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

8. Juli 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

268

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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
Verfahren: open donor nephrectomy
open donor nephrectomy
Verfahren: standard and hand-assisted laparoscopic donor nephrectomy
standard and hand-assisted laparoscopic donor nephrectomy
Verfahren: laparoscopic robotic-assisted nephrectomy
laparoscopic robotic-assisted nephrectomy

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Quality of life of the donor
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sociodemographic data
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Central Hospital, Nancy, France

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2010

Primärer Abschluss (Tatsächlich)

1. Juli 2013

Studienabschluss (Tatsächlich)

1. Juli 2013

Studienanmeldedaten

Zuerst eingereicht

7. Juni 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juli 2016

Zuerst gepostet (Schätzen)

13. Juli 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

13. Juli 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juli 2016

Zuletzt verifiziert

1. Mai 2010

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 10.039

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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