Quality of Life After Randomization to Laparoscopic Versus Open Living Donor Nephrectomy: Long-Term Follow-Up Marit Helen Andersen, 1,2,8 Lars Mathisen, 3 Marijke Veenstra, 4 Ole Øyen, 1 Bjørn Edwin, 1,2 Randi Digernes, 5 Gunnvald Kvarstein, 5 Tor Inge Tønnessen, 2,5,6 Astrid Klopstad Wahl, 7 Berit Rokne Hanestad, 7 and Erik Fosse 2,6 Background. The aim of this randomized study was to compare patient-reported outcome after laparoscopic versus open donor nephrectomy during 1 year follow-up. The evidence base has so far not allowed for a decision as to which method is superior as seen from a long-term quality of life-perspective. Methods. The donors were randomized to laparoscopic (n=63) or open (n=59) nephrectomy, with follow-up at 1, 6, and 12 months. Primary outcomes were health status (SF-36) and overall quality of life (QOLS-N). Secondary out- comes were donor perception of the surgical scar, the donation’s impact on personal finances, and whether the donor would make the same decision to donate again. Results. There was a significant difference in favor of laparoscopic surgery regarding the SF-36 subscale bodily pain at 1 month postoperatively (P0.05). Analysis based on intention to treat revealed no long-term differences between groups in SF-36 scores. When subtracting the reoperated/converted donors of the laparoscopic group, significant differences in favor of laparoscopy were revealed in the subscales bodily pain at 6 months (P0.05) and social func- tioning at 12 months (P0.05). No significant differences were found in QOLS-N scores between groups. Conclusions. Laparoscopic donor nephrectomy is an attractive alternative to open donor nephrectomy because of less postoperative pain. However, long-term comparison only revealed significant differences in favor of laparoscopy when adjusting for reoperations/conversions. Both groups reached baseline scores in most SF-36 subscales at 12 months and this may explain why possible minor benefits are hard to prove. Keywords: Living donor nephrectomy, Laparoscopy, Quality of life, Long-term follow-up. (Transplantation 2007;84: 64–69) T here is worldwide an increasing use of living kidney do- nors in renal transplantation (1). In Norway, living do- nors account for almost 40% of all renal transplantations (2). The kidney has conventionally been removed by open tech- nique through a flank incision (in some centers including rib resection). Thus, open nephrectomy has been considered a major trauma for living kidney donors, causing pain and dis- comfort in the postoperative period (3). In an effort to re- move some of these disincentives, Ratner et al. (4) performed the first laparoscopic live donor nephrectomy in 1995. At our single national center in Norway, open nephrectomy has been the established procedure, but since 1998 laparascopic donor nephrectomy has been performed in selected donors. In 2000, an Australian research group performed a systematic litera- ture review of laparoscopic and open living donor nephrec- tomy and concluded that the evidence base was inadequate to make recommendations regarding surgical technique (5). On this background, we performed the largest randomized qual- ity of life study so far by assigning 122 donors to laparoscopic or open surgery. The first reports from this study have been published, focusing on donor safety (6) and postoperative pain and convalescence (7). To allow for the donors’ subjec- tive assessment of going through laparoscopic or open donor nephrectomy, we performed a long-term comparison of health status and overall quality of life at 1, 6, and 12 months after surgery. In the present study health status included the donors’ perception of functioning, disability, and well-being related to the following eight concepts: physical functioning, role limitations caused by physical health problems, bodily pain, general health, vitality, social functioning, role limita- tion caused by emotional problems, and mental health (8). Overall quality of life was defined as a person’s well-being that stems from satisfaction or dissatisfaction with areas that are important to him or her (9). MATERIALS AND METHODS Patients During initial evaluation for donation, consecutive donors were asked to participate in the study by local neph- rologists throughout the country. Potential donors fulfilling 1 Department of Surgery, Rikshospitalet-Radiumhospitalet Medical Centre, Oslo, Norway. 2 The Interventional Centre, Rikshospitalet-Radiumhospitalet Medical Cen- tre, Oslo, Norway. 3 Department of Thoracic and Cardiovascular Surgery, Rikshospitalet- Radiumhospitalet Medical Centre, Oslo, Norway. 4 Department of Biostatistics, Rikshospitalet-Radiumhospitalet Medical Centre, Oslo, Norway. 5 Department of Anesthesiology, Rikshospitalet-Radiumhospitalet Medical Centre, Oslo, Norway. 6 University of Oslo, Oslo, Norway. 7 Department of Public Health and Primary Health Care, University of Ber- gen, Bergen, Norway. 8 Address correspondence to: Marit Helen Andersen, RN., Cand. polit., Depart- ment of Surgery/The Interventional Centre, Rikshospitalet-Radiumhospitalet Medical Centre, 0027 Oslo, Norway. E-mail: marit.andersen@rikshospitalet.no Received 12 February 2007. Revision requested 27 March 2007. Accepted 12 April 2007. Copyright © 2007 by Lippincott Williams & Wilkins ISSN 0041-1337/07/8401-64 DOI: 10.1097/01.tp.0000268071.63977.42 64 Transplantation • Volume 84, Number 1, July 15, 2007