisted nephrectomy

Locations

Country	Name	City	State
France	CHU Saint Jacques de Besançon	Besancon
France	CHU Côte de Nacre de CAEN	Caen
France	CHU Montpied de Clermont-Ferrand	Clermont-ferrand
France	CHU Henri Mondor	Creteil
France	CHU Hôpital Michallon de Grenoble	Grenoble
France	CHU Bicêtre	Le Kremlin Bicetre
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

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life of the donor	Quality of life of the donor as measured by EUROQOL (score 0 to 1) and SF 36 self-administered questionnaires (score 0 to 100 in each of 8 dimensions , at D-1 (the day before nephrectomy), D4 (4 days after nephrectomy) and D90 (90 days after nephrectomy).; biological values of the donor and the receiver	D-1 (day before nephrectomy), D4 (4 days after nephrectomy) and D90 (90 days after nephrectomy)	No
Secondary	Sociodemographic data	At D-1 (the day before nephrectomy), sociodemographic data are collected	D-1, the day before nephrectomy	No
Secondary	Comfort, physical and mental investment of the surgeon measured by the Borg and the NASA-TLX scale	The Borg scale consists of 7 questions corresponding to the level of discomfort in 7 body segments of the surgeon with responses ranging from 0 (no discomfort) to 10 (very very strong discomfort). The surgeon is questioned every 30 minutes during the surgery. The NASA-TLX scale consists in 8 questions about physical and mental investment with responses ranging from 0 (low) to 100 (high). The surgeon completes this scale immediately at the end of the surgical procedure.	Day 0, the actual day of nephrectomy for each donor	No
Secondary	Biological values of the donor and the receiver	Blood count and serum electrolyte levels are collected. biological values of the donor and the receiver	D-1 (day before nephrectomy), D2 (2 days after nephrectomy) D4 (4 days after nephrectomy) and D90 (90 days after nephrectomy)	No
Secondary	Treatments administered to the donor	Treatments administered to the donor from D0 (the actual day of nephrectomy for each donor) to D90 (90 days after nephrectomy).	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)	No
Secondary	Medical exams performed on the donor	Medical exams performed on the donor from D0 (the actual day of nephrectomy for each donor) to D90 (90 days after nephrectomy).	D-1 (day before nephrectomy), D2 (2 days after nephrectomy) D4 (4 days after nephrectomy) and D90 (90 days after nephrectomy)	No
Secondary	Information on surgical technique employed to achieve nephrectomy and description of the graft.	Type of surgery (open donor nephrectomy, standard or hand-assisted laparoscopic donor nephrectomyor laparoscopic robotic-assisted nephrectomy), Duration of surgery and of ischemia and description of the graft.	Day 0, the actual day of nephrectomy for each donor	No