|Year : 2001 | Volume
| Issue : 1 | Page : 14-19
A prospective randomized trial of open surgery versus endourological stone removal in patients of staghorn stones with chronic renal failure
Anant Kumar, Balbir S Verma, Sanjay Gogoi, Rakesh Kapoor, Aneesh Srivastava, Anil Mandhani
Department of Urology & Renal Transplantation, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India
Department of Urology & Renal Transplantation, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow -226014
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Introduction: Renal stones with chronic renal failure (CRF) is a complex problem due to various inherent problems associated with CRP. Treating these stones is a challenge and therapy has to be tailored accordingly. Although there are many studies in the literature regarding the optimum management of staghorn stones with Percutaneous Nephrolithotomy (PCNL) alone or in combination with Extracorporeal Shock Wave Lithotripsy (ESWL); but the issue of staghorn stones with associated CRF has not been addressed adequately till date. Current study compares the role of open surgery vs PCNL in staghorn renal stones with CRF.
Material and Methods: 26 patients with staghorn renal calculi and CRF were randomized to open (group I) and PCNL (group II) groups. The pre and postoperative hemoglobin (HB), hematocrit (HCT), serum creatinine and urine culture, size of stones, intraoperative blood loss, number of transfusions, surgical complications and duration of procedure was documented. Hemodialysis was done as and when necessary. The residual stone in both groups were treated with ESWL. Hospital stay and overall cost of treatment were analyzed.
Results: A total of 10 patients were randomized to group I and 16 patients to group II (18 males and females). The two groups were comparable in terms of age (43.1 ± 13.9 vs 53.0 ± 15.5 yrs), preoperative serum creatinine (380.1 ± 247.5 vs 327.1 ± 88.4 pmol/L), Hb (88.0 ± 24.0 vs 95.0 ± 24.0 gm/L) and HCT (28.9 ± 7.9% vs 30.4 ± 7.3%). Stone size was 1713 ± 1470.2 and 1675 ± 2737.5 mm2 in group I and group 11 respectively. Preoperative culture was positive in 70% of open and 30% of PCNL group. The operating time (1160 ± 44.0 vs 152.5 ± 53 mins), and complication rate (10%in each) were similar in group 1 and group II respectively. Intraoperative blood loss was more in group II but it did not reach statistical significance. 1 patient in group I and 4 in group II required blood transfusion. The average number of sittings required in PCNL was 1.7 ± 0.67 with a puncture rate of 1.9 ± 0.73 per patient. Postoperative Hb, HCT, serum creatinine, bleeding, collections and fever were comparable in the two groups. Overall stone clearance (after adjuvant ESWL) was better in open (80%) as compared to PCNL (62.5%) group. The overall cost of treatment was significantly lower in open (Rs. 8333.3 ± 2851.3) as compared to PCNL (Rs. 16940 ± 4171.9). Hospital stay in the two groups was comparable (12.6 ± 6.1 and 12.9 ± 4.1 days in open and PCNL respectively).
Conclusion: In view of the better clearance rate and lesser cost of treatment, open surgery still has a place in the management of staghorn stones with chronic renal failure even in a tertiary urological center. However postoperative pain and a larger scar cannot be ignored.
Keywords: Chronic Renal Failure; Staghorn Calculi.
|How to cite this article:|
Kumar A, Verma BS, Gogoi S, Kapoor R, Srivastava A, Mandhani A. A prospective randomized trial of open surgery versus endourological stone removal in patients of staghorn stones with chronic renal failure. Indian J Urol 2001;18:14-9
|How to cite this URL:|
Kumar A, Verma BS, Gogoi S, Kapoor R, Srivastava A, Mandhani A. A prospective randomized trial of open surgery versus endourological stone removal in patients of staghorn stones with chronic renal failure. Indian J Urol [serial online] 2001 [cited 2019 Oct 18];18:14-9. Available from: http://www.indianjurol.com/text.asp?2001/18/1/14/37373
| Introduction|| |
Management of staghorn calculi in Chronic Renal Failure (CRF) is a daunting task due to various inherent problems associated with CRF like anemia, coagulation defects, poor fluid and electrolyte balance, poor wound healing and weak immunological status. Although there are many studies in the literature regarding the optimum management of staghorn stones with Percutaneous Nephrolithotomy (PCNL) alone or in combination with Extracorporeal Shock Wave Lithotripsy (ESWL) yet the issue of management of staghorn stones with renal failure has not been addressed adequately till date.
Advances in ESWL and expertise in endourological procedures, have diminished the role of open surgery in the management of patients with renal and ureteral calculi. The indications for open surgery in the 1990s include complex stone burden, failure of ESWL or endourological treatment, anatomic abnormalities such as infundibular stenosis, renal calyceal diverticulum or concomitant ureteropelvic junction obstruction requiring surgery and morbid obesity.
As compared to staghorn with normal renal function, patients with associated CRF are logically more prone to bleeding diathesis and septicemia due to infected stones. Fluid overload is another potential problem restricting the intraoperative irrigation time during PCNL. This leads to more number of sittings for PCNL and increases the morbidity and the overall cost of treatment significantly.
Open surgery therefore appears to be a valid option in such cases. The residual calculi can be treated by minimal use of ESWL thus reducing the overall cost of treatment, which is a major concern in the scenario of a developing country. The current randomized prospective study was undertaken to compare the efficacy, safety and cost effectiveness of open surgery vs PCNL in the management of staghorn stones with CRF.
| Materials and Methods|| |
26 patients with staghorn renal calculi and CRF were randomized to undergo open surgery (group I) and PCNL (group II). Patients were informed about the pros and cons of both procedures and those who agreed to randomization were included after obtaining an informed written consent. Enrollment took over two years as many patients were reluctant to undergo open surgery and elected for PCNL and hence were opted out of the study.
All patients included in the study had complete staghorn stones with serum creatinine of more than 221 pmol/L (normal 44.2 to 132.6 µcool/L). In the open surgery group 9 patients underwent extended Pyelolithotomy and one had two radial nephrotornies in addition to extended pyelolithotomy. Pre- and postoperative hemoglobin (HB), hematocrit (HCT), and urine culture were recorded. Serum creatinine was estimated preoperatively and just before discharge of patient from the hospital. The size of the stone, intraoperative blood loss, number of transfusions, surgical complications and the duration of the procedure were documented. Hemodialysis was done as and when necessary. The residual stones in both groups were treated with ESWL. Hospital stay and the overall cost of the treatment were analyzed.
| Results|| |
Of the total 26 patients, 10 were randomized to group I and 16 patients to group II (18 males and 6 females). The two groups were comparable in terms of age (43.1 ± 13.9 vs 53.0 ± 15.5 yrs). preoperative serum creatinine (380.1 ± 247.5 vs 327.1 ± 88.4 umol/L), Hb (88.0 ± 24.0 vs 95.0 ± 24.0 gm/L) and HCT (28.9 ± 7.9 % vs 30.4 ± 7.3 %).
The stone size in the open group was 1713 ± 1470.2 and that in the PCNL group was 1675 ± 2737.5 mm2 Preoperative culture was positive in 70% of open and 30% of PCNL group. The operating time was 1160 ± 44.0 vs 152.5 ± 53 mins and intraoperative blood loss 255 ± 313 vs 448 ± 185.9 ml respectively in group I and II. [Table - 1]
The number of sittings required in PCNL was 1.7 ± 0.67 and the average number of punctures was 1.9 ± 0.73 per patient. 2 patients in the PCNL group had intraoperative complications (1 hydropneumothorax and 1 severe hemorrhage leading to abandoning of the procedure) whereas there was no major intraoperative complication in the open group [Table - 2]. Intraoperative blood transfusion was required in 43.75% of PCNL patients (mean 1.5 units per patients) whereas only one patient required blood transfusion in the open surgery group. The fall in hemoglobin (15.6 ± 22.8 gm/L in open vs 18.3 ± 26.2 gm/L in PCNL) and hematocrit (4.7 ± 6.27% in open vs 6.58 ± 5.03% in PCNL) after surgery was comparable in the two groups. 1 patient in the open group had collection requiring drainage whereas there was no significant postoperative collection in PCNL group.
Postoperative fever (for >48 hours) was documented in 20% in open group and 40% of PCNL patients. Postoperative culture was positive in 20% of open and 40% of PCNL patients. Postoperative Hb, HCT and bleeding were comparable in two groups [Table - 3]. Postoperative serum creatinine levels in the two groups were comparable (274.0 ± 141.4 umol/L in group I vs 291.7 ± 106.1 pmol/L in group II).
At the end of the monotherapy 70% of patients were stone free in the open group whereas only 56.25% were stone free in the PCNL group (after an average of 1.7 ± 0.73 sittings) [Figure - 1]. All the residues (n = 10; 3 open group and 7 PCNL group) were subjected to ESWL. 2/10 of residual stones (one each in open and PCNL group) cleared completely after ESWL. Remaining patients had insignificant acceptable residue. So the overall stone free rate after adjuvant ESWL was 80% in open and 62.5% in PCNL group.
The cost of treatment at the end of monotherapy was significantly lower in open surgery compared to PCNL (Rs 8333.3 ± 2851.3 in open vs Rs 16940 ± 4171.9 in PCNL). The overall cost of the treatment including adjuvant ESWL was still more expensive in PCNL group than the open surgery (Rs 8453 ± 2743.2 in open vs 19940 ± 4161.5 in PCNL). Hospital stay in the two groups was comparable (12.3 ± 6.1 days in open vs 12.9 ± 4.1 days in PCNL).
| Discussion|| |
The role of open surgery has decreased considerably in the modern era of minimally invasive surgery, but it needs consideration in CRF patients due to associated co-morbid conditions and inherent problems. The review of literature of the last 25 years did not reveal any study comparing open surgery to PCNL in staghorn renal calculi with CRF. Gupta et al (1994) reported 33 patients with CRF in a series of 2000 patients with urolithiasis (incidence 1.65%) of which 25 had staghorn calculi (64%). 8/21 had bilateral staghorn calculi. 7 patients required only a single procedure (4 ESWL and 3 PCNL), one patient was managed with alkalization alone. Remaining 25 patients required 36 sessions of PCNL, 4 ureteroscopic stone extraction, 39 ESWL sessions and 8 open procedures (average 3.5 sessions per patient). They however did not mention the success and complication rate of open surgery and PCNL.
Brannen et al (1985) compared PCNL (250) and surgical lithotomy (100 patients). With PCNL, targeted calculi were removed successfully in 97% of cases and the success rate of open surgery was 96%. Complication rate and anesthesia time (159 ± 4 min in PCNL vs 193 ± 8 min in open) were comparable in two groups. Hospital stay 5.5 + 0.3 days for PCNL and 8.4 ± 0.5 days for open surgery (p<0.001). Cost of treatment averaged $ 7203 ± 55 for PCNL and $ 8849 ± 660 for open surgery (p<0.01). PCNL resulted in rapid convalescence and diminished pain compared to open surgery. But this study did not mention the stone size. All patients had normal renal function. Moreover they did not mention the number of sittings required per patient in the PCNL group. Success rate has been described in terms of removal of targeted stones and not complete clearance.
Snyder et al (1986) compared the procedure time, success rates, complications and recovery time for PCNL (75 cases) and anatrophic nephrolithotomy (25 cases) in patients with staghorn calculi. The frequency of residual stones was higher in PCNL than anatrophic nephrolithotomy (13.3% in PCNL vs 0.0% in anatrophic nephrolithotomy). Procedure time was shorter (155.1 minutes in PCNL vs 266.5 minutes in anatrophic nephrolithotomy), and the need for blood transfusion was lesser (average 2 units in 53% of PCNL and 3.5 units in 70% of open surgery) and return to work was much more rapid (14.3 days in PCNL vs 53.3 days in open after discharge from the hospital) after PCNL. In this series all the patients had normal renal function and there is no mention about the number of sittings of PCNL required per patient.
Kahnoski et al (1986), while comparing the results of combined PCNL + ESWL with anatrophic nephrolithotomy in staghorn renal calculi had found residual stones in 15% of patients treated with PCNL + ESWL. But the morbidity of the combined approach was less than that of anatrophic nephrolithotomy. This study also had patients with normal renal function and the cost of treatment was not analyzed.
DiSilverio et al (1990) treated 269 patients of staghorn calculi. 56% patients underwent ESWL monotherapy, 28% PCNL + ESWL and 16% open surgery. Clearance rate was 78% with ESWL, 81 % with PCNL + ESWL and 83% with open surgery. Blood transfusion was required in 5.2% of PCNL + ESWL and 29% of open surgery group. Post procedure fever occurred in 45% of ESWL, 55% of PCNL + ESWL and 29% of open surgery group. Mean cost of treatment was $ 3957 for ESWL (mean hospital stay 12 days), $ 5565 for PCNL + ESWL (mean hospital stay 20 days) and $ 3230 in open surgery (mean hospital stay 14 days). Renal function in all the patients was normal.
The nephrolithiasis Clinical Guideline Panel (Segura et al, 1994) reported lower stone free rate following PCNL monotherapy for staghorn renal calculi. But at the same time they found impairment of renal function in patients having had open surgery.
In the current study, out of 560 patients treated for urolithiasis between March 1997 and May 2000, there were 26 patients with CRF (incidence 4.6%). The probable reason for high incidence of CRF (compared to the series of Gupta et al''-) in our patients is the neglected stone disease due to poverty, ignorance, illiteracy and inadequate medical facilities in rural areas and smaller towns. Most of these patients try alternate medical therapy (Ayurveda and Homeopathy) before undergoing surgery. Apart from serum creatinine, no other functional study was performed preor postoperatively in this series. In renal failure secondary to stone disease, it is very difficult to estimate renal function unless obstructive stone and concurrent infection is taken care of. Differential GFR with 99Tc DTPA renal scan is unreliable and MAG-3 is not widely available. In developing countries, we try to remove stones in renal failure with the hope to relieve obstruction and infection that might improve or stabilize the renal function as renal replacement therapy is not widely available and is very expensive. All published series fail to identify the patients who will improve with stone removal. So it is better to give benefit of doubt to these patients. Even if the function gets stabilized and the patient gets 2-3 years of dialysis-free time, it is worth trying.
All 10 patients in open group had only one invasive procedure whereas 16 patients in PCNL group underwent 26 sessions of PCNL (1.63 ± 0.72 sessions per patient) with a puncture rate of 1.9 ± per patient. After monotherapy the rate of clearance in the current study with open surgery (70%) was significantly better than that of PCNL group (56.25%). This lower stone clearance rate after PCNL is in agreement with the report of Nephrolithiasis Clinical Guideline Panel. The overall stone free rate even after adjuvant ESWL was much better in open surgery group (80% vs 62.5% in open and PCNL respectively). In contrast to the finding of the Nephrolithiasis Clinical Guideline Panel, the current study showed that the postoperative serum creatinine was comparable in the two groups suggesting that the concern for renal impairment following open stone surgery was unfounded. The cost of PCNL monotherapy was much higher than the open surgery [Figure - 2]. The explanation of this higher cost is the additional expenses incurred due to the multiple sittings in PCNL group. ESWL for the residual stones further added to the overall cost. One possible cause for multiple sittings is problem of fluid overload in patients with compromised renal function compelling the surgeon to abandon the procedure earlier than in PCNL under normal circumstances. If we look at the pre- and postoperative rate of infection (culture positive) and the incidence of postoperative fever [Figure - 3], there is a clear indication that the intraoperative irrigation during PCNL leads to much higher rate of bacteremia and postoperative infection as compared to open surgery. Some of these staghorn stones harbor bacteria in the stone lattice, which cannot be sterilized.
This small study clearly indicates that in the setting of staghorn calculi with CRF, PCNL does not have any advantage of shorter hospital stay than in open surgery as in the case with normal renal function. Obviously the postoperative pain and scar are disadvantages of open surgery that cannot be overlooked but in the scenario of a developing country, most of the patients are forced to compromise provided they can be made stone free at significantly lower cost of treatment. We have been removing renal stones percutaneously since 1988 and almost 1700 cases have been treated so far. So there is substantial experience in PCNL. Low clearance rate of PCNL in the setting of staghorn with CRF is not due to lack of experience, but in an attempt to minimize irrigation time and complication rate. In CRF we limit the number of punctures to 2-3 to reduce the risk of bleeding whereas in staghorn stones with normal renal function we have made up to 4-5 punctures to achieve complete stone clearance. We have treated over 130 complete staghom stones with normal renal function with a clearance rate of 85.5%. We agree that in the presence of renal failure, we have been less aggressive (during PCNL) in an effort to cut down the complication rate.
The result of this small prospective randomized study favors open surgery over PCNL in the management of staghorn stones with CRF in developing countries.
| Conclusion|| |
In view of the better clearance rate and lesser cost of treatment open surgery still has a place in the management of staghorn renal calculi with renal failure at a tertiary urological center in patients who are economically compromised. However postoperative pain and larger scar should be explained to the patient. These differences should be discussed with the patient beforehand and a collective decision regarding either of the modalities undertaken.
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[Figure - 1], [Figure - 2], [Figure - 3]
[Table - 1], [Table - 2], [Table - 3]