Medical Economic Evaluation and of Quality of Life of the Kidney Living Donors.
DOVIREIN
1 other identifier
observational
268
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedJuly 13, 2016
May 1, 2010
3.1 years
June 7, 2010
July 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (6)
Sociodemographic data
D-1, the day before nephrectomy
Comfort, physical and mental investment of the surgeon measured by the Borg and the NASA-TLX scale
Day 0, the actual day of nephrectomy for each donor
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)
Treatments administered to the donor
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)
Medical exams performed on the donor
D-1 (day before nephrectomy), D2 (2 days after nephrectomy) D4 (4 days after nephrectomy) and D90 (90 days after nephrectomy)
- +1 more secondary outcomes
Study Arms (1)
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
Interventions
standard and hand-assisted laparoscopic donor nephrectomy
laparoscopic robotic-assisted nephrectomy
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Risk of difficulties of follow-up during 3 months following the transplant (ex: patient not living in France);
- Refusal of participation of the donor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
CHU Saint Jacques de Besançon
Besançon, 25030, France
CHU Côte de Nacre de CAEN
Caen, 14000, France
CHU Montpied de Clermont-Ferrand
Clermont-Ferrand, 63003, France
CHU Henri Mondor
Créteil, 94010, France
CHU Hôpital Michallon de Grenoble
Grenoble, 38043, France
CHU Bicêtre
Le Kremlin-Bicêtre, 94275, France
Hôpital Claude Huriez
Lille, 59000, France
CHU Lyon Sud
Lyon, 69000, France
Hôpital Edouard Herriot de Lyon
Lyon, 69437, France
CHU Hôpital de la Conception
Marseille, 13274, France
CHU Lapeyronie
Montpellier, 34295, France
CHU Brabois
Nancy, 54000, France
CHU Hôtel Dieu
Nantes, 44093, France
CHU Pasteur
Nice, 06002, France
Hôpital Necker
Paris, 75015, France
Hôpital Pitié Salpêtrière
Paris, 75651, France
Hôpital Saint-Louis
Paris, 75970, France
Hôpital Tenon
Paris, 75970, France
Hôpital Charles Nicolle
Rouen, 76038, France
CHU Saint Etienne
Saint-Etienne, 42000, France
CHU Hautepierre
Strasbourg, 67091, France
CMC Foch
Suresnes, 92151, France
Hôpital de Rangueil
Toulouse, 31059, France
CHU Bretonneau
Tours, 37000, France
Related Publications (1)
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.
PMID: 31377771DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2010
First Posted
July 13, 2016
Study Start
June 1, 2010
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 13, 2016
Record last verified: 2010-05