Donatie - P56 - Towards a standardized informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Eva­luation) project: study protocol for a nationwide prospective cohort study

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K. Kortram, E.Q.W. Spoon, S.Y. Ismail, F.A. d'Ancona, M. Christiaans, L.W.E. van Heurn, S. Hofker, A.W.J. Hoksbergen, J.J. Homan van der Heide, M.M. Idu, C.W.N. Looman, A. Nurmohamed, J. Ringers, R.J. Toorop, J. van de Wetering, J.N.M Ijzermans, F.J.M.F. Dor

Chair(s): drs. Tineke Wind, transplantatiecoördinator, Maastricht UMC

Thursday 10 march 2016

13:00 - 13:30h at Foyer

Categories: Postersessie

Parallel session: Postersessies XI - Opgesplitst in 3 tijdblokken en 3 categoriëen (klinisch, basaal, donatie)

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Background: 
A recent systematic review demonstrated that there is no consensus on how the informed consent procedure in live donor nephrectomy should be arranged and practices vary. The aim of this survey study was to evaluate the surgical informed consent procedure for live donor nephrectomy, with special regards to disclosed complications.

Methods:
A web-based survey was sent to all surgeons in the Netherlands who were believed to be, or had been in the past, involved in live kidney donation (n=50). Surgeons were asked if, and how often they mentioned 23 items regarding short- and long-term complications. In addition, questions were included regarding the informed consent practices in each transplant center. Center- and surgeon characteristics (e.g. center volume, surgeons' gender, specialization, experience) were compared to assess whether information disclosure was related to any of these features.

Results: 
The response rate was 98% (N=49), and responses were obtained from all eight kidney transplant centers. Of these 49 respondents, 32 were still involved in living kidney donor education. Surgeons had the following subspecializations: transplant surgery (50%), vascular surgery (31%), abdominal surgery (13%), and urology (6%). Informed consent procedures vary between centers, ranging from assumed to signed consent. Some respondents from the same center report different procedures. Bleeding was the only complication every surgeon mentioned. Risk of death was always mentioned by 16 surgeons (50%), sometimes by 12 (37.5%), four surgeons (12.5%) never disclosed this disastrous complication. Reported mortality rates ranged from 0.003% to 0.1%. Mentioning frequencies for all other complications varied per individual surgeon, but also per center. High volume surgeons reported more complications than low volume surgeons. The risk of postoperative pain was more often disclosed by consultant surgeons than fellows, and the risk of death was more often disclosed by surgeons with a differentiation in transplant surgery.

Conclusion:
Important complications are not always disclosed during the surgical informed consent process for live donor nephrectomy. Informed consent procedures vary. To optimally prepare living kidney donors for the procedure, a standardized informed consent procedure for live donor nephrectomy is highly recommended.