Urolithiasis DOI 10.1007/s00240-013-0624-1
ORIGINAL PAPER
Retroperitoneoscopic versus open mini-incision ureterolithotomy for upper- and mid-ureteric stones: a prospective randomized study Jai Prakash • Vishwajeet Singh • Manoj Kumar Manoj Kumar • Rahul Janak Sinha • Satyanarayan Sankhwar
•
Received: 10 July 2013 / Accepted: 6 November 2013 Ó Springer-Verlag Berlin Heidelberg 2013
Abstract To compare the retroperitoneoscopic ureterolithotomy (RPLU) versus open mini-incision ureterolithotomy (MIOU) for large and impacted proximal or midureteric stones in prospective randomized manner and to assess the outcome results. In a prospective randomized study between January 2009 and December 2012, 35 RPLU and 35 MIOU were included in the study. The indications for ureterolithotomy were as primary treatment of large and impacted stones more than 1.5 cm in the proximal and midureter and as salvage treatment of failed ureteroscopy (URS)/extracorporeal shock wave lithotripsy (SWL). The two groups were compared for visual pain score on the first and second postoperative day, analgesic requirement, stone removal in one attempt, operative time, blood loss, postoperative complications, hospital stays and the period of convalescence. The difference in the visual pain score and the tramadol requirement was significantly higher in MIOU group. The hospital stay (RPLU 2.86 ± 0.43, MIOU 5.71 ± 0.67, P B 0.001) and period of convalescence (RPLU 12.29 ± 4.06, MIOU 24.11 ± 5.55, P B 0.001) were also significantly higher in MIOU group. The complications were 11.4 % (P B 0.02) in RPLU versus 17.4 % in MIOU group. However, the stone removal in one attempt was similar in both groups. In condition of failed URS/ SWL, unavailability of the full endoscopic armamentarium and limitation of costs, RPLU and MIOU both are safe and J. Prakash (&) V. Singh M. Kumar R. J. Sinha S. Sankhwar Department of Urology, King George Medical University, Lucknow, India e-mail: [email protected] M. Kumar Department of Radiodiagnosis, King George Medical University, Lucknow, India
effective treatment options for large impacted upper- and mid-ureteric stones and RPLU has better tolerability, lesser hospital time and equal stone clearance rate. Keywords Retroperitoneal laparoscopic ureterolithotomy Mini-incision open ureterolithotomy Upper- and mid-ureteric stone
Introduction Until the early 1980s, the open surgery was considered the standard treatment for renal and ureteric stones requiring intervention. Technological developments in last decades have remarkably changed the approach of ureteric stones treatment. Advances in equipment and the design of shock wave lithotripters, both for extracorporeal shock wave lithotripsy (SWL) and intracorporeal shock wave lithotripsy, and improving skills with these modalities, have greatly diminished the role of open surgery in managing ureteric calculi [1]. Nowadays, ureteric stones are usually managed by minimally invasive techniques like SWL [2], percutaneous antegrade removal [3] and ureteroscopy (URS) [4]. Still a small number of patients with failure of less invasive modalities, the presence of medical/anatomical abnormalities, a concomitant open procedure, and the presence of large impacted calculi for which patients prefer to avoid multiple procedures have to undergo laparoscopic ureterolithotomy (LU) or open ureterolithotomy (OU) [1]. The distinct advantages of LU compared to OU are less pain, minimal analgesic requirement, short hospital stay, shorter convalescence and better cosmesis reported in previous non-randomized studies [5, 6]. In this minimal invasive era, there are very little studies which actually compare the LU and OU techniques in prospective
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randomized design and most of the previous laparoscopic studies are retrospective [7–9]. To the best of our knowledge, prospective randomized study comparing retroperitoneal laparoscopic ureterolithotomy (RPLU) and miniincision open ureterolithotomy (MIOU) has not been reported earlier. Herein we are reporting a prospective randomized comparison of patients who underwent RPLU and MIOU for upper- and mid-ureteric stones.
Material and methods Between January 2009 and December 2012, 70 patients of upper- and mid-ureteric stones ([1.5 cm) were included in the study. The institutional ethical approval was obtained and it was in accordance with the declaration of Helsinki. The procedure of RPLU/MIOU was indicated as primary treatment of impacted, large ([1.5 cm) upper- or mid-ureteric stones in 44 cases and as a salvage treatment in failed SWL/ureteroscopy in 17 and 9 cases, respectively. Patients with active urinary tract infection, previous operative (open or laparoscopic) history of ipsilateral ureter or the ipsilateral lumber and abdominal regions were excluded. Apart from clinical history and examination, complete hemogram, renal function test, liver function test, serum calcium, serum uric acid, urine culture and bacterial sensitivity, renal and bladder ultrasound (USG), coagulation profiles, X-ray kidney, ureter and bladder (X-ray KUB) were performed in all cases. An intravenous urogram (IVU) was performed if there was normal renal function. The chest X-ray P.A. view, electrocardiogram and pulmonary function test were performed to assess the fitness for anesthesia. Stone size was determined by plain X-ray KUB and impacted stones were defined as stones that stay in the same position for more than 1 month and that do not allow contrast past them in the IVU or moderate to severe hydronephrosis in USG. Initially, JJ stenting was attempted in all patients and successful patients were excluded from the study and managed by ureteroscopy. The percutaneous nephrostomy was performed in patients with infected hydroureteronephrosis and JJ stenting was failed. Informed and written consent was obtained prior to randomization and surgical intervention after explaining that primary treatment modality would be open or laparoscopic ureterolithotomy. The randomization was done by computer generated table on 1:1 basis. The group I consisted of the patients who underwent RPLU and group II consisted of patients who underwent MIOU.
was given just distal and anterior to the 12 rib in mid-clavicular line. The muscles were splitted to expose the dorsolumbar fascia. This fascia was incised to enter in retroperitoneal space. By the blunt finger dissection, peritoneum was pushed and swept anteriorly to create retroperitoneal space. The space was further developed by the technique of indigenous balloon dissection method. The balloon was inflated up to 400 ml by normal saline and kept inflated for 7 min. Following deflation, a 10 mm camera port was placed and CO2 pneumoretroperitoneum was created, the CO2 pressure was maintained at 15 mm Hg. Under vision a 5 mm and 12 mm ports were placed. On left side, the 5 mm closed port placement was done in anterior axillary line just above and in front of anterior superior iliac spine, and 12 mm port placed lateral to erector spine muscle in posterior axillary line. On right side, the 12 mm port was inserted in anterior axillary line and 5 mm port in posterior axillary line similar to as described for the left side. The dissection was started as blunt dissection to identify the ureter, stone bulge was recognized and ureterotomy over the stone was given. The stone extracted and delivered outside through 2 cm port site with little enlargement of port site. The ureter was stented antegradly with 6 Fr DJ stent and ureterotomy was closed by 4-0 polyglactin as interrupted suture. An 18 F soft silastic drain was inserted in retroperitoneum and ports were closed. MIOU Surgery was conducted with the patient either under regional anesthesia (spinal or epidural)/general anesthesia. The patient’s position on the table and the surgical approach were determined by the location of the stone on preoperative plain films. For the upper-ureteric stones, the patients were placed in the kidney position and for the mid-ureteric stones, they were placed in supine position with a sand bag placed in back to make the operative area oblique and tilted. 5–10 cm skin incision was used with a muscle-splitting approach, the peritoneum was mobilized anteriorly and the psoas muscle located. The ureter was identified and secured proximal to the stone to prevent dislocation. It was then opened longitudinally directly over the stone and the stone was removed. The ureter was stented with 6 Fr DJ stent and ureterotomy was sutured with 4/0 polyglactin. A 24 F drain was placed in the retroperitoneal space. Polydioxanone suture was used to close the muscle layers and a 2/0 polypropylene sub-cuticular suture was used to close the skin.
RPLU
Postoperative course and care
After general anesthesia, the patients were placed in lateral decubitus (kidney position) with bridge at the flank. The open port placement (for camera) and the creation of potential retroperitoneal space were done first. A 2 cm open incision
The patient kept on intravenous fluid till the recovery of bowel sounds. Intravenous broad spectrum antibiotic (ceftriaxone) and tramadol on patient demand were administered. Visual pain analog scoring was done on first and second
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postoperative days. An X-ray KUB was done to check the position of DJ stent and stone clearance. The drainage tubes were removed if output was\30 ml in 24 h. The patients were discharged following Foley catheter and drainage tube removal. The JJ stent was removed after 4 weeks of operation under IV sedation and antibiotic cover. An intravenous urogram was performed at 3 months of follow-up. Subsequently, follow-up of the patients was at 6 months and then annually. In each visit apart from the history and clinical examination, serum creatinine, renal and bladder USG and X-ray KUB were done. An IVU was indicated if there was increasing hydroureteronephrosis or the patients were symptomatic. Statistical analysis Statistical analysis was performed using SPSS version 16.0. The data analysis was done using Mann–Whitney U test and Chi square test. Where appropriate p value of \0.05 was considered statistically significant.
Results The demographic characteristics of the patients are shown in Table 1. Both groups are comparable with respect of age, sex, mean stone size, stone location, mean serum
Table 1 The demographic characteristics of RPLU and MIOU groups
S. no.
creatinine and preoperative renal failure (Table 1). The mean incision length was 7 (5–10) cm in MIOU group. The Operative time was significantly higher in RPLU group (Table 2). The visual pain analog score on first and second postoperative days and requirement of tramadol were significantly higher in MIOU group (Table 2). The hospital stay and period of convalescence were significantly higher in MIOU group (Table 2). The overall complications in RPLU group were 11.4 % versus 17.2 % in MIOU group and this difference was significantly higher (Table 3). The complications were recorded and graded according to the modified clavien grading system [10]. In MIOU group, one patient developed incisional hernia at scar site and one patient developed chronic neurogenic pain possibly due to nerve entrapment in scar. Hernioplasty and nerve blockade were done for the management of the above complications. One patient in MIOU group developed stricture at operated site, managed by retrograde ureteropyelogram, balloon dilatation and stenting for 3 months. Success rate was 100 % in MIOU and 94.3 % in RPLU group. In two patients of RPLU, conversion to open was required because of stone migration into kidney in one patient and extensive periureteral fibrosis in another patient. The mean follow-up was 14.35 versus 14.89 months, respectively, in RPLU & MIOU group.
Parameters
MIOU (n = 35)
P value
1
Mean age in years
42.23 ± 5.56
41.45 ± 5.48
0.59
2
Sex ratio (male: female)
26:09
20:15
0.13
3
Laterality (right: left)
19:16
18:17
0.18
4
Mean weight in kg
56.82 ± 6.38
59.06 ± 5.33
0.67
5
Mean serum creatinine (mg/dl)
1.84 ± 1.11
1.99 ± 1.33
0.15
6
Renal failure (serum creatinine [ 1.5 mg %)
10
12
0.79
7
Location in ureter 20 15
18 17
0.76 0.76
Upper Middle
PCN percutaneous nephrostomy, ASA American Society of Anesthesiologists score, DTPA diethylene triamine penta-acetic acid
RPLU (n = 35)
8
Mean size of stone in mm
20 ± 3.2
21 ± 3.6
0.50
9
Preoperative PCN
6
7
0.73
10
Co-morbidities Diabetes mellitus
6
5
0.74
Hypertension
4
4
0.64
11
History of ESWL
8
9
0.71
12
History of attempted ureteroscopy
5
4
0.76
13
ASA score ASA 1
20
22
0.76
ASA 2
15
13
0.75
14
DTPA scan
7
8
0.71
15
IVU
25
23
0.78
16
Contralateral associated urolithiasis
10
12
0.82
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Urolithiasis Table 2 The operative and postoperative parameters
S. no.
Parameters
RPLU (n = 35) Mean ± SD
MIOU (n = 35) Mean ± SD
p value
\0.001
1
Operative time in min
83.80 ± 8.49
66.83 ± 8.81
2
Blood loss in ml
57.14 ± 11.32
59.14 ± 15.22
3
Visual pain score (VAS) on postoperative day 1
3.40 ± 0.74
6.40 ± 0.55
\0.001 \0.001
0.17
4
Visual pain score (VAS) on postoperative day 2
1.62 ± 0.49
4.57 ± 0.56
5
Tramadol requirement in mg on postoperative day 1
152.85 ± 49.91
265.71 ± 37.91 \0.001
6
Tramadol requirement in mg on postoperative day 2
109.52 ± 35.32
184.28 ± 39.80 \0.001
7 8
Hospital stay in days Convalescence in days
2.86 ± 0.43 12.29 ± 4.06
5.71 ± 0.67 24.11 ± 5.55
9
Follow-up in months
14.35
14.89
0.70
\0.001 \0.001
Table 3 Postoperative modified clavien complications in RPLU and MIOU groups Grade of complication
RPLU (n = 35)
Number of patients (%)
MIOU (n = 35)
Number of patients (%)
p value
Clavien grade I
Transient hematuria
1 (2.85 %)
Transient hematuria
–
NS
Clavien grade II
Fever (UTI) Excessive urine drainage
1 (2.85 %) 1 (2.85 %)
Fever (UTI) Excessive urine drainage
1 (2.85 %) 2 (5.71 %)
NS
Port site infection
1 (2.85 %)
–
–
–
Stricture at operated site
–
Stricture at operated site
1 (2.85 %)
Entrapment neuropathy
–
Clavien grade IIIb
Incisional hernia
1 (2.85 %)
Entrapment neuropathy
1 (2.85 %)
NS
UTI urinary tract infection
Discussion The management of ureteric stones has developed in recent decades and in modern endourological era the laparoscopic and open ureterolithotomy are not the primary treatment modalities. Minimally invasive procedures like SWL and URS have become the first line treatment for the ureteral calculi requiring surgical intervention [11]. SWL is suitable for managing ureteric stones of \1 cm [12], but as the stone size increases the chances of clearance decrease and requirement of multiple sessions increases. Impacted stones are associated with chronic inflammatory reactions and do not have enough space to expand, which limit the efficacy and stone clearance rate of SWL [13–16]. Endourological treatments have the advantages of avoiding the opening of urinary tract and possible urine extravasations and stricture. URS is best suited for stones in lowerand mid-ureter [17], but in impacted stones have low success rate and require multiple sessions [14]. Holmium: YAG lithotripsy combined with the flexible ureteroscope has reported stone-free rates of [97 % in all parts of the ureter [18]. Failure of endourological treatment is rare in modern endourological era [19] and should be considered as the initial treatment of choice for all ureteric stones requiring surgical intervention. But still there are some
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situations where ureteroscopy may unsuccessful, like hard impacted stones with mucosal edema where iatrogenic perforation may happen during laser lithotripsy, difficult ureteric access in condition of stricture formation, severe intravesical inflammation or extensive carcinoma in situ, previous ureteric re-implantation and severe kink of distal ureter [19, 20]. During the study period, JJ stenting was unsuccessful in large number of patients. We encountered 78 patients of primary large impacted upper- and mid-ureteric stones and 31 patients of failed SWL. Initially, JJ stenting was attempted in all these patients, but was unsuccessful in 44 of the 78 (56.41 %) primary patients and 17 of the 31 (54.83 %) failed SWL patients. Nine patients had history of attempted, but failed ureteroscopy. In four male patients stone location was too high to introduce the semirigid ureteroscope (Richard Wolf, 8/9.8 F and 430 mm working length). Two patients with history of previous hysterectomy had difficult ureter (severe kink) so scope could not be reached up to stone and three patients had severe bladder trabeculations with mucosal edema with bladder diverticulations where ureteric orifice could not be localized. Higher cost and maintenance of the finer flexible ureteroscopes also limit the availability of this procedure
Urolithiasis
particularly in developing countries [21]. For the large proximal ureteral stones standard treatment options are still a point of controversy [11–13]. Recently, it has been demonstrated that success rate for ureteric stone removal is directly related to invasiveness of the procedure [22]. Antegrade removal is also an option for large impacted proximal stones, but it is an invasive procedure which requires puncture and dilatation. Puncture and dilatation is the major cause of postoperative pain and also there is rare but serious risk of early brisk and delayed hemorrhage [23, 24]. The puncture and dilatation is omitted in laparoscopy and risk of hemorrhage is negligible hence laparoscopic ureterolithotomy is less invasive procedure. All ureteral stones cannot be managed successfully with minimal invasive procedures and antegrade approach, so laparoscopic or open ureterolithotomy is feasible alternatives in the treatment of these cases. Initially, Wickham [25] described laparoscopic ureterolithotomy in 1979 and this has now established to be a minimally invasive alternative to open surgery. After Gaur described retroperitoneal laparoscopic surgery facilitated by a hydraulic balloon dilatation system in 1992 [26], straightforward access became available through the retroperitoneum. RPLU has advantages over transperitoneal access by obviating compromise of the peritoneum and mobilizing the viscera, and by preventing urine spillage into the peritoneal cavity. However, the retroperitoneal approach offers a limited working place and it is often difficult to find the ureter due to lack of anatomical landmarks [27]. The current indications of open ureterolithotomy are very limited in well-equipped endourological centers and the major indications are high risk patients, precluding multiple general or major regional anesthesias, failure of minimal invasive methods, large impacted calculus, patient preference and institutional resident training program [1, 28, 29]. Regarding the LU and OU, most of the previous studies are retrospective and actual comparative and prospective randomized studies are very limited in the existing literature in this minimal invasive era [7–9]. Our institution is a major referral center for stone disease (situated in stone belt of India and caters 220 million populations) and we frequently encounter patients with large and complex stones or referred cases of SWL or URS failure. Among the different treatment modalities available at our institute, proper selection of these patients is critical in obtaining complete stone clearance in a single sitting with minimum morbidity to the patient. Because of limited endoscopic armamentarium to cope with the large patient burden, to get stone clearance in one attempt and thereby decrease the overall cost and complications (limitation of cost), by patient preference and as an institutional resident training program, we frequently perform open or
laparoscopic ureterolithotomy in these patients and got the large accrual of patients for the present study. However, endourological treatment could have been given priority, but laparoscopic or open approach is also justified in large (1.5 cm) and impacted stones because the removal of the entire stone bulk in one sitting is very cost effective and has been reported especially in the context of developing countries [30, 31]. Recently, we have been reported laparoscopic ureterolithotomy as an indication for the primary treatment of large and impacted upper- and mid-ureteric stones [32]. The mean operative duration was significantly higher in RPLU group. This could be explained by the limited working space available in RPLU. This operative time in RPLU is higher than that observed by Hemal et al. [33] who had a mean operative time of 67 (40–97) minutes. Skrepetis compared open versus transperitoneal laparoscopic ureterolithotomy (TPLU) in 36 patients and concluded that the operation time was significantly longer in the laparoscopic group [34]. In our study mean blood loss was not significant in either group with 57 ml in open group and 59 ml in retroperitoneoscopic group. In previous study by Hemal et al. [6], blood losses during open and retroperitoneoscopic ureterolithotomy were similar. Recently, our prospective randomized study comparing RPLU and TPLU showed similar blood loss in both groups [32]. There was significant difference between the mean visual pain score between two groups with mean score in RPLU and in MIOU group being 3.40 and 6.40 on day 1 and 1.62 and 4.57 on day 2, respectively, as laparoscopic technique involves less muscle cutting and splitting leading to minimization of incisional pain. Total analgesic requirement (tramadol in mg) was less in RPLU than in MIOU group because of better tolerability of RPLU than MIOU. However, compared to several series that reported open conversion rates of up to 10 % [7, 35, 36], our series resulted in lesser conversion rate (5.6 %). In two patients of RPLU conversion to open was required, in one patient the stone was migrated into kidney and in another patient there was extensive peri-ureteral fibrosis. Hemal et al. [9] reported the lowest success rate (75 %) in their RPLU series, and explained that open conversion happened early in their series and that it was related to the learning curve. Peri-operative complications like wound infection, fever and persistent urine leakage were similar in both groups. Prolonged urine leaks ([72 h) were present in two patients in MIOU group and in one patient in the RPLU group, who were managed conservatively. The decision of whether or not to suture the ureterotomy and place a stent in the ureter is controversial. El-Moula et al. [37] documented a multicentre retrospective study of 64 laparoscopic retroperitoneal procedures which left the
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ureter open with a double-J, with only one patient suffering a prolonged loss of urine. The intracorporeal suturing of ureterotomy and routine internal stenting have reduced complications such as urinary leak and prolonged hospital stay. In a study on TPLU for upper-ureteral stones in 10 patients Nualyong and Taweemonkongsap [38] did not perform ureterotomy suturing and internal stenting and showed that urinary leak remains the cause of a longer hospital stay. They concluded that intracorporeal ureterotomy closure decreases postoperative urine leak and hospital stay. In our study, stents were inserted routinely because the stones were large and impacted, and ureteral mucosa was ulcerated in the majority of cases. It was our assumption that ureteral stent insertion prevents the formation of ureteral stricture. Roberts et al. [39] reported an incidence of 24 % for ureteric stricture in patients with impacted ureteric stones. We noted ureteric stricture at operated site in one patient in MIOU group. This patient had impacted calculus and severe peri-ureteric fibrosis seen intraoperatively and was managed by retrograde balloon dilatation and prolonged stenting. In the present study, mean hospital stay was 2.86 ± 0.43 days in RPLU group and 5.71 ± 0.67 days in MIOU group. Patients in RPLU group returned to their normal activities earlier. Our hospital stay in RPLU group patients is comparable with the previous studies on laparoscopic ureterolithotomy [40–42]. At our center we are performing retroperitoneoscopy frequently for ureteric stones, PUJ obstruction and small renal tumors. According to our experience in a single institution, RPLU is technically difficult and requires more surgical skills because of limited working space but offers significant advantages of improved analgesia and reduced periods of hospital stay. It is our strong belief that one should versatile with endourological and laparoscopic skills for comprehensive and precise management of ureteral stones. This study has some limitations like, patients in RPLU group were light weighted and this could facilitate retroperitoneal access, but there was no selection bias and the study population was just by chance.
Conclusion In condition of failed SWL/endourological procedures, unavailability of the full endoscopic armamentarium and limitation of costs, both RPLU and MIOU are safe and effective treatment options for large impacted upper- and mid-ureteric stones and RPLU should be preferred over open ureterolithotomy because RPLU has the definite advantage of reduced invasiveness, i.e., better tolerability, lesser hospital time and equal stone clearance rate.
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Conflict of interest
None.
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40.
41. 42.
comparison to rigid ureteroscopic pneumatic lithotripsy. J Laparoendosc Adv Surg Tech A 21:7–13 Farooq Qadri SJ, Khan N, Khan M (2011) Retroperitoneal laparoscopic ureterolithotomy—a single centre 10 year experience. Int J Surg 9:160–164 Singh V, Sinha RJ, Gupta DK, Kumar M, Akhtar A (2013) Transperitoneal versus retroperitoneal laparoscopies ureterolithotomy: a prospective randomized comparison study. J Urol 189:940–945 Hemal AK, Goel A, Goel R (2003) Minimally Invasive Retroperitoneoscopic Ureterolithotomy. J Urol 169:480–482 Skrepetis K, Doumas K, Siafakas I, Lykourinas M (2001) Laparoscopic versus open ureterolithotomy. A comparative study. Eur Urol 40:32–36 Harewood LM, Webb DR, Pope AJ (1994) Laparoscopic ureterolithotomy: the results of an initial series, and an evaluation of its role in the management of ureteric calculi. Br J Urol 74:170–176 Keeley FX, Gialas I, Pillai M, Chrisofos M, Tolley DA (1999) Laparoscopic ureterolithotomy: the Edinburgh experience. BJU Int 84:765–769 El-Moula MG, Abdallah A, El-Anany F, Abdelsalam Y, Abolyosr A, Abdelhameed D, Izaki H, Elhaggagy A, Kanayama HO (2008) Laparoscopic ureterolithotomy: our experience with 74 cases. Int J Urol 15:593–597 Nualyong C, Taweemonkongsap T (1999) Laparoscopic ureterolithotomy for upper ureteric calculi. J Med Assoc Thai 82:1028 Roberts WW, Cadeddu JA, Micali S, Kavoussi LR, Moore RG (1998) Ureteral stricture formation after removal of impacted calculi. J Urol 159:723–726 Feyaerts A, Rietbergen J, Navarra S, Vallancien G, Guillonneau B (2001) Laparoscopic ureterolithotomy for ureteral calculi. Eur Urol 40:609–613 El-Feel A, Abouel-Fetouh H, Abdel-Hakim AM (2007) Laparoscopic transperitoneal ureterolithotomy. J Endourol 21:50–54 Basiri A, Simforoosh N, Ziaee A, Shayaninasab H, Moghaddam SM, Zare S (2008) Retrograde, antegrade, and laparoscopic approaches for the management of large, proximal ureteral stones: a randomized clinical trial. J Endourol 22:2677–2680
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ORIGINAL PAPER
Retroperitoneoscopic versus open mini-incision ureterolithotomy for upper- and mid-ureteric stones: a prospective randomized study Jai Prakash • Vishwajeet Singh • Manoj Kumar Manoj Kumar • Rahul Janak Sinha • Satyanarayan Sankhwar
•
Received: 10 July 2013 / Accepted: 6 November 2013 Ó Springer-Verlag Berlin Heidelberg 2013
Abstract To compare the retroperitoneoscopic ureterolithotomy (RPLU) versus open mini-incision ureterolithotomy (MIOU) for large and impacted proximal or midureteric stones in prospective randomized manner and to assess the outcome results. In a prospective randomized study between January 2009 and December 2012, 35 RPLU and 35 MIOU were included in the study. The indications for ureterolithotomy were as primary treatment of large and impacted stones more than 1.5 cm in the proximal and midureter and as salvage treatment of failed ureteroscopy (URS)/extracorporeal shock wave lithotripsy (SWL). The two groups were compared for visual pain score on the first and second postoperative day, analgesic requirement, stone removal in one attempt, operative time, blood loss, postoperative complications, hospital stays and the period of convalescence. The difference in the visual pain score and the tramadol requirement was significantly higher in MIOU group. The hospital stay (RPLU 2.86 ± 0.43, MIOU 5.71 ± 0.67, P B 0.001) and period of convalescence (RPLU 12.29 ± 4.06, MIOU 24.11 ± 5.55, P B 0.001) were also significantly higher in MIOU group. The complications were 11.4 % (P B 0.02) in RPLU versus 17.4 % in MIOU group. However, the stone removal in one attempt was similar in both groups. In condition of failed URS/ SWL, unavailability of the full endoscopic armamentarium and limitation of costs, RPLU and MIOU both are safe and J. Prakash (&) V. Singh M. Kumar R. J. Sinha S. Sankhwar Department of Urology, King George Medical University, Lucknow, India e-mail: [email protected] M. Kumar Department of Radiodiagnosis, King George Medical University, Lucknow, India
effective treatment options for large impacted upper- and mid-ureteric stones and RPLU has better tolerability, lesser hospital time and equal stone clearance rate. Keywords Retroperitoneal laparoscopic ureterolithotomy Mini-incision open ureterolithotomy Upper- and mid-ureteric stone
Introduction Until the early 1980s, the open surgery was considered the standard treatment for renal and ureteric stones requiring intervention. Technological developments in last decades have remarkably changed the approach of ureteric stones treatment. Advances in equipment and the design of shock wave lithotripters, both for extracorporeal shock wave lithotripsy (SWL) and intracorporeal shock wave lithotripsy, and improving skills with these modalities, have greatly diminished the role of open surgery in managing ureteric calculi [1]. Nowadays, ureteric stones are usually managed by minimally invasive techniques like SWL [2], percutaneous antegrade removal [3] and ureteroscopy (URS) [4]. Still a small number of patients with failure of less invasive modalities, the presence of medical/anatomical abnormalities, a concomitant open procedure, and the presence of large impacted calculi for which patients prefer to avoid multiple procedures have to undergo laparoscopic ureterolithotomy (LU) or open ureterolithotomy (OU) [1]. The distinct advantages of LU compared to OU are less pain, minimal analgesic requirement, short hospital stay, shorter convalescence and better cosmesis reported in previous non-randomized studies [5, 6]. In this minimal invasive era, there are very little studies which actually compare the LU and OU techniques in prospective
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randomized design and most of the previous laparoscopic studies are retrospective [7–9]. To the best of our knowledge, prospective randomized study comparing retroperitoneal laparoscopic ureterolithotomy (RPLU) and miniincision open ureterolithotomy (MIOU) has not been reported earlier. Herein we are reporting a prospective randomized comparison of patients who underwent RPLU and MIOU for upper- and mid-ureteric stones.
Material and methods Between January 2009 and December 2012, 70 patients of upper- and mid-ureteric stones ([1.5 cm) were included in the study. The institutional ethical approval was obtained and it was in accordance with the declaration of Helsinki. The procedure of RPLU/MIOU was indicated as primary treatment of impacted, large ([1.5 cm) upper- or mid-ureteric stones in 44 cases and as a salvage treatment in failed SWL/ureteroscopy in 17 and 9 cases, respectively. Patients with active urinary tract infection, previous operative (open or laparoscopic) history of ipsilateral ureter or the ipsilateral lumber and abdominal regions were excluded. Apart from clinical history and examination, complete hemogram, renal function test, liver function test, serum calcium, serum uric acid, urine culture and bacterial sensitivity, renal and bladder ultrasound (USG), coagulation profiles, X-ray kidney, ureter and bladder (X-ray KUB) were performed in all cases. An intravenous urogram (IVU) was performed if there was normal renal function. The chest X-ray P.A. view, electrocardiogram and pulmonary function test were performed to assess the fitness for anesthesia. Stone size was determined by plain X-ray KUB and impacted stones were defined as stones that stay in the same position for more than 1 month and that do not allow contrast past them in the IVU or moderate to severe hydronephrosis in USG. Initially, JJ stenting was attempted in all patients and successful patients were excluded from the study and managed by ureteroscopy. The percutaneous nephrostomy was performed in patients with infected hydroureteronephrosis and JJ stenting was failed. Informed and written consent was obtained prior to randomization and surgical intervention after explaining that primary treatment modality would be open or laparoscopic ureterolithotomy. The randomization was done by computer generated table on 1:1 basis. The group I consisted of the patients who underwent RPLU and group II consisted of patients who underwent MIOU.
was given just distal and anterior to the 12 rib in mid-clavicular line. The muscles were splitted to expose the dorsolumbar fascia. This fascia was incised to enter in retroperitoneal space. By the blunt finger dissection, peritoneum was pushed and swept anteriorly to create retroperitoneal space. The space was further developed by the technique of indigenous balloon dissection method. The balloon was inflated up to 400 ml by normal saline and kept inflated for 7 min. Following deflation, a 10 mm camera port was placed and CO2 pneumoretroperitoneum was created, the CO2 pressure was maintained at 15 mm Hg. Under vision a 5 mm and 12 mm ports were placed. On left side, the 5 mm closed port placement was done in anterior axillary line just above and in front of anterior superior iliac spine, and 12 mm port placed lateral to erector spine muscle in posterior axillary line. On right side, the 12 mm port was inserted in anterior axillary line and 5 mm port in posterior axillary line similar to as described for the left side. The dissection was started as blunt dissection to identify the ureter, stone bulge was recognized and ureterotomy over the stone was given. The stone extracted and delivered outside through 2 cm port site with little enlargement of port site. The ureter was stented antegradly with 6 Fr DJ stent and ureterotomy was closed by 4-0 polyglactin as interrupted suture. An 18 F soft silastic drain was inserted in retroperitoneum and ports were closed. MIOU Surgery was conducted with the patient either under regional anesthesia (spinal or epidural)/general anesthesia. The patient’s position on the table and the surgical approach were determined by the location of the stone on preoperative plain films. For the upper-ureteric stones, the patients were placed in the kidney position and for the mid-ureteric stones, they were placed in supine position with a sand bag placed in back to make the operative area oblique and tilted. 5–10 cm skin incision was used with a muscle-splitting approach, the peritoneum was mobilized anteriorly and the psoas muscle located. The ureter was identified and secured proximal to the stone to prevent dislocation. It was then opened longitudinally directly over the stone and the stone was removed. The ureter was stented with 6 Fr DJ stent and ureterotomy was sutured with 4/0 polyglactin. A 24 F drain was placed in the retroperitoneal space. Polydioxanone suture was used to close the muscle layers and a 2/0 polypropylene sub-cuticular suture was used to close the skin.
RPLU
Postoperative course and care
After general anesthesia, the patients were placed in lateral decubitus (kidney position) with bridge at the flank. The open port placement (for camera) and the creation of potential retroperitoneal space were done first. A 2 cm open incision
The patient kept on intravenous fluid till the recovery of bowel sounds. Intravenous broad spectrum antibiotic (ceftriaxone) and tramadol on patient demand were administered. Visual pain analog scoring was done on first and second
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postoperative days. An X-ray KUB was done to check the position of DJ stent and stone clearance. The drainage tubes were removed if output was\30 ml in 24 h. The patients were discharged following Foley catheter and drainage tube removal. The JJ stent was removed after 4 weeks of operation under IV sedation and antibiotic cover. An intravenous urogram was performed at 3 months of follow-up. Subsequently, follow-up of the patients was at 6 months and then annually. In each visit apart from the history and clinical examination, serum creatinine, renal and bladder USG and X-ray KUB were done. An IVU was indicated if there was increasing hydroureteronephrosis or the patients were symptomatic. Statistical analysis Statistical analysis was performed using SPSS version 16.0. The data analysis was done using Mann–Whitney U test and Chi square test. Where appropriate p value of \0.05 was considered statistically significant.
Results The demographic characteristics of the patients are shown in Table 1. Both groups are comparable with respect of age, sex, mean stone size, stone location, mean serum
Table 1 The demographic characteristics of RPLU and MIOU groups
S. no.
creatinine and preoperative renal failure (Table 1). The mean incision length was 7 (5–10) cm in MIOU group. The Operative time was significantly higher in RPLU group (Table 2). The visual pain analog score on first and second postoperative days and requirement of tramadol were significantly higher in MIOU group (Table 2). The hospital stay and period of convalescence were significantly higher in MIOU group (Table 2). The overall complications in RPLU group were 11.4 % versus 17.2 % in MIOU group and this difference was significantly higher (Table 3). The complications were recorded and graded according to the modified clavien grading system [10]. In MIOU group, one patient developed incisional hernia at scar site and one patient developed chronic neurogenic pain possibly due to nerve entrapment in scar. Hernioplasty and nerve blockade were done for the management of the above complications. One patient in MIOU group developed stricture at operated site, managed by retrograde ureteropyelogram, balloon dilatation and stenting for 3 months. Success rate was 100 % in MIOU and 94.3 % in RPLU group. In two patients of RPLU, conversion to open was required because of stone migration into kidney in one patient and extensive periureteral fibrosis in another patient. The mean follow-up was 14.35 versus 14.89 months, respectively, in RPLU & MIOU group.
Parameters
MIOU (n = 35)
P value
1
Mean age in years
42.23 ± 5.56
41.45 ± 5.48
0.59
2
Sex ratio (male: female)
26:09
20:15
0.13
3
Laterality (right: left)
19:16
18:17
0.18
4
Mean weight in kg
56.82 ± 6.38
59.06 ± 5.33
0.67
5
Mean serum creatinine (mg/dl)
1.84 ± 1.11
1.99 ± 1.33
0.15
6
Renal failure (serum creatinine [ 1.5 mg %)
10
12
0.79
7
Location in ureter 20 15
18 17
0.76 0.76
Upper Middle
PCN percutaneous nephrostomy, ASA American Society of Anesthesiologists score, DTPA diethylene triamine penta-acetic acid
RPLU (n = 35)
8
Mean size of stone in mm
20 ± 3.2
21 ± 3.6
0.50
9
Preoperative PCN
6
7
0.73
10
Co-morbidities Diabetes mellitus
6
5
0.74
Hypertension
4
4
0.64
11
History of ESWL
8
9
0.71
12
History of attempted ureteroscopy
5
4
0.76
13
ASA score ASA 1
20
22
0.76
ASA 2
15
13
0.75
14
DTPA scan
7
8
0.71
15
IVU
25
23
0.78
16
Contralateral associated urolithiasis
10
12
0.82
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Urolithiasis Table 2 The operative and postoperative parameters
S. no.
Parameters
RPLU (n = 35) Mean ± SD
MIOU (n = 35) Mean ± SD
p value
\0.001
1
Operative time in min
83.80 ± 8.49
66.83 ± 8.81
2
Blood loss in ml
57.14 ± 11.32
59.14 ± 15.22
3
Visual pain score (VAS) on postoperative day 1
3.40 ± 0.74
6.40 ± 0.55
\0.001 \0.001
0.17
4
Visual pain score (VAS) on postoperative day 2
1.62 ± 0.49
4.57 ± 0.56
5
Tramadol requirement in mg on postoperative day 1
152.85 ± 49.91
265.71 ± 37.91 \0.001
6
Tramadol requirement in mg on postoperative day 2
109.52 ± 35.32
184.28 ± 39.80 \0.001
7 8
Hospital stay in days Convalescence in days
2.86 ± 0.43 12.29 ± 4.06
5.71 ± 0.67 24.11 ± 5.55
9
Follow-up in months
14.35
14.89
0.70
\0.001 \0.001
Table 3 Postoperative modified clavien complications in RPLU and MIOU groups Grade of complication
RPLU (n = 35)
Number of patients (%)
MIOU (n = 35)
Number of patients (%)
p value
Clavien grade I
Transient hematuria
1 (2.85 %)
Transient hematuria
–
NS
Clavien grade II
Fever (UTI) Excessive urine drainage
1 (2.85 %) 1 (2.85 %)
Fever (UTI) Excessive urine drainage
1 (2.85 %) 2 (5.71 %)
NS
Port site infection
1 (2.85 %)
–
–
–
Stricture at operated site
–
Stricture at operated site
1 (2.85 %)
Entrapment neuropathy
–
Clavien grade IIIb
Incisional hernia
1 (2.85 %)
Entrapment neuropathy
1 (2.85 %)
NS
UTI urinary tract infection
Discussion The management of ureteric stones has developed in recent decades and in modern endourological era the laparoscopic and open ureterolithotomy are not the primary treatment modalities. Minimally invasive procedures like SWL and URS have become the first line treatment for the ureteral calculi requiring surgical intervention [11]. SWL is suitable for managing ureteric stones of \1 cm [12], but as the stone size increases the chances of clearance decrease and requirement of multiple sessions increases. Impacted stones are associated with chronic inflammatory reactions and do not have enough space to expand, which limit the efficacy and stone clearance rate of SWL [13–16]. Endourological treatments have the advantages of avoiding the opening of urinary tract and possible urine extravasations and stricture. URS is best suited for stones in lowerand mid-ureter [17], but in impacted stones have low success rate and require multiple sessions [14]. Holmium: YAG lithotripsy combined with the flexible ureteroscope has reported stone-free rates of [97 % in all parts of the ureter [18]. Failure of endourological treatment is rare in modern endourological era [19] and should be considered as the initial treatment of choice for all ureteric stones requiring surgical intervention. But still there are some
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situations where ureteroscopy may unsuccessful, like hard impacted stones with mucosal edema where iatrogenic perforation may happen during laser lithotripsy, difficult ureteric access in condition of stricture formation, severe intravesical inflammation or extensive carcinoma in situ, previous ureteric re-implantation and severe kink of distal ureter [19, 20]. During the study period, JJ stenting was unsuccessful in large number of patients. We encountered 78 patients of primary large impacted upper- and mid-ureteric stones and 31 patients of failed SWL. Initially, JJ stenting was attempted in all these patients, but was unsuccessful in 44 of the 78 (56.41 %) primary patients and 17 of the 31 (54.83 %) failed SWL patients. Nine patients had history of attempted, but failed ureteroscopy. In four male patients stone location was too high to introduce the semirigid ureteroscope (Richard Wolf, 8/9.8 F and 430 mm working length). Two patients with history of previous hysterectomy had difficult ureter (severe kink) so scope could not be reached up to stone and three patients had severe bladder trabeculations with mucosal edema with bladder diverticulations where ureteric orifice could not be localized. Higher cost and maintenance of the finer flexible ureteroscopes also limit the availability of this procedure
Urolithiasis
particularly in developing countries [21]. For the large proximal ureteral stones standard treatment options are still a point of controversy [11–13]. Recently, it has been demonstrated that success rate for ureteric stone removal is directly related to invasiveness of the procedure [22]. Antegrade removal is also an option for large impacted proximal stones, but it is an invasive procedure which requires puncture and dilatation. Puncture and dilatation is the major cause of postoperative pain and also there is rare but serious risk of early brisk and delayed hemorrhage [23, 24]. The puncture and dilatation is omitted in laparoscopy and risk of hemorrhage is negligible hence laparoscopic ureterolithotomy is less invasive procedure. All ureteral stones cannot be managed successfully with minimal invasive procedures and antegrade approach, so laparoscopic or open ureterolithotomy is feasible alternatives in the treatment of these cases. Initially, Wickham [25] described laparoscopic ureterolithotomy in 1979 and this has now established to be a minimally invasive alternative to open surgery. After Gaur described retroperitoneal laparoscopic surgery facilitated by a hydraulic balloon dilatation system in 1992 [26], straightforward access became available through the retroperitoneum. RPLU has advantages over transperitoneal access by obviating compromise of the peritoneum and mobilizing the viscera, and by preventing urine spillage into the peritoneal cavity. However, the retroperitoneal approach offers a limited working place and it is often difficult to find the ureter due to lack of anatomical landmarks [27]. The current indications of open ureterolithotomy are very limited in well-equipped endourological centers and the major indications are high risk patients, precluding multiple general or major regional anesthesias, failure of minimal invasive methods, large impacted calculus, patient preference and institutional resident training program [1, 28, 29]. Regarding the LU and OU, most of the previous studies are retrospective and actual comparative and prospective randomized studies are very limited in the existing literature in this minimal invasive era [7–9]. Our institution is a major referral center for stone disease (situated in stone belt of India and caters 220 million populations) and we frequently encounter patients with large and complex stones or referred cases of SWL or URS failure. Among the different treatment modalities available at our institute, proper selection of these patients is critical in obtaining complete stone clearance in a single sitting with minimum morbidity to the patient. Because of limited endoscopic armamentarium to cope with the large patient burden, to get stone clearance in one attempt and thereby decrease the overall cost and complications (limitation of cost), by patient preference and as an institutional resident training program, we frequently perform open or
laparoscopic ureterolithotomy in these patients and got the large accrual of patients for the present study. However, endourological treatment could have been given priority, but laparoscopic or open approach is also justified in large (1.5 cm) and impacted stones because the removal of the entire stone bulk in one sitting is very cost effective and has been reported especially in the context of developing countries [30, 31]. Recently, we have been reported laparoscopic ureterolithotomy as an indication for the primary treatment of large and impacted upper- and mid-ureteric stones [32]. The mean operative duration was significantly higher in RPLU group. This could be explained by the limited working space available in RPLU. This operative time in RPLU is higher than that observed by Hemal et al. [33] who had a mean operative time of 67 (40–97) minutes. Skrepetis compared open versus transperitoneal laparoscopic ureterolithotomy (TPLU) in 36 patients and concluded that the operation time was significantly longer in the laparoscopic group [34]. In our study mean blood loss was not significant in either group with 57 ml in open group and 59 ml in retroperitoneoscopic group. In previous study by Hemal et al. [6], blood losses during open and retroperitoneoscopic ureterolithotomy were similar. Recently, our prospective randomized study comparing RPLU and TPLU showed similar blood loss in both groups [32]. There was significant difference between the mean visual pain score between two groups with mean score in RPLU and in MIOU group being 3.40 and 6.40 on day 1 and 1.62 and 4.57 on day 2, respectively, as laparoscopic technique involves less muscle cutting and splitting leading to minimization of incisional pain. Total analgesic requirement (tramadol in mg) was less in RPLU than in MIOU group because of better tolerability of RPLU than MIOU. However, compared to several series that reported open conversion rates of up to 10 % [7, 35, 36], our series resulted in lesser conversion rate (5.6 %). In two patients of RPLU conversion to open was required, in one patient the stone was migrated into kidney and in another patient there was extensive peri-ureteral fibrosis. Hemal et al. [9] reported the lowest success rate (75 %) in their RPLU series, and explained that open conversion happened early in their series and that it was related to the learning curve. Peri-operative complications like wound infection, fever and persistent urine leakage were similar in both groups. Prolonged urine leaks ([72 h) were present in two patients in MIOU group and in one patient in the RPLU group, who were managed conservatively. The decision of whether or not to suture the ureterotomy and place a stent in the ureter is controversial. El-Moula et al. [37] documented a multicentre retrospective study of 64 laparoscopic retroperitoneal procedures which left the
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ureter open with a double-J, with only one patient suffering a prolonged loss of urine. The intracorporeal suturing of ureterotomy and routine internal stenting have reduced complications such as urinary leak and prolonged hospital stay. In a study on TPLU for upper-ureteral stones in 10 patients Nualyong and Taweemonkongsap [38] did not perform ureterotomy suturing and internal stenting and showed that urinary leak remains the cause of a longer hospital stay. They concluded that intracorporeal ureterotomy closure decreases postoperative urine leak and hospital stay. In our study, stents were inserted routinely because the stones were large and impacted, and ureteral mucosa was ulcerated in the majority of cases. It was our assumption that ureteral stent insertion prevents the formation of ureteral stricture. Roberts et al. [39] reported an incidence of 24 % for ureteric stricture in patients with impacted ureteric stones. We noted ureteric stricture at operated site in one patient in MIOU group. This patient had impacted calculus and severe peri-ureteric fibrosis seen intraoperatively and was managed by retrograde balloon dilatation and prolonged stenting. In the present study, mean hospital stay was 2.86 ± 0.43 days in RPLU group and 5.71 ± 0.67 days in MIOU group. Patients in RPLU group returned to their normal activities earlier. Our hospital stay in RPLU group patients is comparable with the previous studies on laparoscopic ureterolithotomy [40–42]. At our center we are performing retroperitoneoscopy frequently for ureteric stones, PUJ obstruction and small renal tumors. According to our experience in a single institution, RPLU is technically difficult and requires more surgical skills because of limited working space but offers significant advantages of improved analgesia and reduced periods of hospital stay. It is our strong belief that one should versatile with endourological and laparoscopic skills for comprehensive and precise management of ureteral stones. This study has some limitations like, patients in RPLU group were light weighted and this could facilitate retroperitoneal access, but there was no selection bias and the study population was just by chance.
Conclusion In condition of failed SWL/endourological procedures, unavailability of the full endoscopic armamentarium and limitation of costs, both RPLU and MIOU are safe and effective treatment options for large impacted upper- and mid-ureteric stones and RPLU should be preferred over open ureterolithotomy because RPLU has the definite advantage of reduced invasiveness, i.e., better tolerability, lesser hospital time and equal stone clearance rate.
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Conflict of interest
None.
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