Comparison of laparoscopic and open donor nephrectomy: a randomized controlled trial

Authors

  • Nasser Simforoosh,

    1. Department of Urology and Renal Transplantation, Urology and Nephrology Research Center, Shahid Labbafi Nejad Hospital, Shahid Beheshti University of Medical Science, Tehran, Iran
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  • Abbas Basiri,

    1. Department of Urology and Renal Transplantation, Urology and Nephrology Research Center, Shahid Labbafi Nejad Hospital, Shahid Beheshti University of Medical Science, Tehran, Iran
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  • Ali Tabibi,

    1. Department of Urology and Renal Transplantation, Urology and Nephrology Research Center, Shahid Labbafi Nejad Hospital, Shahid Beheshti University of Medical Science, Tehran, Iran
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  • Nasser Shakhssalim,

    1. Department of Urology and Renal Transplantation, Urology and Nephrology Research Center, Shahid Labbafi Nejad Hospital, Shahid Beheshti University of Medical Science, Tehran, Iran
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  • Seyed M.M. Hosseini Moghaddam

    1. Department of Urology and Renal Transplantation, Urology and Nephrology Research Center, Shahid Labbafi Nejad Hospital, Shahid Beheshti University of Medical Science, Tehran, Iran
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Nasser Simforoosh, Urology Nephrology Research Centre, Shahid Labbafinejad Hospital, Boostan 9th St., Pasdaran Ave, PO Box 1666679951, Tehran, Iran.
e-mail: simforoosh@iurtc.org.ir

Abstract

Authors from Iran compare various outcomes between laparoscopic and open donor nephrectomy in kidney transplantation; they carried out a large comparative trial, and found that laparoscopic donor nephrectomy gave better donor satisfaction and morbidity, with equivalent graft outcome.

OBJECTIVE

To compare the graft survival, donor and recipient outcome, donor satisfaction, and complications of laparoscopic (LDN) and open donor nephrectomy (ODN) in kidney transplantation.

PATIENTS AND METHODS

In a randomized controlled trial, 100 cases each of LDN and ODN were compared. We modified the standard LDN procedure to make it less expensive.

RESULTS

The mean (sd) operative duration was 152.2 (33.9) min for ODN and 270.8 (58.5) min for LDN, and the mean duration of kidney warm ischaemia was 1.87 min for ODN and 8.7 min for LDN. Only one LDN required conversion to ODN because of bleeding. The mean follow-up in the LDN and ODN groups was not significantly different (406.1 vs 403.8 days). The mean (sd) score for donor satisfaction was 17.3 (3.5) for ODN and 19.6 (1.0) for LDN. The rate of ureteric complications was 2% for ODN and none for LDN. As determined by serum creatinine levels at 3, 21–30, 90, 180 and 365 days after surgery, graft function was not significantly different between ODN and LDN. Long-term graft survival was 93.8% for LDN and 92.7% for ODN.

CONCLUSIONS

Compared to ODN, LDN was associated with greater donor satisfaction, less morbidity and equivalent graft outcome.

Abbreviations
L(O)DN

laparoscopic (open) donor nephrectomy

BMI

body mass index

INTRODUCTION

Laparoscopic donor nephrectomy (LDN) was developed in an attempt to increase the frequency of kidney donation by reducing the disincentives to donation, capitalising on the associated reduced morbidity [1]. Ratner et al[2] reported the first successful human LDN in 1995. Later descriptive studies reported that the morbidity of LDN was less than with open DN (ODN) and that the long-term renal graft function of LDN was equivalent to that of ODN [2–4]. To our knowledge, the present study is the first randomized clinical trial comparing LDN and ODN. Preliminary results were reported previously [5].

PATIENTS AND METHODS

The present prospective study began after gaining experience from 90 cases of LDN, and includes 100 cases of LDN and 100 of ODN performed between July 2001 and September 2003. Eligibility criteria were as follows: donor body mass index (BMI) <28 kg/m2; no complexity in the donor kidney vessels; recipient aged 18–65 years; and no haemolytic uraemic syndrome or focal segmental glomerulosclerosis and oxalosis in the recipient. All donors were evaluated at an outpatient visit 7–10 days after surgery. A telephone interview was conducted for donors at the closing date of study. The LDN or ODN was performed by two co-surgeons (68 ODN and 69 LDN by N.S. and 32 ODN and 31 LDN by A.B.) on the left kidney in all patients. The kidney was transplanted by the same urologist who did the nephrectomy.

The authors’ institution has adopted codes of ethics to guide human experimentation. After patients had been recruited and signed an informed consent form, they were assigned randomly to ODN and LDN groups, using a balanced randomization method [6].

The BMI was calculated; the warm ischaemia time was defined as the time from renal artery occlusion to kidney immersion in ice-slush, and operating time as the time from the initial skin incision to the final skin suture. Cold ischaemia time was defined as the time between kidney immersion in ice-slush and graft revascularization. Serial creatinine levels were measured in the recipient and recorded at 3 and 21–30 days, and 3, 6 and 12 months after transplantation. The definition of delayed graft function varies in different studies [7]; we defined delayed graft function as serum creatinine levels of >35 mg/L on the third day after transplantation. Using a 20-point visual analogue scale (0 = no satisfaction to 20 = full satisfaction), we assessed donor satisfaction for discomfort and cosmetic result; the validity of this scaling method has not been assessed in previous studies.

All potential donors had an extensive medical and psychological evaluation, and received a light mechanical bowel preparation 12 h before surgery. Donors underwent conventional angiography or digital subtraction angiography to evaluate the anatomy of the kidney vasculature, and all donors with multiple renal arteries were excluded.

The surgical technique used for ODN was the standard retroperitoneal flank approach. For LDN, under general anaesthesia and using a transperitoneal approach in the modified flank position, a video laparoscope was introduced through a 12-mm umbilical port; 12-mm pararectal and 5-mm epigastric ports were used for the dissecting instruments. We used the following modifications to the conventional LDN: (i) the first trocar was introduced in an open technique using an ordinary non-disposable trocar (no Hasson's trocar was used); (ii) we used three medium-large metal clips instead of an Endo-GIA stapler for ligating the renal veins and arteries; (iii) no organ-extracting device (e.g. Endo-catch bag) was used; the kidney was extracted manually via an 8–10 cm suprapubic incision.

The results were assessed statistically using Student's t-test, nonparametric Mann–Whitney, Kaplan–Meier and chi-square tests as appropriate, with significance considered to be indicated at P < 0.05.

RESULTS

The patient demographics and surgical outcomes in the ODN and LDN groups are shown in Table 1. All nephrectomies were completed as scheduled, except for one LDN that required conversion to ODN because of bleeding. The mean (range) kidney warm ischaemia time was 1.87 (1–5) min for ODN and 8.7 (4–17) min for LDN (P < 0.001). The mean interval between the beginning of surgery and cold washing of the kidney was 205 (123–320) min in the LDN and 89.13 (40–209) min in the ODN group (P < 0.001), and the mean cold ischaemia time 48 (20–106) min and 49.4 (15–118) min, respectively.

Table 1.  Patient characteristics and complications during and after ODN and LDN (both 100 patients)
Characteristics/complicationsODNLDNP
Mean (sd):
age, years 29.2 (5.2) 27.8 (3.9)0.06
weight, kg 67.3 (9.7) 64.4 (9)0.03
height, cm172.2 (8.5)170.5 (7.4)0.15
BMI, kg/m2 22.67 (2.7) 22.2 (2.9)0.19
Donor sex (M/F) 92/8 86/140.17
Mean (range):
follow up, days403.8 (18–787)406.1 (11–791)0.9
operating time, min152.2 (80–260)270.8 (165–490)<0.001
hospital stay, days  2.2 (2–8)  2.26 (2–5)0.5
haematocrit difference, % before and day  after surgery  3.7 (−2.3–12.4) 4.1 (−3.7–11.4)0.21
[median] inpatient parenteral analgesic, mg 10.8 (11–80) [5]  11.5 (0–85) [5]0.7
Intraoperative donor complications, n
None 82 96 
Pneumothorax 18  0 
Splenic laceration  0  2 
Cardiac arrhythmia  0  1 
Bowel serosal injury  0  1 
Postoperative donor complications, n
None 91 83 
Bleeding  1  4 
Retention  0  1 
Ileus  4  7 
Thigh numbness  1  1 
UTI  2  1 
Scrotal swelling  0  3 
Subcutaneous collection  1  2 

No patients in the ODN group and only one in the LDN group required a blood transfusion during surgery. Two patients who had an ODN and one who had a LDN required re-operation. The reasons for re-operation were surgical site bleeding (one patient in each group) and pleural haemorrhage (one patient in the ODN group). There were no cases of malfunction of vascular clips on major vessels in the LDN group. Minor intraoperative complications are also shown in Table 1. A chest tube was inserted for all cases with intraoperative pneumothorax. The rate of postoperative donor complications was 17% in the LDN group and 9% in the ODN group (Table 1). There were no major complications in either group.

The mean (sd) score for donor satisfaction was 17.3 (3.5) for ODN and 19.6 (1.0) for LDN (P < 0.001). Eighty-five patients in the ODN group and 83 in the LDN group were discharged within 48 h of surgery. Table 2 shows the delay to resumption of ‘normal’ activities after LDN or ODN.

Table 2.  Delay (in days) to resumption of ‘normal’ activities in donors
ActivitiesMean (median, range)P
ODNLDN
Light activities 7.9 (5.5, 2–40) 5.9 (4, 2–30)0.05
Heavy activities56.6 (60, 5–210)34 (30, 7–90)0.002
Driving a vehicle20.8 (15, 2–150) 11.6 (7, 2–60)0.004
Receiving analgesia, after discharge 7.8 (5, 0–40) 3.3 (3, 0–20)<0.001

Three kidney recipients in the ODN group but none in the LDN group were donors’ first relatives. Two recipients in the LDN group and three recipients in the ODN group died, the reasons for death being given in Table 3. Long-term recipient survival was 96.9% in the ODN group and 97.9% in the LDN group (no significant difference; Wilcoxon statistic).

Table 3.  Recipient deaths in each group
Cause of deathGroupMonths after transplantation
CardiovascularLDN 0 (day of transplantation)
Pulmonary emboliLDN 3
Uraemia and pneumoniaODN 11
CardiovascularODN 6
Uraemia and infectionODN12

Ten recipients in the ODN and five in the LDN group had a history of previous kidney transplantation. The rate of recipient urological complications in the LDN and ODN groups was none and 6%, respectively. In the ODN group they included vein thrombosis in one patient (1%), stricture of the ureteric anastomosis in one (1%), lymphocele in two (2%), and both ureteric anastomosis leakage and lymphocele in one (1%). The rate of ureteric complications was none in the LDN group and 2% in the ODN group.

Delayed graft function was diagnosed in eight patients in the ODN and 11 in the LDN group. Within 3 months after transplantation, acute tubular necrosis was diagnosed in seven patients in the ODN and in 11 in the LDN group; and acute rejection in 11 in the ODN and in two in the LDN group. Graft function was not significantly different between the LDN and ODN groups, as determined by serum creatinine levels after surgery (Table 4). Long-term graft survival was 93.8% in the LDN and 92.7% in the ODN group. Three recipients in the ODN and two in the LDN group were lost to long-term follow-up.

Table 4.  Demographic characteristics and serum creatinine levels of recipients
Recipient variableNMean (range)P
Age, years
ODN10038.6 (18–61)  0.07
LDN10035.6 (18–61) 
Weight, kg
ODN10063.5 (32–102)  0.9
LDN10063.45 (34–106) 
Male to female ratio
ODN 61/39   0.6
LDN 65/35  
Serum creatinine, mg/L, days after surgery
3
ODN10018.5 (5–136)  0.23
LDN10020.1 (7–125) 
21–30
ODN10014 (5–30)  0.35
LDN10016 (7–123) 
90
ODN 7714.1 (6–47)  0.46
LDN 7814.7 (7–40) 
180
ODN 6914.5 (7–43)  0.11
LDN 6414.1 (5–91) 
365
ODN 4813.0 (7–24)  0.94
LDN 5313.2 (8–28) 

DISCUSSION

Kuo et al.[8] reported that obese donors (BMI > 31 kg/m2) have similar outcomes with LDN as non-obese donors, but other studies have found that increasing patient weight correlates with longer operative duration [9]. To minimize the impact of obesity as an effect modifier, we narrowed the inclusion criteria of the present study to only include donors with a BMI of <28 kg/m2.

Some researchers showed a halving in hospital stay for LDN and a more rapid return to work [1,10–12]. Lind et al.[3] stressed that LDN is associated with a shorter hospital stay than is ODN (2.2–2.7 vs 3.8–5.7 days). In our transplantation centre, the policy is to favour reducing the hospital stay, regardless of surgical technique. In the present study, the mean hospital stay in the LDN group was similar to that in other studies, but the mean hospital stay in the ODN group was shorter than in other reports.

Compared with ODN, LDN results in a shorter time until patients are able to drive, take care of the home, and return to full activity, work and regular exercise [11]. We divided the ordinary activities into ‘light activities’, ‘heavy activities’ and ‘ability for driving’. Donors in the LDN group had a significantly shorter delay to resuming each type of activity. Advantages of LDN thus include less loss of income and thus a lower financial burden for donors [13]. The cosmetic result of LDN is also better than that of ODN [14–16] and this seems to be important for the present patients’ reported satisfaction.

Using a 20-point visual analogue scale, there was significantly less reported pain in the LDN group, although the mean dose of parenteral analgesic delivered in hospital was not significantly different between the groups. The mean number of days receiving analgesia after discharge was lower in the LDN group. In the study of Waller et al.[17], donors were managed after surgery with a patient-controlled analgesia system and LDN was associated with less postoperative pain and a lower analgesic requirement.

The present study showed that warm ischaemia time (within the range of our data) did not significantly affect graft function. Buzdon et al.[18] reported on 640 LDNs and found no effect of warm ischaemia time on recipient graft function within the range of 35–720 s. In the present study the longest time of warm ischaemia was 1020 s, longer than that recommended as a safe limit by Buzdon et al.[18]. Warm ischaemia time (within the present range) had no correlation with recipient serum creatinine levels at the measured intervals, suggesting that any damage from warm ischaemia might be reversible.

In the present study, there was no significant difference in postoperative complications between the groups. Donor complications in the LDN group seem to be declining, and with increasing experience should be less common. In previous studies, the conversion rate from LDN to ODN was 1.6–13%[11,19], but such conversion was required in only one patient in the present study.

There is a different pattern of complications and morbidity in ODN. Although one report [10] showed that ODN has a higher incidence of pneumothorax, flank nerve entrapment and flank hernia, in the present study one patient in each of the groups had thigh numbness which might be a result of nerve entrapment in the flank. Patients in both the present groups had no major intraoperative complications. In a recent series from the University of Maryland [19] among 738 LDNs 15 major complications, including 13 vascular injuries and two bowel injuries, were reported. In the present study, two patients who had an ODN and one who had LDN required reoperation.

In the present study, recipients after LDN had no ureteric complications. We performed a wide dissection around the ureter, maintaining adequate peri-ureteric fat; this wide dissection might explain the relatively low incidence of recipient ureteric complications. We also had no complications from trocar entry; this success probably reflects the policy of simple open access, whereby we introduced a regular reusable trocar from a 1.5-cm incision above the umbilicus (a modification of Hasson's technique). The success of this LDN modification lowers the financial burden upon donors, which might be particularly important for donors in developing countries. Further efforts should be made to simplify laparoscopic instrumentation and lower the cost of surgical instruments used for LDN.

LDN seems to be an attractive alternative to ODN. Our modification to LDN is technically feasible and, compared to ODN, gives greater donor satisfaction, a faster return to work and ordinary activities, and less pain after surgery. Kidneys harvested by LDN have equivalent function to those harvested by ODN, graft survival is similar with the two approaches, and the warm ischaemia time (within the range of our data) appears to be safe.

CONFLICT OF INTEREST

None declared. Source of funding: Urology Nephrology Research Center (UNRC).

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