Franny Jongbloed

182 CHAPTER 7 high percentage of dropouts. Ensuring that the patients fast overnight before blood is drawn will increase the sample size and the potential value of the study. Finally, a larger sample size is needed in order to validate the results of this study and to investigate the effects of a diet comprising DR and PR on perioperative and postoperative responses. Although safety was not an outcome measure, we have carefully monitored the patients’ peri- and postoperative course in the present study, and have observed no differences in type and rate of complications and length of hospital stay between the three study groups. In conclusion, our results show that a diet comprising DR and PR is feasible in both living kidney donors and in morbidly obese patients awaiting surgery. This restricted diet was easily instituted and adherence to the diet could be measured objectively using a combination of laboratory parameters. Minor adaptations to the diet, such as increasing the amount of non-liquid food during the diet, could lead to an even higher compliance rate and to decreased discomfort. This short-term dietary intervention is feasible and ready for further investigation of the effects of DR on perioperative and postoperative responses in a clinical setting. SUBJECTS AND METHODS Study design This pilot study was designed as a prospective multicenter pilot study. The study was approved by the Medical Ethics Committee (METC, MEC number 2012-134) of the Erasmus University Medical Center, Rotterdam, The Netherlands, and by the Board of Directors of the Maasstad Hospital, Rotterdam, The Netherlands. The study procedures were in accordance with the METC guidelines. The trial is registered as the PROTECT trial in the Dutch trial registry database using trial code 3663 (www.trialregister.nl) . This manuscript was prepared in accordance with the CONSORT 2010 statement 27 , according to the Declaration of Helsinki. Inclusion and exclusion criteria The coordinating investigator approached patients at the hospitals’ outpatient clinic during their scheduled doctor appointments. All patients included in the study gave written informed consent to participate. Patients were informed that this study only aimed to establish the feasibility of the diet in surgical patients. Apatient flowchart showing inclusions/ exclusions and randomization procedures is depicted in Figure S3.