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

8. července 2016 aktualizováno: Central Hospital, Nancy, France

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.

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

268

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Francie
      • Besancon, Francie, 25030
        • CHU Saint Jacques de Besançon
      • Caen, Francie, 14000
        • CHU Côte de Nacre de CAEN
      • Clermont-ferrand, Francie, 63003
        • CHU Montpied de Clermont-Ferrand
      • Creteil, Francie, 94010
        • CHU Henri Mondor
      • Grenoble, Francie, 38043
        • CHU Hôpital Michallon de Grenoble
      • Le Kremlin Bicetre, Francie, 94275
        • CHU Bicetre
      • Lille, Francie, 59000
        • Hopital Claude Huriez
      • Lyon, Francie, 69000
        • CHU Lyon Sud
      • Lyon, Francie, 69437
        • Hôpital Edouard Herriot de Lyon
      • Marseille, Francie, 13274
        • CHU Hôpital de la Conception
      • Montpellier, Francie, 34295
        • CHU Lapeyronie
      • Nancy, Francie, 54000
        • CHU Brabois
      • Nantes, Francie, 44093
        • Chu Hotel Dieu
      • Nice, Francie, 06002
        • CHU Pasteur
      • Paris, Francie, 75970
        • Hopital Tenon
      • Paris, Francie, 75651
        • Hôpital Pitie Salpétrière
      • Paris, Francie, 75015
        • Hôpital Necker
      • Paris, Francie, 75970
        • Hôpital Saint-Louis
      • Rouen, Francie, 76038
        • Hôpital Charles Nicolle
      • Saint Etienne, Francie, 42000
        • CHU Saint Etienne
      • Strasbourg, Francie, 67091
        • CHU Hautepierre
      • Suresnes, Francie, 92151
        • CMC Foch
      • Toulouse, Francie, 31059
        • Hopital de Rangueil
      • Tours, Francie, 37000
        • CHU Bretonneau

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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
Postup: open donor nephrectomy
open donor nephrectomy
Postup: standard and hand-assisted laparoscopic donor nephrectomy
standard and hand-assisted laparoscopic donor nephrectomy
Postup: laparoscopic robotic-assisted nephrectomy
laparoscopic robotic-assisted nephrectomy

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Quality of life of the donor
Časové okno: D-1 (day before nephrectomy), D4 (4 days after nephrectomy) and D90 (90 days after nephrectomy)

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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sociodemographic data
Časové okno: D-1, the day before nephrectomy
At D-1 (the day before nephrectomy), sociodemographic data are collected
D-1, the day before nephrectomy
Comfort, physical and mental investment of the surgeon measured by the Borg and the NASA-TLX scale
Časové okno: Day 0, the actual day of nephrectomy for each donor
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
Biological values of the donor and the receiver
Časové okno: D-1 (day before nephrectomy), D2 (2 days after nephrectomy) D4 (4 days after nephrectomy) and D90 (90 days after nephrectomy)
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)
Treatments administered to the donor
Časové okno: 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)
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)
Medical exams performed on the donor
Časové okno: D-1 (day before nephrectomy), D2 (2 days after nephrectomy) D4 (4 days after nephrectomy) and D90 (90 days after nephrectomy)
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)
Information on surgical technique employed to achieve nephrectomy and description of the graft.
Časové okno: Day 0, the actual day of nephrectomy for each donor
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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Central Hospital, Nancy, France

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. června 2010

Primární dokončení (Aktuální)

1. července 2013

Dokončení studie (Aktuální)

1. července 2013

Termíny zápisu do studia

První předloženo

7. června 2010

První předloženo, které splnilo kritéria kontroly kvality

8. července 2016

První zveřejněno (Odhad)

13. července 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

13. července 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. července 2016

Naposledy ověřeno

1. května 2010

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 10.039

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