Hand-assisted laparoscopy for large renal specimens: a multi-institutional study

Material and methods 

Between March 1998 and October 2000, more than 200 HAL nephrectomies were performed at three institutions. Of the 200 patients, 106 underwent HAL radical nephrectomy, as previously described,8 for enhancing renal masses. For patients with large upper pole renal masses, the radical nephrectomy specimen included the ipsilateral adrenal gland.

We retrospectively and prospectively reviewed the patients’ medical records and chart notes. The demographic data included age, American Society of Anesthesiologists classification, and body mass index (BMI). Those patients with a BMI of 31 or greater were considered obese. The intraoperative parameters included operating room time (skin incision to closure), estimated blood loss, and change in hematocrit (preoperative hematocrit minus discharge hematocrit). The postoperative parameters included time to oral intake (in days), parenteral narcotic requirements (in milliequivalents of morphine sulfate), oral narcotic requirements (in number of tablets), and length of hospital stay (in days). The minor and major complications were recorded. The pathologic specimens were analyzed in terms of cell type, tumor grade, tumor stage, specimen weight, and presence of positive margins. The follow-up evaluations included, at a minimum, physical examination, chest x-ray, and blood work at 3-month intervals and physical examination, chest x-ray, blood work, and computed tomography of the abdomen and pelvis at 12 months postoperatively. The time of follow-up was recorded for all patients, as was evidence of local recurrence and/or metastatic disease. Finally, using both telephone interviews and chart reviews, the time of convalescence was determined for all patients. The convalescence time was defined as the number of days required for patients to return to work and/or fully participate in all preoperative activities, including exercise.

Of the 106 patients, 95 were assessable with complete preoperative, intraoperative, and postoperative data. We categorized these patients according to tumor size (7 cm or greater versus less than 7 cm) and BMI (31 or greater versus less than 31). In addition, we subcategorized those subjects with masses greater than 7 cm into those with lesions 7 to 10 cm and greater than 10 cm to evaluate any differences. We compared all endpoints to determine the effect of tumor size and BMI on HAL nephrectomy. We used a two-tailed Student’s t test and the chi-square test to make comparisons.

Results 

Of the 95 patients, 32 underwent HAL for large tumors (7 cm or greater) and 63 had tumors less than 7 cm. When we subcategorized the 32 patients with masses greater than 7 cm, 23 had masses of 7 to 10 cm and 9 had masses greater than 10 cm. Forty-one patients undergoing HAL were obese (BMI greater than 31) and 54 were not (BMI less than 31). The demographic data are summarized in Table I. The only statistically significant difference was that the American Society of Anesthesiologists class was higher among obese patients than among those with a BMI less than 31.

TABLE I. Demographic data

		Tumor Size (cm)		BMI
		<7 (n = 63)	≥7 (n = 32)	<31 (n = 54)	≥31 (n = 41)
	Age (yr)	62 ± 14	60 ± 12	61 ± 15	62 ± 12
	Sex (M/F)	34/29	21/11	29/25	26/15
	BMI	30 ± 6	33 ± 1.9	28 ± 2.7	35 ± 5*
	ASA	2.1 ± 0.6	2.3 ± 0.7	2.0 ± 0.6	2.3 ± 0.7*

Key: BMI = body mass index; M/F = male/female; ASA = American Society of Anesthesiologists.

* P <0.05.

The intraoperative parameters are summarized in Table II. The only statistically significant finding was that obese patients had longer operating room times compared with patients with a BMI less than 31 (214 versus 176 minutes). No differences were found in patients who underwent HAL for lesions greater than 7 cm and those with lesions less than 7 cm. However, when subgrouping large renal tumors, patients with masses greater than 10 cm had significantly longer operative times statistically compared with those with masses 7 to 10 cm (198 versus 243 minutes, respectively). No difference was found in any of the groups in terms of estimated blood loss, intraoperative complications, or conversions.

TABLE II. Intraoperative parameters

	Parameter	Tumor Size (cm)		BMI
		<7 (n = 63)	≥7 (n = 32)	<31 (n = 54)	≥31 (n = 41)
	Left/right	26/37	14/18	26/28	14/27
	OR time (min)	138 ± 76.5	198 ± 61.7	176 ± 63	214 ± 78*
	EBL (mL)	109 ± 130	167 ± 197	105 ± 127	158 ± 189
	Conversions (n)	1 (1.5)	2 (6)	1 (1.8)	2 (4.8)

Key: BMI = body mass index; OR = operating room; EBL = estimated blood loss. Numbers in parentheses are percentages.

* P <0.05.

Postoperatively, patients with large tumors and obese patients had similar lengths of stay, narcotic requirements, changes in hematocrit, and complications compared with their counterparts (Table III). The only statistically significant difference was that the mean time to convalescence was 2.5 days longer in patients with large renal masses and those who were obese.

TABLE III. Postoperative parameters

	Parameter	Tumor Size (cm)		BMI
		<7 (n = 63)	≥7 (n = 32)	<31 (n = 54)	≥31 (n = 41)
	LOS (days)	3.7 ± 1.3	3.7 ± 1.2	3.6 ± 1.4	3.7 ± 1.1
	Parenteral narcotics (mg MSO4)	36 ± 24	31 ± 22	35 ± 24	34 ± 23
	Oral narcotics (tablets)	6 ± 5	5.5 ± 5	6 ± 5	5.8 ± 5
	Hct change	4.7 ± 3.4	4.3 ± 2.1	4.9 ± 3.4	3.9 ± 1.8
	Complications (%)	6 (9)	4 (12.5)	5 (9)	5 (12)
	Convalescence (days)	18 ± 5	21 ± 6*	17.5 ± 5	21 ± 6*

Key: BMI = body mass index; LOS = length of stay; MSO4 = morphine sulfate; Hct = hematocrit. Numbers in parentheses are percentages.

* P <0.05.

No difference was found in the incidence of minor or major complications between the groups. Four major complications occurred: one intraoperative caval injury repaired laparoscopically, one small bowel obstruction requiring exploration on postoperative day 10, one pneumonia, and one delayed ileus requiring readmission on postoperative day 10. Seven minor complications occurred: three wound infections, 2 patients with a prolonged ileus (requiring prolonged observation), one seroma (requiring drainage), and one reducible incisional hernia at the extraction site.

The pathologic findings are summarized in Table IV. The specimen weight was largest in patients with tumors of 7 cm or greatest and in obese patients and varied from 331 to 1700 g. The largest kidney removed had a tumor of 14 cm in diameter. Most tumors were renal cell carcinoma (89%). Other tumors included sarcoma, oncocytoma, angiomyolipoma, and complex cyst. As expected, the tumor stage increased as the tumor size increased.

TABLE IV. Pathologic characteristics

	Characteristic	Tumor Size (cm)		BMI
		<7 (n = 63)	≥7 (n = 32)	<31 (n = 54)	≥31 (n = 41)
	Average tumor size (cm)	4.2 ± 1.4	8.9 ± 2.2*	4.4 ± 1.4	7.61 ± 3
	Average tumor weight (g)	405 ± 258	647 ± 287*	556 ± 225	680 ± 275
	Pathologic finding (n)
	Renal cell carcinoma	57 (90)	28 (88)	48 (88)	37 (90)
	Sarcoma	0 (0)	2 (6)	0 (0)	2 (7)
	Oncocytoma	4 (6)	2 (6)	5 (9)	1 (3)
	AML	1 (2)	0 (0)	1 (3)	0 (0)
	Complex cyst	1 (2)	0 (0)	0 (0)	1 (3)
	Stage of renal cell (n)
	T1	50 (88)	0 (0)	31 (65)	19 (51)
	T2	4 (7)	16 (57)	8 (16)	12 (33)
	T3	3 (5)	12 (43)	9 (19)	6 (16)
	N1 or M1	1 (1.5)	1 (3.5)	0 (0)	2 (5)
	Mean follow-up (mo)	12.4 ± 7.5	13.2 ± 8.2	12.7 ± 8.6	13.1 ± 9.1
	Recurrence (n)	1	1	0	2

Key: BMI = body mass index; AML = angiomyolipoma. Numbers in parentheses are percentages.

* P <0.05.

The follow-up was relatively short, averaging 12 months. One metastatic recurrence developed in a patient with a 4.5-cm pathologic T3, grade 3, clear cell carcinoma. One local recurrence developed in a patient with pathologically confirmed sarcoma. This was the only patient, of 95, who had had a positive margin.

Comment 

One of the potential drawbacks of standard laparoscopy is the inability to manage large lesions. In terms of the retroperitoneal approach, Abou et al.9 recommended treating tumors no larger than 5 cm because of the limited working space afforded by this technique. Dunn et al.6 reported that laparoscopic radical nephrectomy may be safely performed in patients with tumors of 10 cm or less. Gill et al.10 suggests that laparoscopic nephrectomy may be safely performed in lesions up to 10 to 12 cm. As such, no general agreement exists on what the upper limit should be for lesions removed laparoscopically. However, it is clear that many investigators consider large lesions a relative contraindication. Chan et al.11 recently compared laparoscopic versus open radical nephrectomies at two institutions and found no significant difference in survival data. However, most (79%) of their laparoscopic patients had clinical Stage T1 disease, and the mean specimen size of all lesions removed laparoscopically was 5.1 cm.

From a technical standpoint, HAL allows the surgeon to remove large renal masses safely and reproducibly. No statistically significant differences in operating room time, estimated blood loss, conversion rate, complication rate, narcotic requirement, or length of stay was noted for large versus small renal masses. However, patients with tumors greater than 10 cm had operative times on average 45 minutes longer. Postoperatively, the only statistically significant difference between the two groups was in convalescence. Patients with large renal masses took 2.5 days longer to return to normal activities; although statistically significant, we do not believe this to be a clinically significant finding.

From an oncologic standpoint, HAL does not appear to compromise cancer control in patients with large or small renal masses. The positive margin, local recurrence, and metastatic rates were similar between both cohorts. Although our follow-up was short (12 months), the long-term data available from other large multi-institutional studies examining cancer control rates of laparoscopic radical nephrectomy suggest it is similar to open radical nephrectomy. Cicco et al.3 recently published their retroperitoneal laparoscopic nephrectomy series. Of 41 radical nephrectomies with a mean follow-up of 24.9 months, no trocar site recurrences and only one local recurrence in a patient with a Stage pT3 tumor developed. Cadeddu et al.1 also reported similar data among 151 patients who underwent laparoscopic radical nephrectomy. They reported no trocar site recurrences in patients followed up for a mean 19.2 months. Four patients developed metastatic disease and one developed a local recurrence. Furthermore, the 5-year actuarial disease-free rate for all patients with clinical T1-T2,N0,M0 disease was 91%.

Several studies have examined the use of laparoscopy in obese patients. Fazeli-Matin et al.12 reported that obese patients undergoing laparoscopic renal or adrenal surgery have less blood loss, a quicker return of bowel function, less analgesic requirement, shorter convalescence, and a shorter length of stay than do obese patients undergoing standard open surgery. Mendoza et al.13 reported the complications associated with different laparoscopic procedures in morbidly obese patients and found the incidence of complications was significantly higher than in the general population undergoing laparoscopic surgery. Jacobs et al.14 reported their laparoscopic donor nephrectomy series of 431 patients, with 41 patients who were morbidly obese. Donor operations were a mean of 40 minutes longer in their obese group. Furthermore, the obese patients required more and larger laparoscopic ports and were more likely to require conversion to open nephrectomy. Doublet and Belair15 reported a similar complication rate for obese and nonobese patients undergoing retroperitoneal laparoscopy. However, in their series of 55 retroperitoneal laparoscopic nephrectomies, only 11 were performed for suspected renal carcinoma; most were performed for small, nonfunctioning kidneys.

In our series, obese patients undergoing HAL radical nephrectomy required an average of 40 minutes longer to complete but had similar estimated blood losses, complication rates, conversion rates, lengths of stay, and narcotic requirements as patients who were not obese. Similarly, Hedican et al.16 retrospectively reviewed the complications associated with 196 consecutive patients who underwent HAL and found no difference in complications between obese and nonobese patients. This suggests that HAL nephrectomy is not only safe and reproducible for obese patients with malignant tumors but may offer distinct advantages compared with standard laparoscopy.

The theoretical advantages of HAL for large renal masses and obese patients are many. The hand in the operative field allows for excellent retraction, maneuverability, and safer dissection with increased vascular control. If bleeding is encountered, control can be easily obtained by manually compressing the vessel, as in open surgery. In addition, one or more large laparotomy pads may be introduced to pack an area that is bleeding while the remaining dissection continues. Finally, once the kidney is completely freed, the hand incision placed at or below the umbilicus at the start of the case provides an extraction site for en bloc removal of the specimen. Although the incision length was not routinely recorded, we noted anecdotally that the hand incision often had to be extended to remove the larger specimens.

HAL has some disadvantages compared with standard laparoscopic surgery. In very small patients or those with very muscular abdominal walls, the working space may be limited by placing the hand into the intra-abdominal cavity. Also, the extraction site is limited to where the surgeon initially places the HandPort. Therefore, it may not be as cosmetically pleasing, especially for left renal masses in which the hand port is placed periumbilically. Another theoretical disadvantage of HAL is that it uses a transperitoneal approach, requiring mobilization of intra-abdominal organs, which may lead to inadvertent injury. Retroperitoneal laparoscopy does not.

Finally, one inherent weakness of our method was the evaluation of convalescence. Data regarding this endpoint was established retrospectively using chart reviews and telephone interviews. Since 2002, we have begun using prospective, validated, self-administered questionnaires to record this endpoint.

Conclusions 

HAL provides a safe, reproducible, and minimally invasive technique to remove large renal specimens, including tumors greater than 7 cm and renal tumors in the obese. There is no evidence that oncologic principals are compromised with this technique, irrespective of the size of the lesion or body habitus. Although some statistically significant differences in terms of operating time and convalescence were noted, the clinical significance was negligible. The estimated blood loss, change in hematocrit, time to oral intake, length of stay, narcotic requirement, and complication incidence were similar, irrespective of tumor size or body habitus.