Hand Assisted Laparoscopic Radical Nephrectomy: Comparison With Open Radical Nephrectomy

0022-5347/03/1703-0756/0 THE JOURNAL OF UROLOGY® Copyright © 2003 by AMERICAN UROLOGICAL ASSOCIATION

Vol. 170, 756 –759, September 2003 Printed in U.S.A.

DOI: 10.1097/01.ju.0000080537.28752.aa

HAND ASSISTED LAPAROSCOPIC RADICAL NEPHRECTOMY: COMPARISON WITH OPEN RADICAL NEPHRECTOMY SANG EUN LEE,* JA HYEON KU, CHEOL KWAK, HYEON HOE KIM

AND

SUNG HYUN PAICK

From the Departments of Urology, Seoul National University College of Medicine (SEL, JHK, CK, HHK), Seoul National University Hospital (SHP), Seoul, Korea

ABSTRACT

Purpose: We compared the results of hand assisted laparoscopic and conventional open radical nephrectomy. Materials and Methods: Clinical data on 54 hand assisted and 50 open radical nephrectomies performed at our hospital from September 1999 to October 2002 were reviewed. Results: Mean operative time in the laparoscopic and open groups was similar (194.9 and 180.7 minutes, respectively, p ⫽ 0.087). However, estimated mean blood loss (182.8 vs 262.8 ml, p ⬍0.001), mean days to oral intake (2.6 vs 3.7 days, p ⬍0.001) mean duration of an indwelling drain (2.6 vs 3.2 days, p ⬍0.001) and mean hospital stay (6.8 vs 8.9 days, p ⬍0.001) were significantly less in the laparoscopic group. In the laparoscopic group no conversions or reexplorations were required and no major complications occurred. Conclusions: Our findings suggest that hand assisted laparoscopic radical nephrectomy represents an effective, minimally invasive treatment option in patients with suspected renal cell carcinoma. KEY WORDS: kidney; carcinoma, renal cell; laparoscopy; nephrectomy

Laparoscopic nephrectomy was introduced in 1991 by Clayman et al1 and laparoscopic radical nephrectomy for renal cell carcinoma is routinely performed at several institutions.2– 4 The laparoscopic approach offers significant advantages, including less postoperative pain, decreased hospital stay, improved convalescence and a more favorable cosmetic result, than that obtained with open surgery.5–7 Despite these advantages the 2 major drawbacks of the laparoscopic approach are the lengthy operative time required and the need for a surgeon with experience to perform this type of operation. In addition, laparoscopic radical nephrectomy for renal malignant diseases differs from surgery for benign renal diseases because it includes en bloc removal of the kidney, adrenal gland, perinephric fatty tissue, Gerota’s fascia, proximal half of the ureter and renal hilar lymph nodes. Furthermore, surgeons must ligate the renal artery and subsequently the renal vein without manipulating the kidney.8 The introduction of hand assistance for transperitoneal laparoscopy provides a more rapid and safer technique for difficult laparoscopic procedures without sacrificing improvement in patient convalescence, which is the benefit of minimally invasive procedures.9 Hand assisted laparoscopy allows surgeons to use the nondominant hand with a standard laparoscopic instrument, provides the tactile sensation missing from standard laparoscopy and allows them to use 1 hand to dissect tissue, retract structures, tie sutures and help secure hemostasis. It also decreases operative time and may allow experienced laparoscopic surgeons to expand the scope of cases performed laparoscopically. Hand assisted laparoscopic radical nephrectomy has gained popularity with the advent of commercial devices that reliably maintain pneumoperitoneum.10 Given the advantages conferred by the hand assisted technique when applied to radical nephrectomy, there must be a strong likelihood that hand assisted laparoscopic nephrectomy has some advantages over

open nephrectomy in terms of decreased morbidity and shortened convalescence, while maintaining comparable outcomes. In addition, the hand assisted transperitoneal laparoscopic technique must be evaluated for this procedure in comparative fashion. However, previous studies included a relatively small number of cases8, 11, 12 and additional studies with larger sample sizes are needed. In the current study we summarized the results of our 54 consecutive hand assisted laparoscopic radical nephrectomies and compared these results with those of 50 consecutive open radical nephrectomies. MATERIALS AND METHODS

Patients. Between September 1999 and October 2002 hand assisted radical nephrectomy was performed in 42 men and 12 women 27 to 80 years old (mean age 50.7). We compared the results in these patients with those in 34 men and 16 women 24 to 77 years old (mean age 53.8) treated with conventional open radical nephrectomy between January 1998 and September 1999. Laparoscopic cases satisfied specific study inclusion criteria, including lesion size 10 cm or less, stages T1 to T3a disease and no renal vein or inferior vena caval involvement. Before surgery no patient showed evidence of metastatic disease on abdominal computerized tomography and chest x-ray. Of the patients who underwent open radical nephrectomy all who met a set of identical selection criteria were selected for open surgical comparison. Patients underwent hand assisted laparoscopic and open radical nephrectomy for renal tumors 1.2 to 9 (mean 4.4) and 1.0 to 9.5 cm (mean 4.7), respectively. Clinical stage of the renal tumors was cT1–2N0M0. Demographics of the 2 groups were similar in terms of age, body mass index, gender, tumor side and tumor diameter. Table 1 lists patient characteristics. Operative technique. Hand assisted laparoscopic radical nephrectomy was performed via a transperitoneal approach in all cases, as described previously9 but with some slight modifications. Briefly, the patient was placed in a modified lateral decubitus position. For left radical nephrectomy laparoscopic access to the peritoneum was obtained with a Veress

Accepted for publication April 17, 2003. * Corresponding author: Department of Urology, Seoul National University Hospital, 28, Yongon-Dong, Jongno-Ku, Seoul, Korea 110744 (telephone: 82-2-760-2408; FAX: 82-2-742-4665; e-mail: urology@ snu.ac.kr). 756

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HAND ASSISTED LAPAROSCOPIC NEPHRECTOMY TABLE 1. Clinical characteristics of hand assisted laparoscopic and open nephrectomy No. pts Mean age (range) Mean body mass index (range) No. sex (%): Male Female No. side (%): Rt Lt Mean tumor diameter (cm): Mean (range) No. less than 4 (%) No. 4–7 (%) No. greater than 7 (%) Mean ASA score (range)

Laparoscopy

Open Surgery

54 50.7 (27–80) 24.0 (17.8–29.8)

50 53.8 (22–77) 24.4 (16.0–30.6)

42 12

(77.8) (22.2)

34 16

(68.0) (32.0)

23 31

(42.6) (57.4)

27 23

(54.0) (46.0)

p Value 0.196 (Student t test) 0.453 (Student t test) 0.261 (chi-square test) 0.245 (chi-square test)

4.4 21 29 4 1.5

(1.2–9.0) (38.9) (53.7) (7.4) (1–3)

needle. Two 12 mm ports, including 1 for a video laparoscope and 1 used as a working port, were placed in the midclavicular line at the umbilical level and in the anterior axillary line at the subcostal level, respectively. Manual access to the abdomen was achieved through a vertical 7 cm supraumbilical incision using a hand assisted device, that is a PneumoSleeve (Dexterity, Blue Bell, Pennsylvania) or Intromit (Applied Medical, Rancho Santa Margarita, California). The hand assisted device was placed in the infraumbilical position for right nephrectomy. The surgeon left hand was inserted into the peritoneal cavity for right and left nephrectomy and used for manual retraction, dissection and hemostasis. Laparoscopic nephrectomy was then performed using the left intra-abdominal hand to facilitate maneuvers such as retraction of the spleen, liver and colon. After control and division of the ureter and gonadal vein the renal artery was circumferentially mobilized, clipped and divided. The renal vein was then secured and simultaneously transected with a vascular endoscopic gastrointestinal anastomosis device (United States Surgical Corp., Norwalk, Connecticut). The kidney, adrenal gland and Gerota’s fascia were freed en bloc and the specimen was removed intact through the hand assisted device without using an entrapment sac. A transabdominal approach was used in all 50 patients who underwent conventional open radical nephrectomy. Statistical analysis. The parameters evaluated in each group were overall operative time, estimated blood loss, transfusion rate, number of days to first postoperative oral intake, duration of an indwelling drain, postoperative hospital stay, and intraoperative and postoperative complications. Postoperatively analgesics were prescribed as needed but use was not standardized. Patients were encouraged to begin oral intake as soon as they sensed hunger or thirst and after the return of bowel function was confirmed. Ambulation was also encouraged. The drain was removed at less than 20 ml/24 hours. Statistical comparisons of continuous data on hand assisted laparoscopic and open radical nephrectomy data were performed using the Student t or the Mann-Whitney U test. Categorical variables were compared using the chisquare or Fisher’s exact test.

4.7 19 24 7 1.8

(1.0–9.5) (38.0) (48.0) (14.0) (1–3)

0.327 (Student t test)

0.012 (Student t test)

To evaluate factors influencing operation time ORs for increased operative time, that is greater than 180 minutes (chosen as the cutoff based on series mean operative time) with respect to operation type, sex, age, tumor side and diameter, body mass index, American Society of Anesthesiologists (ASA) score, estimated blood loss, specimen weight and p values for trend were estimated by multivariate logistic regression analysis in 104 patients. For the laparoscopic group only surgeon experience was included in place of operation type in the multivariate model. Patients were stratified by age into 2 groups, including 60 years or younger and older than 60 years. Tumor diameter was assessed in 2 categories, that is 7 cm or less and greater than 7 cm. Body mass index was classified as less or greater than 25.0 kg/m2. ASA score was defined as 1 or less, or greater than 1. Estimated blood loss was categorized as 200 cc or less, or greater than 200 cc. Specimen weight was categorized as 200 gm or less, or greater than 200 gm. Associations among these parameters and increased operative time were described using maximum likelihood estimates of relative risk and the 95% CI based on the multiple logistic regression model. A 5% level of significance was used for all statistical testing and all statistical tests were 2-sided. Commercially available software (SPSS, Inc., Chicago, Illinois) was used for all statistical analyses. RESULTS

Of the 104 patients who underwent radical nephrectomy all except 5 who underwent hand assisted laparoscopic radical nephrectomy had renal cell carcinoma. The 5 exceptions consisted of 1 oncocytoma, 1 multilocular cyst, 1 cystic adenoma and 2 leiomyomas. Pathological stage of all renal cell carcinomas was pT1 or pT2. Tumor margin was negative in all patients with renal cell carcinoma. Demographic characteristics, operative parameters and convalescence parameters were compared according to pathological stage. There were no significant differences in any parameters except specimen weight between patients with stages 1 and 2 renal cell carcinomas (data not shown). Table 2 compares the 2 surgical procedures with respect to operative and convalescence parameters. Mean operative

TABLE 2. Operative and convalescence parameters for hand assisted laparoscopic and open nephrectomy Mean mins operative time (range) Mean ml estimated blood loss (range) % Transfusion (No. pts) Mean gm specimen wt (range) Mean days to oral intake (range) Mean days indwelling drain (range) Mean days hospitalization (range) % Complications (No. pts): Major Minor

Laparoscopy

Open Surgery

p Value

194.9 (105–310) 182.8 (50–600) 7.4 (4) 235.5 (117–826) 2.6 (1–8) 2.6 (1–5) 6.8 (3–15) 5.6 (3) 0.0 5.6 (3)

180.7 (95–270) 262.8 (100–500) 6.0 (3) 227.2 (124–465) 3.2 (1–6) 3.7 (2–7) 8.9 (6–18) 8.0 (4) 0.0 8.0 (4)

0.087 (Mann-Whitney U test) ⬍0.001 (Mann-Whitney U test) 1.000 (Mann-Whitney U test) 0.825 (Mann-Whitney U test) ⬍0.001 (Mann-Whitney U test) ⬍0.001 (Mann-Whitney U test) ⬍0.001 (Mann-Whitney U test) 0.708 (Fisher exact test)

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HAND ASSISTED LAPAROSCOPIC NEPHRECTOMY

time for the laparoscopic group was longer than for the open group, although this difference was not statistically significant (p ⫽ 0.087). To evaluate the impact of surgeon experience we divided our series, which involved a single surgeon, at the chronological midpoint of his experience, (September 21, 2001) and calculated mean operative time about this midpoint. For hand assisted laparoscopic surgery operative time decreased from a mean of 203 minutes for the first half to 187 minutes for the second half. The difference was not significant (p ⫽ 0.094). Mean specimen weight was not significantly different for the 2 groups. Estimated blood loss, mean number of days to the first postoperative oral feeding and mean duration of an indwelling drain in the laparoscopic group were significantly less than those in the open group, although there was no significant difference in the transfusion rate. In the laparoscopic group no conversions or reexplorations were required and no major complications occurred. However, 3 patients with ileus postoperatively were treated conservatively with intravenous hyperalimentation and drainage using a nasogastric tube, and they recovered completely. In the open group no major complications occurred but there were minor complications in 4. Two patients with ileus were treated conservatively. One patient had pneumothorax requiring chest tube placement and 1 had wound infection requiring wet-to-dry dressing for several days. To evaluate factors influencing operation time logistic regression analyses were performed. Univariate analysis indicated that sex was the only possible risk factor. ORs (95% CIs, between the high and low quartiles) for increased operative time were increased for male patients, namely 3.83 (95% 1.52 to 9.63) for the 104 who underwent radical nephrectomy and 16.00 CI (2.99 to 85.49) for the 54 who underwent laparoscopic surgery. Multivariate logistic regression was used to determine independent predictors of increased operative time. In the 104 patients who underwent radical nephrectomy sex was the only independent predictor. Male patients were at 4.1-fold risk (OR 4.14, 95% CI 1.42 to 12.02) of increased operative time compared with female patients. In the 54 patients who underwent laparoscopic surgery sex was

also the only independent risk factor. Male gender was associated with an increased likelihood of increased operative time compared with female patients (OR 12.90, 95% CI 1.86 to 89.23, table 3). We also evaluated the impact of sex on other variables, including operative and convalescence parameters for hand assisted laparoscopic surgery, because sex was an independent predictor of increased operative time. No significant differences were found for the other variables, namely age, body mass index, tumor side or diameter, ASA score, estimated blood loss or specimen weight, between male and female patients. DISCUSSION

Hand assisted laparoscopic procedures may provide potential benefits for experienced and inexperienced surgeons in terms of expanding the indications for laparoscopic surgery due to technical simplicity.13 The first case of hand assisted laparoscopic radical nephrectomy at our institute was performed on September 1999 and operative time was 310 minutes. Although the surgeon who performed the operation was an expert on open renal surgery, it was his first experience with laparoscopic surgery. Operative time in our next 3 cases was 250, 220 and 180 minutes, respectively, which shows that technical proficiency with hand assisted laparoscopic surgery is achieved quite rapidly and suggests that this technique is the more practical of the 2 approaches for urologists with limited experience with laparoscopic procedures. To our knowledge this series of 54 radical nephrectomies is the largest hand assisted laparoscopic radical nephrectomy series to date. Several series comparing hand assisted with standard laparoscopic9, 14 and open8, 11, 12 nephrectomy have been reported. A limitation of the previous series was that small sample sizes precluded the detection of slight differences between laparoscopy and open surgery, which is required to assess the usefulness of hand assisted laparoscopy for radical nephrectomy. In the current series the laparoscopic technique was not associated with significant intraoperative complications and, thus, there were no conversions to

TABLE 3. Multivariate logistic regression analysis of covariate influence on operation time greater than 180 minutes Laparoscopy ⫹ Open Surgery Adjusted OR (95% CI) Operation type: Open surgery Laparoscopy Surgeon experience: Half 1 Half 2 Sex: Female Male Age: 60 or Younger Older than 60 Tumor side: Rt Lt Tumor diameter (cm): 7 or Less Greater than 7 Body mass index (kg/m2): Less than 25.0 25.0 or Greater ASA score: 1 or Less Greater than 1 Estimated blood loss (cc): 200 or Less Greater than 200 Specimen wt (gm): 200 or Less Greater than 200

Laparoscopy p Value

Adjusted OR (95% CI)

p Value

0.114 1.00 2.33 (0.82–6.68) 0.068 1.00 4.70 (0.89–24.74) 0.009 1.00 4.14 (1.42–12.02)

0.010 1.00 12.90 (1.86–89.23)

0.988 1.00 0.99 (0.29–3.41)

0.994 1.00 1.01 (0.14–7.43)

0.603 1.00 1.29 (0.50–3.35)

0.526 1.00 0.59 (0.12–2.99)

0.816 1.00 0.81 (0.13–4.98)

0.865 1.00 1.26 (0.09–17.78)

0.429 1.00 1.53 (0.53–4.38)

0.393 1.00 2.16 (0.37–12.66)

0.791 1.00 0.87 (0.31–2.45)

0.617 1.00 1.50 (0.31–7.27)

0.236 1.00 1.96 (0.64–5.97)

0.936 1.00 1.08 (0.18–6.61)

0.250 1.00 1.79 (0.66–4.86)

0.515 1.00 1.78 (0.31–10.12)

HAND ASSISTED LAPAROSCOPIC NEPHRECTOMY

open surgery. In addition, the results presented confirm the advantages of hand assisted laparoscopic vs open radical nephrectomy. Okeke et al reported 3 major hand port wound complications in 13 patients with malignant disease of the kidney.15 However, the hand assistance device was placed in the lower quadrant medial to the anterior superior iliac supine in their series. In our series a vertical incision was made at the midline to attach the abdominal wall sealing device. We believe that the midline incision is less invasive because there is no muscle dividing, only muscle splitting. Interestingly we found that sex was the only independent risk factor for increased operative time. Female patients were associated with a decreased likelihood of increased operative time. However, we did not identify factors that influenced this result since no significant differences in the variables examined were found between male and female patients. It would seem that difficulty with dissecting stickier perinephric tissue in male patients may explain this finding but it can scarcely be quantified. A debate has arisen regarding the optimal approach required for this procedure since hand assisted laparoscopic surgery has inherent disadvantages. Although hand assisted laparoscopy results in lower morbidity than open surgery, it is inevitably associated with increased morbidity compared with pure laparoscopy. Convalescence may be prolonged as a result of the longer incision required, although Wolf9 and Slakey16 et al found that hand assistance did not alter convalescence significantly compared with standard laparoscopy. Also, intra-abdominal hand fatigue ranging from mild fatigue to severe cramping was noted in 21% of cases.17 Furthermore, the additional cost of the hand assistance device makes the procedure much more expensive. However, it has been argued that in addition to the cost savings obtained from decreased operative time, hand assisted laparoscopic surgery may decrease supply costs associated with the instruments required for standard laparoscopic surgery.10 In addition, hand assistance requires that the videoscope port must be placed suboptimally due to space constraints imposed by the PneumoSleeve base. However, the ultimate goal of minimally invasive surgery is to provide benefits equivalent to those of open surgery but that are associated with less morbidity. Using the hand assisted laparoscopic technique surgeons can maintain traditional skills associated with tactile sensation, while simultaneously making the transition from open to standard, pure laparoscopic surgery with greater ease.18 We have performed standard laparoscopic radical nephrectomy in several cases since October 2002 with favorable results. In a survey of laparoscopic practices performed in California urologists who used hand assisted devices tended to use it as a means of gaining familiarity with laparoscopic techniques.19 Furthermore, these urologists performed laparoscopic procedures more frequently than other urologists. We believe that, although hand assisted laparoscopy may not be the final goal, it can at least act as an educational bridge to minimal access surgery for the inexperienced laparoscopist. Potential limitations of the current study should be mentioned. The current series is sequential. Since improvements in outcomes such as hospital stay are more related to temporal improvements in inpatient care than to particular procedures, there is a trend toward decreasing hospitalization in general. Thus, this trend might account for some improvements in outcome in the laparoscopic group. CONCLUSIONS

Ease of learning is an important advantage to the novice laparoscopic surgeon. Urologists with minimal laparoscopic experience can perform hand assisted laparoscopy safely and

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efficiently. As in standard laparoscopy, the benefits of hand assisted laparoscopy compared with open surgery include better intraoperative and postoperative outcomes. In addition, this technique maintains the same oncological principles used in open surgery and allows the specimen to be removed en bloc. Although the current study was based on a retrospective and nonrandomized analysis, our findings suggest that hand assisted laparoscopic radical nephrectomy represents an effective, minimally invasive treatment option in patients with suspected renal cell carcinoma.

REFERENCES

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