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NDT Advance Access published online on August 18, 2008
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfn463
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© The Author [2008]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org


How safe is hand-assisted laparoscopic donor nephrectomy?—Results of 200 live donor nephrectomies by two different techniques

Pankaj Chandak, Nicos Kessaris, Ben Challacombe, Jonathan Olsburgh, Francis Calder and Nizam Mamode

Department of Transplant Surgery, Renal Unit, Guy's Hospital, Guy's and St. Thomas’ NHS Trust, London, UK

Correspondence and offprint requests to: Nizam Mamode, 6th floor Renal Unit, New Guy's House, Guy's Hospital, London Bridge, London, UK. Tel: +44-02071881543; E-mail: nizam{at}mamode.co.uk



   Abstract
Top
 Abstract
Introduction
 Patients and methods
 Results
 Discussion
 References
 
Background. Despite the rapid introduction of laparoscopic living donor nephrectomy, doubts exist about safety compared with open surgery. Early series have often reported on selective donor groups. We present a consecutive, prospective analysis of morbidity following hand-assisted laparoscopic donor nephrectomy (HALDN) compared with historical controls undergoing open donation (ODN) in a total of 200 living donors at a single UK centre.

Methods. The results of 144 consecutively performed HALDN donors were compared to 56 preceding ODN patients. Patients with multiple arteries, right-sided nephrectomies and obesity were included. Data on recovery and complications were collected prospectively and consecutively.

Results. There were two (1.4%) major complications in the HALDN group and one in the ODN group (1.8%, P = 0.629). Additionally, there were 24 minor complications in 23 HADLN patients (16.7%), compared with 21 in 21 ODN patients (37.5%, P = 0.003). Time taken to return to normal activity and mean post-operative stay was significantly shorter for the HALDN group. There was no mortality in either group.

Conclusions. Contrary to concerns, we report a safe experience with HALDN with a low rate of major complications. Furthermore, our patients spend less time in hospital with an earlier return to normal activity compared with open donation.

Keywords: donor; hand-assisted; laparoscopic; living; nephrectomy



   Introduction
Top
 Abstract
 Introduction
Patients and methods
 Results
 Discussion
 References
 
Living donation transplantation has become the treatment of choice for end-stage renal failure with better graft and patient survival when compared with deceased donor transplantation [1]. The major disadvantage of living donation is the risk of morbidity and mortality for the donor. Before the first description of laparoscopic living donation in 1995 [2], donor nephrectomy was performed via the open surgical approach producing significant donor morbidity. Since then, laparoscopic donor nephrectomy has been reported by various studies [3,4] including four randomized-controlled trials [5–8]. Despite the relatively small number of patients, these trials have confirmed the relative advantages of laparoscopic donor nephrectomy compared with the open approach, with less postoperative pain, decreased hospital stay and earlier return to normal activity for donors. This has made laparoscopic surgery an attractive option for potential living donors, and in 2006 the majority of donor nephrectomies were laparoscopic in the United Kingdom [9]. However, concerns have been raised about the safety of laparoscopic living donation including donor deaths following haemorrhage [10] and a high rate of re-operation [5]. The main concerns revolve around haemorrhage necessitating conversion to open surgery and gastrointestinal injury including bowel perforation.

Hand-assisted laparoscopic donor nephrectomy (HALDN) may be the safest option as the surgeon may palpate vital structures and organs minimizing intra-operative injury as well as retracting tissues and securing haemostasis. The technique also minimizes warm ischaemic time (WIT) compared with pure laparoscopic donor nephrectomy [11]. We currently have no absolute contraindications to the HALDN technique for living donors. Obese patients and patients with multiple vessels or right-sided donor nephrectomies are all offered HALDN. The aim of this study is to assess the safety of all HALDN performed in our centre compared with a cohort of historical open donors in order to determine whether concerns over the risks of laparoscopic donor nephrectomy are justified.



   Patients and methods
Top
 Abstract
 Introduction
 Patients and methods
Results
 Discussion
 References
 
This study includes 200 patients, of whom 144 donors underwent HALDN consecutively over a total period of 40 months. These cases were compared with the preceding 56 consecutive open donor nephrectomy patients (ODN) as a historical control. The open cases were performed over a total period of 12 months. This represents our total experience of HALDN where initially procedures were supervised, then telementored [12] and subsequently performed independently. For the last year, all our living donors underwent pure HALDN. The technical aspects of HALDN and ODN have been described elsewhere [13]. Ten cases were either robot-assisted or retroperitoneal in approach. Our HALDN patient group included patients with multiple arteries and patients with body mass indexes (BMIs) up to and including 35. The cases were performed by two surgeons in our unit adopting the same techniques in their approach.

For HALDN donors, a midline or pfannenstiel incision of 7–8 cm was used for the hand assist GelportTM (Applied Medical, CA, USA) with two 12 mm ports. For ODN cases, a standard subcostal flank approach with varying incision lengths was adopted without rib resection. Data including minor and major complications, time taken to return to normal activity and hospital stay for the HALDN group were recorded prospectively and compared to historical retrospective data from the ODN cases. We defined our major and minor complications based on a modification of the Clavien classification system [14] of procedure-related negative outcomes in surgery. This system has been used by others to report complications after live donor nephrectomy [15]. Essentially, a major complication refers to a potentially life-threatening incident usually requiring some form of intervention in order to prevent death such as conversion to open surgery for severe intraoperative haemorrhage. In addition, we have further modified this definition to include damage incurred to the donor organ at the time of the retrieval procedure as, although this is not life threatening, it presents a risk of non-function. Minor complications include events within the perioperative period that can alter patient recovery and prolong hospital stay. Follow-up included a review at 2 months and 1 year.

We defined the time taken to return to normal activity as a return to the same level of activity status as preoperatively. This was assessed during the post-operative follow-up consultation. In addition, we defined chronic wound pain as the need for analgesia and/or a failure to return to normal activity levels at 6 months post-operatively.

Statistical analysis
The {chi}2 test or Fisher's exact test was used to analyse categorical data according to the sample size. Numerical data were analysed using the unpaired t-test for parametric data and the Mann–Whitney U-test for non-parametric data.



   Results
Top
 Abstract
 Introduction
 Patients and methods
 Results
Discussion
 References
 
Comparative demographic data between the two patient groups are shown in Table 1. There were 144 HALDN cases, compared with 56 ODN cases with no significant difference in mean age or pre- and post (day 1) operative creatinine, between the two groups. As expected, there was a statistically significant longer operating time associated with the HALDN procedure. The mean estimated blood loss (EBL) for the HALDN group was 160 ml and the WIT 172 s. Data relating to WIT and EBL for the open group were not available.


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  		Table 1 Comparative demographic data of HALDN and ODN donor groups

 
Twenty-three patients in the HALDN group and 21 patients in the ODN group had complications which represent a rate of 16% and 37.5% respectively (Table 2). There were no mortalities in either group. There were two major complications in the HALDN group and one in the ODN group. The first major complication in the HALDN group was conversion to open surgery for intraoperative haemorrhage (conversion rate of 0.7%). The patient had a satisfactory operative outcome and did not require blood transfusion. The second complication was diathermy damage to a branch of the donor renal artery requiring surgical reconstruction using an end-to-end anastomotic technique prior to transplantation. After an initial period of delayed graft function, the recipient had a satisfactory outcome. The major complication in the ODN group was emergency surgical re-exploration of a patient for haemorrhage from the main renal artery stump, requiring transfusion of four units. This patient also had a satisfactory outcome. The ODN major complication rate of 1.8% was not significantly different to the HALDN major complication rate (P = 0.629).


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  		Table 2 Outcome data of HALDN compared to ODN donor groups

 
Minor donor complications (Table 3) were different in rate and spectrum between the HALDN and ODN groups (24 versus 21 respectively). Three individual donors in the HALDN group and one in the open group experienced more than one minor complication. Postoperative chronic wound pain was significantly more prevalent in the ODN group (P < 0.001). Testicular pain was more prevalent in the HALDN group but this did not reach statistical difference. Postoperative stay was different in the two groups reaching statistical significance (P < 0.001) as was the time taken to return to normal activity (P < 0.001), both being shorter for the HALDN cases. There were no mortalities in either recipient group. However, one transplant recipient developed ureteric necrosis in the HALDN group. The ureter was successfully re-implanted into the bladder with a satisfactory graft outcome. Two patients developed delayed graft function in the HALDN group. In addition, there was one re-admission for abdominal pain in the HALDN group, requiring re-laparoscopy, and a further re-laparoscopy for pain in a patient before discharge. Re-laparoscopy proved unremarkable in these two recipients. The pain may have been due to peritoneal irritation by residual urine (the CRP was raised in both patients). After a period of conservative management both were discharged uneventfully.


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  		Table 3 Comparative distribution of minor complications between HALDN and ODN donor groups

 


   Discussion
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Discussion
References
 
We have had a safe experience with HALDN and our series has shown HALDN to be an acceptable approach to living donation. We have shown that major complications are rare, and there was no significant difference in major complication rates between the two groups (1.4% versus 1.8% in the HALDN and ODN groups, respectively, P = 0.629).

However, the minor complications were significantly higher in the ODN group (38%) compared to the HALDN group (16.7%, P = 0.003). Wound pain was significantly higher in the ODN group, probably due to muscle cutting procedure or subcostal nerve injury, and this may have a detrimental effect upon time taken to return to normal activity. This may have implications for donors returning to work as most are in full-time employment.

The relative advantages of HALDN make it a better option for patients offering kidneys for living donation in the presence of an increasing demand for renal transplantation in an ageing population. It is now the method of choice for living donation in our unit, and there are no circumstances in which we prefer open donation apart from patient preference. We realize the importance of a large randomized control trial of HALDN compared to ODN, but in the light of increasing awareness of the advantages of HALDN compared to ODN amongst patients, conducting such trials may be difficult in the future [16]. Trials have been small in patient numbers and few studies have been able to address specific donor complications. The Norwegian trial reported five major complications requiring re-operation including two intestinal perforations in a total of 63 laparoscopic donors. They reported no major complications in their ODN group of 59 patients thereby claiming that ODN was more superior in terms of safety compared to laparoscopic donor nephrectomy [5]. Our series does not suggest this. However, with the increasing number of centres adopting and learning such techniques, coupled with the availability of UK Registry data, comparison of donor outcomes in large numbers may be possible.

A challenging area in renal transplantation revolves around insufficient numbers of suitable cadaveric donors for the increasing population of people with end-stage renal disease. This culminates in prolonged waiting times on the transplant list. Living donation of kidneys has therefore increased, providing a vital source of organs for these patients. It is associated with improved patient and graft survival compared to cadaveric transplantation [17]. Indeed, since 2001, the number of live kidney donors in the USA has surpassed the number of cadaveric donors, the trend being attributed to improved surgical techniques such as laparoscopy but also to increased public awareness [18,19]. It is therefore currently the treatment of choice for end-stage renal failure. Prior to 1995, open surgery was the conventional method for living donation but was associated with much morbidity including formation of a hernia, postoperative pain and increased length of hospital stay. Minimally invasive, laparoscopic nephrectomy has become increasingly accepted as a procedure for living donation with a complication rate comparable with OPN [20,21].

Several studies and reviews have established that laparoscopic minimally invasive donor nephrectomy, hand assisted or otherwise, has the advantages of shorter hospital stay and recovery time, earlier return to normal activity and less scarring [4,13,22,23]. Concerns about these minimally invasive techniques still persist however and revolve around two major life-threatening complications: sudden severe bleeding [10] or gastrointestinal injury [5,24,25].

Our conversion rate for haemorrhage of 0.7% compares favourably to other reports in the literature [26,27]. In addition, we report no major gastrointestinal injury in this patient group. Our ODN donor haemorrhage rate was 1.8%, which was not significantly different from the HALDN major complication rate. We report no major gastrointestinal injury in this patient group. Therefore, we have demonstrated the relative safety associated with HALDN as an alternative to open nephrectomy for living donation. It is a difficult procedure associated with a learning curve that has been further aided by the use of telementoring in our early cases [12]. However, there are few prospective studies on HADLN and fewer randomized-controlled trials. Our series of 144 HALDN nephrectomies represents a non-randomized prospective sequential comparative study of specific donor complications, length of stay and recovery compared with 56 historical open donor retrospective nephrectomy controls. Our results show that in terms of post-operative inpatient stay and return to normal activity levels, HALDN is more favourable compared to ODN with a fewer number of complications. Our results for hospitalization for the HALDN group (median 3 days) compare favourably to previous reports in the literature [13,22].

The limitations of this study are that it is non-randomized with a small group of historical controls and that we have not reported on our graft survival rates. It is possible that significant differences between the two groups have not become apparent; however, the essential aim of our study in demonstrating the overall safety of HALDN should not be affected.

The main advantage of HALDN over pure laparoscopic surgery is the tactile sensory feedback afforded by having a hand within the intraoperative field enabling palpation and blunt dissection of structures. More critically, control of brisk intraoperative haemorrhage is possible with HALDN, as illustrated by our patient who needed to be converted to open surgery but without the need for blood transfusion. Control of haemorrhage remains one of the main concerns associated with pure laparoscopic live donor nephrectomy. Totally laparoscopic donor nephrectomy has been reported to have a significantly higher complication rate than HALDN, 21% and 3.3% respectively [28], and results in a longer warm ischaemic time as well as total operating time [22]. However, a recent randomized control trial between HALDN and standard laparoscopic donor surgery reported similar outcomes and postoperative pain [29]. Both HALDN and laparoscopic donor nephrectomy enable earlier return to normal physical activity compared to open donation [30].

In conclusion, our series has shown HALDN to be a safe procedure compared with open donation and is now standard policy in our unit.

Conflict of interest statement. None declared.



   References
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Discussion
 References
 

  1. US Renal Data System, USRDS. Annual Data Report (1994) Bethesda: The National Institutes of Diabetes and Digestive and Kidney Diseases.
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Received for publication: 2.12.07
Accepted in revised form: 22. 7.08


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