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 ¤  Abstract
 ¤ Introduction
 ¤ Subjects and Methods
 ¤ Results
 ¤ Discussion
 ¤ Conclusions
 ¤  References
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 Table of Contents     
ORIGINAL ARTICLE
Year : 2019  |  Volume : 15  |  Issue : 1  |  Page : 14-18
 

Prospective analysis of laparoscopic versus open radical nephrectomy for renal tumours more than 7 cm


1 Department of Urology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh, India
2 Department of Urology, Apollo Main Hospital, Chennai, Tamil Nadu, India

Date of Submission07-Aug-2017
Date of Acceptance29-Dec-2017
Date of Web Publication4-Dec-2018

Correspondence Address:
Dr. Rajkumar Ashokkumar Patel
Department of Urology, Apollo Hospital, 21, Greams Lane, Off Greams Road, Thousand Lights, Chennai - 600 006, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jmas.JMAS_158_17

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 ¤ Abstract 

Aims: To analyse the feasibility of laparoscopic radical nephrectomy (LRN) for renal tumours >7 cm and to compare the operative and oncologic outcomes with open radical nephrectomy (ORN).
Settings and Design: This was a prospective, observational, comparative study.
Subjects and Methods: The study was conducted at a tertiary care super-speciality hospital. All the patients who underwent radical nephrectomy for >7 cm renal tumours during a period of 2 years (April 2012 to May 2014) were included in the study. Thirty patients were included in each ORN and LRN group. Pre-operative, intra-operative and post-operative data for all these patients were collected and analysed.
Statistical Analysis Used: Statistical Package for the Social Sciences (SPSS, version 11.0 for Windows, Chicago, IL).
Results: Mean age of patients in ORN and LRN groups was 57.3 ± 6.1 years and 54.9 ± 5.7 years, respectively (P = 0.220). As compared to ORN, LRN had less drop in post-operative haemoglobin (1.39 ± 0.55 g/dl vs. 4.07 ± 1.023 g/dl, P < 0.05), less drop in haematocrit value (4.7 ± 3.25% vs. 9.5 ± 5.13%, P < 0.05), less analgesic requirement for tramadol hydrochloride (165 ± 74.5 mg vs. 260 ± 181.66 mg) and less mean hospital stay (4.2 days vs. 6.1 days, P < 0.05). There was no statistically significant difference in post-operative complication rate and recurrence-free survival over a median follow-up of 17 months (93.9% – LRN vs. 90% – ORN)
Conclusions: LRN for large renal tumours is feasible and achieves oncologic outcomes similar to that obtained with ORN.


Keywords: Clinical stage T2 renal tumour, laparoscopic radical nephrectomy, renal cell carcinoma


How to cite this article:
Khan MM, Patel RA, Jain N, Balakrishnan A, Venkataraman M. Prospective analysis of laparoscopic versus open radical nephrectomy for renal tumours more than 7 cm. J Min Access Surg 2019;15:14-8

How to cite this URL:
Khan MM, Patel RA, Jain N, Balakrishnan A, Venkataraman M. Prospective analysis of laparoscopic versus open radical nephrectomy for renal tumours more than 7 cm. J Min Access Surg [serial online] 2019 [cited 2018 Dec 11];15:14-8. Available from: http://www.journalofmas.com/text.asp?2019/15/1/14/228404



 ¤ Introduction Top


Renal cell carcinoma (RCC) accounts for 2%–3% of all cancers in adults.[1] The incidence of RCC has increased over the past four decades because of more common use of ultrasound and computed tomography (CT) scan for the evaluation of various abdominal conditions.[2]

Radical nephrectomy is the gold standard treatment for localised RCC.[3],[4],[5] Clayman et al. first described laparoscopic radical nephrectomy (LRN) in 1991.[6] As urologists became more familiar with laparoscopy, LRN is now standard of care for small renal tumours (<7 cm) at most centres. Recent data suggest comparable oncological outcomes between ORN and LRN.

In our institution, we have been doing LRN for the past several years. We conducted this study in our institution to see the efficacy of LRN for large renal tumours (>7 cm) as compared to open radical nephrectomy (ORN).


 ¤ Subjects and Methods Top


This study was prospective, observational study conducted at our institute after prior approval from the Institutional Ethical Committee. All the patients who underwent radical nephrectomy for >7 cm renal tumours during a period of 2 years (April 2012 to May 2014) were included in the study. Patients having tumour thrombi involving renal vein or inferior vena cava (IVC), bulky lymphadenopathy, peri-renal extension and extensive involvement of adjacent structures were excluded from the study.

Basic work-up for major surgery was done, including haemoglobin (Hb), packed cell volume (PCV), total leucocyte count, platelet count, blood urea, serum creatinine, serum electrolytes and coagulation profile (bleeding time, clotting time, partial thromboplastin time [PTT] and activated PTT). All patients had contrast-enhanced CT scan of the abdomen-pelvis region pre-operatively. Metastatic workup included a chest radiograph and liver function tests. All patients were given choice of ORN versus LRN and explained pros and cons of both procedures. The surgical procedure was planned after patient's decision and informed consent.

All patients were operated under general anaesthesia with endotracheal intubation. Single shot of intravenous cefoperazone + sulbactam was given after negative test dose at induction of anaesthesia and antibiotics were continued for 48 h postoperatively. ORN was done with standard extra-peritoneal flank incision. LRN was done through transperitoneal approach with standard 3 or 4 port technique. Specimen was retrieved through iliac fossa/Pfannenstiel incision in endobag. Routine lymphadenectomy was not done. Adrenalectomy was done for upper polar tumours.

Total operative time (skin incision/creation of pneumoperitoneum to skin closure) was noted. All patients received injection tramadol hydrochloride three times a day for 24 h or longer depending on the case. Hb and PCV were measured on the 2nd post-operative day. Intra- and post-operative complications and hospital stay were recorded. Histopathological examination report was collected and histological type of tumour, grade and margin status were recorded.

On first follow up, patients underwent complete physical examination, abdominal CT scan, Chest radiograph (Chest CT scan, if any abnormality is found on radio-graph) and complete metabolic profile. Further follow up was individualized as per patient's need.

Statistical analysis was carried out using Statistical Package for the Social Sciences (SPSS, version 11.0 for Windows, Chicago, IL, USA). All the continuous data were expressed as mean ± standard deviation. The normality of the data was assessed by Shapiro–Wilk test.


 ¤ Results Top


Results are summarised in [Table 1] and [Table 2]. Intra-operative complications [Table 2] were similar in both the groups. One patient in each group had intra-operative haemorrhage which was managed with required intervention and did not required conversion in LRN group. One patient in each group had serosal bowel injury, which was treated with suturing.
Table 1: Results

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Table 2: Complications

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On histological examination, clear cell carcinoma was found to be the most common histological type in both ORN and LRN groups (90% and 83%, respectively). In both ORN and LRN groups, tumour grades were similar (P = 0.704). Most of the patients had Grade 2 (40% in ORN and 43.3% in LRN) or Grade 3 (53.3% in ORN and 50% in LRN).

In ORN group, two patients developed lung metastasis at 12th month of their follow-up and one patient developed liver metastasis at 18th month of his follow-up. In LRN group, two patients developed lung metastasis at 18th and 20th month of their follow-up (P = 0.601). There was no statistically significant difference between the two groups with respect to metastases.

Recurrence-free survival [Figure 1] was 90% in patients who underwent ORN and 93.3% in patients who underwent LRN (P = 0.630). There was no statistically significant difference in recurrence-free survival between two groups.
Figure 1: Kaplan–Meier recurrence-free survival curve

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 ¤ Discussion Top


The standard advantages of laparoscopy such as less blood loss, less pain, better cosmesis, lower analgesic requirement, shorter hospital stay and faster convalescence are achieved without sacrificing oncologic principles. For these reasons, LRN has become standard of care for renal masses <7 cm in size.

However, the role of laparoscopy in the management of large renal masses is not clearly established. With these concerns in our mind, we did a prospective observational study at our institute to check the feasibility and efficacy of LRN for >7 cm renal tumours and compared the operative and oncological outcomes with ORN.

In our study, there were no significant differences in both the groups in terms of age distribution, sex distribution, tumour size and tumour laterality. This is possibly due to small cohort size and defined inclusion/exclusion criteria. In fact, equal distribution of these factors has increased the validity of this study.

Steinberg et al. in their study found that estimated blood loss in ORN was 500 (range 100–3500) ml and in LRN group was 200 (range 50–1800) ml (P < 0.001).[7] Ganpule et al. in their study found that mean Hb drop in ORN group was 2.25 (range 0.2–7) g/dl and in LRN group was 1.55 (range 0.1–4.4) g/dl (P = 0.001).[8] In our study, patients were comparable with respect to pre-operative Hb levels in both the groups (P = 0.399). However, there was a statistically significant difference between post-operative Hb levels in both the groups (P < 0.005). In our study, mean Hb drop in patients who underwent ORN was 4.07 ± 1.023 g/dl and 1.39 ± 0.55 g/dl in patients who underwent LRN (P < 0.005). Similarly, in our study, mean haematocrit drop in patients who underwent ORN was 9.5 ± 5.13 and 4.7 ± 3.25 in patients who underwent LRN (P < 0.005). Blood loss was more in patients who underwent ORN as compared to those who underwent LRN. It is apparent that open approach in any surgery gives us better chance of tissue handling and application of haemostasis; however, from this study, we can conclude that meticulous dissection and less tissue handing in laparoscopic approach itself is beneficial in terms of blood loss.

In our study, LRN was associated with longer operative time than ORN (187.5 ± 48.49 vs. 163.6 ± 46.35) as was observed by Hemal et al. and Jeon et al.[9],[10] Longer operative time is associated with slow post-operative recovery due to prolonged anaesthesia, but the benefit of less blood loss and less pain usually compensates for better recovery in LRN group despite longer operative times.

Laparoscopic procedures need to be converted to open procedures due to technical difficulties, intra-operative complications and surgeon's inexperience in early learning curve. LRN is a relatively safe and technically uncomplicated procedure, provided that a surgeon has basic laparoscopic and anatomy knowledge. Meticulous dissection at hilum is the key to complete the procedure laparoscopically. In the study by Jeon et al., four cases in the LRN group required conversion to open procedure, three as a result of vascular injury and one because of mechanical trouble with CO2 gas insufflator.[10] Ritchie et al. in their study had 11% conversion rate in patients who underwent LRN for >7 cm renal tumours.[11] In our study, none of the patients in the LRN group required conversion to open procedure. Lack of conversion in our study is largely due to strict selection criteria, small cohort and surgeon's experience in laparoscopy.

Pain is the most common symptom for surgical patients and control of pain is the prime issue in the post-operative period. Use of non-steroidal anti-inflammatory drugs for pain relief in patients undergoing nephrectomy should be limited due to possibility of renal toxicity on single functioning kidney. Use of opioid analgesics is also associated with significant pharmacological side effects. In the study of Hemal et al., mean analgesic requirement (mg of morphine equivalent) in ORN group was 35 ± 8.01 and in LRN group was 16.4 ± 3.35 (P < 0.001).[9] In our study, mean analgesic (injection tramadol hydrochloride) requirement in patients who underwent ORN was 260 ± 181.66 mg and in patients who underwent LRN was 165 ± 74.5 mg (P = 0.001). LRN was associated with less post-operative pain, less analgesic requirement, less incidence of significant pharmacological side effects of analgesics drugs and hence better patient satisfaction and early ambulation.

The common intra-operative complication in ORN/LRN is vascular injury and bowel injury. Theoretically, transperitoneal laparoscopic approach has more chance of intra-abdominal organ injury, but it is compensated by better vision and increased laparoscopic experience at majority of the surgical centres all over the globe. Jeon et al. in their study found that intra-operative complications between ORN and LRN groups were not statistically significant (P = 0.349). Most common intra-operative complication in their study was haemorrhage in both the groups.[10] In our study, intra-operative complication rate was similar in ORN and LRN groups. In ORN group, one patient had IVC injury due to avulsion of gonadal vein which was managed by suturing the IVC wall with 6-0 prolene. One patient in ORN group had bowel injury (colonic serosal tear), which was managed by primary repair. In LRN group, one patient had bowel injury which was managed by intra-corporeal suturing and one patient had haemorrhage due to clip dislodgement from renal vein, but that was managed without conversion to open by re-application of Hem-o-Lok clip (Weck Closure Systems, Research Triangle Park, NC, USA). The conclusion is to stick to basic rule of minimal and necessary dissection, meticulous haemostasis and early identification of any complication if it happens.

Postoperative complication rate in ORN was 16.6%. Two patients had wound infection and one patient each had atelectasis, prolonged ileus and pneumothorax. In LRN group, two patients developed post-operative complication (atelectasis and wound infection in one patient each). In LRN group, although incidence of post-operative complications was less (6.6%), this did not achieved statistical significance (P = 0.644). The reason for statistical insignificance may be small cohort group. Other studies also noticed the same findings.[7],[9]

Mean hospital stay in our study was 6.1 days (range 4–11 days) for patients who underwent ORN and 4.2 days (range 3–8 days) for patients who underwent LRN. The day of surgery was considered as day 0, and the stay was calculated from day 0 to the day of discharge. There was statistically significant difference in hospital stay between the patients in both the groups (P < 0.005). Similar findings were found by Steinberg et al. and Hemal et al.[7],[9]

Median follow-up was 17 months for patients in ORN group and 17.5 months for patients in LRN group (P = 0.847). During follow-up in our study, three patients in ORN group developed distant metastases. Out of three, two patients were noted to have lung metastases at 12th month of their follow-up and one patient developed liver metastasis at 18th month of his follow-up. Two patients in LRN group developed lung metastases at 18th and 20th month of their follow-up, respectively. There was no statistically significant difference between the groups in disease recurrence (P = 0.630). We did not found any local recurrence on follow-up in either group. In the study by Hemal et al., mean follow-up was 57.2 and 51.4 months for patients in ORN and LRN groups, respectively. They observed distant metastases in 9.85% of patients in ORN group and 7.3% in LRN groups (P = 0.91).[9]

Recurrence-free survival in our study was 90% in patients who underwent ORN and 93.3% in patients who underwent LRN (P = 0.630) [Figure 1]. There was no statistically significant difference in recurrence-free survival between the two groups. Kwon et al. noticed 5-year recurrence-free survival of 85.7% and 84.8% (P = 0.842) in ORN and LRN groups respectively.[12] In the study by Hemal et al., 5-year recurrence-free survival was 90.1% and 92.6% (P = 0.91) in ORN and LRN groups, respectively.[9] Jeon et al. observed 2-year recurrence-free survival of 93.7% and 90.1% in ORN and LRN groups, respectively.[10]

As none of our patients died during the study period, we could not calculate cancer-specific survival. In our study, overall survival was 100% for both the groups. The reason for this is the short follow-up of our study. This may be the limitations of our study.


 ¤ Conclusions Top


LRN for large renal tumours is feasible and achieves the oncologic outcomes similar to that obtained with ORN with the added advantage of better cosmesis, less pain, less blood loss and lower analgesic requirement. Although LRN for large renal tumours is associated with longer operative time than ORN, it is compensated by shorter hospital stay and convalescence time.

Acknowledgements

We are thankful to Mr. Balasubramaniam a chief statistician at our institute for his immense help in data analysis.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
 ¤ References Top

1.
Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010;60:277-300.  Back to cited text no. 1
    
2.
Chow WH, Devesa SS, Warren JL, Fraumeni JF Jr. Rising incidence of renal cell cancer in the United States. JAMA 1999;281:1628-31.  Back to cited text no. 2
    
3.
Ljungberg B, Cowan NC, Hanbury DC, Hora M, Kuczyk MA, Merseburger AS, et al. EAU guidelines on renal cell carcinoma: The 2010 update. Eur Urol 2010;58:398-406.  Back to cited text no. 3
    
4.
Subotic S, Wyler S, Bachmann A. Surgical treatment of localized renal cancer. Eur Urol 2012;11:60-5.  Back to cited text no. 4
    
5.
Campbell SC, Lane BR. Malignant renal tumors. In: Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peter CA, editors. Campbell-Walsh Urology. 10th ed. Philadelphia: Saunders Elsevier; 2012. p. 1420.  Back to cited text no. 5
    
6.
Clayman RV, Kavoussi LR, Soper NJ, Dierks SM, Meretyk S, Darcy MD, et al. Laparoscopic nephrectomy: Initial case report. J Urol 1991;146:278-82.  Back to cited text no. 6
    
7.
Steinberg AP, Finelli A, Desai MM, Abreu SC, Ramani AP, Spaliviero M, et al. Laparoscopic radical nephrectomy for large (greater than 7 cm, T2) renal tumors. J Urol 2004;172:2172-6.  Back to cited text no. 7
    
8.
Ganpule AP, Sharma R, Thimmegowda M, Veeramani M, Desai MR. Laparoscopic radical nephrectomy versus open radical nephrectomy in T1-T3 renal tumors: An outcome analysis. Indian J Urol 2008;24:39-43.  Back to cited text no. 8
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9.
Hemal AK, Kumar A, Kumar R, Wadhwa P, Seth A, Gupta NP, et al. Laparoscopic versus open radical nephrectomy for large renal tumors: A long-term prospective comparison. J Urol 2007;177:862-6.  Back to cited text no. 9
    
10.
Jeon SH, Kwon TG, Rha KH, Sung GT, Lee W, Lim JS, et al. Comparison of laparoscopic versus open radical nephrectomy for large renal tumors: A retrospective analysis of multi-center results. BJU Int 2011;107:817-21.  Back to cited text no. 10
    
11.
Ritchie RW, Sullivan ME, Jones A. Laparoscopic radical nephrectomy for T2 renal cell carcinoma. Br J Med Surg Urol 2009;2:117-23.  Back to cited text no. 11
    
12.
Kwon SY, Jung JW, Kim BS, Kim TH, Yoo ES, Kwon TG, et al. Laparoscopic versus open radical nephrectomy in T2 renal cell carcinoma: Long-term oncologic outcomes. Korean J Urol 2011;52:474-8.  Back to cited text no. 12
    


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    Tables

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