Tubeless Percutaneous Nephrolithotomy With and Without a Hemostatic Product: A Prospective, Randomized Study

ABSTRACT

INTRODUCTION: Guidelines for the use of topical hemostatic products have not been established and their necessity for every case is not determined. The purpose of the present prospective, randomized study was to compare the outcomes of tubeless percutaneous nephrolithotomy (PNL) with and without a hemostatic agent.

METHODS: A total of 48 patients with lower calyceal, middle calyceal, or pelvic renal stones ≤ 3 cm were randomly divided into 2 equal groups. All patients received single-stage tubeless PNL through 1 access tract. Group 1 had no local hemostatic agent; group 2 had oxidized regenerated cellulose (Surgicel; Ethicon Inc, Somerville, NJ, USA). Plain kidney, ureter, bladder X-ray and renal ultrasound were performed at the first postoperative day to evaluate the stone-free rate and detect any perinephric hematoma. Postoperative urinary leakage and postoperative hemoglobin (Hb) were also measured. Patients had ultrasound to determine the amount of the perinephric collection before being discharged.

RESULTS: No postoperative urinary leakage through the percutaneous tract was detected in either group. The mean (standard deviation) postoperative reduction in Hb concentration was 1.13 g/dL (1.11) for patients in group 1 and 1 g/dL (0.76) for patients in group 2; the group difference was not significant (P = .20). Most patients had no postoperative perinephric collection; minimal collection of 1 cm x 0.5 cm was detected in 2 cases in group 1 and 3 cases in group 2 (P = .30). No patient in either group had perinephric hematoma. Most patients were stone free: 22 patients (91.7%) in group 1; 20 patients (83.3%) in group 2.

CONCLUSIONS: Topical hemostatic agents may not be needed after an uncomplicated percutaneous renal procedure.

KEYWORDS: Percutaneous nephrolithotomy; Tubeless PNL; Hemostatic agents.

CORRESPONDENCE: Mohamed H. Ali, MD, Lecturer of Urology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt ().

CITATION: Urotoday Int J. 2010 Aug;3(4). doi:10.3834/uij.1944-5784.2010.08.05

ABBREVIATIONS AND ACRONYMS: FDA, Food and Drug Administration; Hb, hemoglobin; KUB, kidney, ureter, bladder; PNL, percutaneous nephrolithotomy.

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INTRODUCTION

Percutaneous nephrolithotomy (PNL) has become an integral part of renal stone management since its first description in 1976 [1]. Traditionally, a wide-bore nephrostomy tube is placed in the pelvicaliceal system at the end of PNL. It provides an effective tamponade to an acute nephrostomy tract, ensures proper drainage of urine, and facilitates easy access if repeat PNL is required. Unfortunately, the nephrostomy tube is associated with significant postoperative discomfort and pain because it lies in the vicinity of the rib cage. To minimize discomfort, surgeons may elect not to place a tube after an uncomplicated procedure with complete stone clearance [2-6], choosing instead to use an external ureteral catheter for 2 days. This surgery is known as a tubeless PNL.

Topical hemostatic products have been found to be effective and safe for controlling surface bleeding during trauma related to urological procedures. They can be used to stop bleeding from the nephrostomy tract after tubeless PNL in select patients [7]. These products include: (1) oxidized regenerated cellulose (eg, Surgicel; Ethicon Inc, Somerville, NJ, USA), (2) fibrin sealant (eg, Tissel VH Kit, Baxter AG, Vienna, Austria; and Hemaseel APR, Haemacure Corp, Montreal, Canada), (3) gelatin matrix (eg, FloSeal; Baxter Healthcare Corp, Deerfield, IL, USA), and (4) polyethylene glycol (eg, CoSeal; Baxter Healthcare Corp, Deerfield, IL, USA).

Guidelines for the use of topical hemostatic products have not been established and their necessity for every case is not determined. The purpose of the present prospective, randomized study was to compare the outcomes of bleeding and urinary extravasation following tubeless PNL with and without the topical hemostatic product of oxidized regenerated cellulose (Surgicel).

METHODS

Participants

The participants were 48 patients with lower calyceal, middle calyceal, or pelvic renal stones. All patients had normal renal anatomy and stone burden ≤ 3 cm. The stone size and location were evaluated preoperatively by kidney, ureter, bladder (KUB) X-ray, renal ultrasound, and intravenous urography. Exclusion criteria for the study were: (1) intraoperative significant bleeding, which was defined as persistent bleeding that occurred throughout the case and was not alleviated by the tamponade effect of the nephrostomy sheath; (2) intraoperative renal pelvic perforation; (3) a significant residual stone(s) that needed a second PNL; or (4) severe hydronephrosis.

Table 1 contains the pretreatment demographic characteristics of the patients. The groups were similar in age, gender, side and size of stones, presenting symptoms (mainly loin pain), and associated comorbid conditions.

Procedures

The study was approved by the Committee of Research Ethics of the Faculty of Medicine, Suez Canal University. The patients provided written informed consent, with full disclosure of the nature of the study.

The participants were randomly divided into 2 groups. Patients in group 1 (n = 24) received no hemostatic agents; patients in group 2 (n = 24) received oxidized regenerated cellulose (Surgicel).

Preoperative hemoglobin (Hb), urine analysis, bleeding profile, and renal function tests were completed. All patients received a standard tubeless PNL. Single-stage percutaneous renal surgery was performed by a senior surgeon in conjunction with a resident, with the urologist performing the percutaneous access. Each renal unit received only 1 access tract.

All procedures were conducted with the patient under general anesthesia in the prone position. Retrograde ureteral catheterization was performed. Initial percutaneous access was obtained after retrograde contrast injection. The tract was dilated under fluoroscopic control using polytetrafluoroethylene dilators. An Amplatz sheath of 26Fr to 30Fr was placed, depending on the degree of dilatation of the selected calyx and the bulk of the stone to be retrieved. Stone disintegration was done using a pneumatic lithotripter (Swiss Lithoclast; Electro Medical System, Le Sentier, Switzerland).

After completion of the PNL procedure, a guidewire was left across the ureteropelvic junction down to the ureter. Patients in group 2 had a 2 inch x 2 inch piece of absorbable Surgicel fixed in the nephrostomy tract inside the renal parenchyma, outside the pelvicalyceal system.

The Amplatz sheath was removed once there was only a thin bloody streak coming from the tract. Finally, the guidewire was removed and adhesive plaster was applied firmly to the incision. An external ureteral stent was left in place for 2 days.

Postoperative Evaluation

Plain KUB X-ray and renal ultrasound were performed at the first postoperative day, to evaluate the stone-free rate and detect any perinephric hematoma. Postoperative urinary leakage and postoperative Hb were also measured. Patients had an ultrasonographic assessment to determine the amount of the perinephric collection before being discharged home.

Statistical Analysis

The data were analyzed using the Statistical Package for Social Sciences (SPSS), version 11 (Chicago, IL, USA). Group comparisons were conducted for the outcome measures of: (1) mean reduction in Hb concentration, evaluated by Fisher's exact test, and (2) number of patients with postoperative perinephric fluid collection, evaluated by a chi-square test. Comparisons were considered significantly different at P < .05.

RESULTS

No postoperative urinary leakage through the percutaneous tract was detected in either group. The mean (standard deviation) postoperative reduction in Hb concentration was 1.13 g/dL (1.11) for patients in group 1, and 1 g/dL (0.76) for patients in group 2; the group difference was not significant (P = .20). Table 2 contains the number of patients with postoperative perinephric collection in each group. The vast majority of patients (22 out of 24 patients in group 1; 21 out of 24 patients in group 2) had no collection. The remainder had minimal collection, defined as the rim of the perinephric fluid measuring nearly 1 cm x 0.5 cm. There were no significant group differences in postoperative perinephric collection (P = .30).

No patient in either group had perinephric hematoma. A total of 22 patients (91.7%) in group 1 were stone free, compared with 20 patients (83.3%) in group 2. Patients with residual stones > 4 mm (2 patients in group 1; 4 patients in group 2) received extracorporeal shock wave lithotripsy as an auxiliary procedure.

DISCUSSION

Hemostasis begins with damage to tissues. The first stage is the vascular phase, in which vasoconstriction decreases the amount of blood flow to the area. The damage to the vascular endothelium exposes collagen, which then causes platelet aggregation and adhesion. These platelets release various clotting factors that initiate the clotting cascade and clot formation. This is followed by a clot retraction phase and finally a clot destruction phase, in which plasminogen is converted to plasmin which then causes clot lysis [8].

A good hemostatic agent must be safe, efficacious, and easy to use. Gelfoam (Pfizer Inc; New York, NY, USA), Surgicel, and Avitene (Davol Inc; Warwick, RI, USA) are all in the form of collagen sponges. They can be stored at room temperature and are basically ready to use out of the box. On the other hand, fibrin sealants need to be kept in cold storage and thawed prior to usage. Gelfoam and Surgicel collagen sponges are relatively inexpensive at $10-$20 per individual piece, whereas Avitene and fibrin sealants are much more expensive. All of these agents are regulated through the Food and Drug Administration (FDA) as a class III medical device, which means that the manufacturers are obligated to report to the FDA when an adverse event happens [8].

Oxidized regenerated cellulose (Surgicel) is derived from alpha-cellulose that is actually plant-based. On microscopic view, Surgicel comes in knit form. It is relatively acidic and is thought to cause some small vessel contraction. Like Gelfoam, it works at the same point in the intrinsic pathway of clotting and causes contact activation. It is thought to be relatively bacteriostatic when compared with other hemostatic agents. It needs to be applied dry and is absorbed within 4 to 8 weeks. On postoperative imaging, Surgicel sometimes causes a ring-enhancing lesion that can be mistaken for an abscess cavity [8]. Oxidized regenerated cellulose maintains a solid form when initially placed in direct contact with urine. It then assumes a semisolid gelatinous state that is still present at 5 days [7].

In the present study, postoperative perinephric collection was assessed by renal ultrasound. There was no statistically significant difference in mean perinephric collection between the group receiving Surgicel and the group without it. These results were similar to those found by Aghamir et al in 2004 [9]. They compared the outcomes of 43 patients undergoing totally tubeless PNL with 43 patients undergoing conventional PNL and found that none of the patients demonstrated urinoma or perinephric collection on postoperative renal ultrasound scans.

No postoperative urinary leakage from the nephrostomy tract was detected in either group in the present study. In 2008, Shoma and Elshal [10] published a prospective, randomized trial comparing conventional PNL with tubeless PNL using 50 patients. The authors stated that postoperative urinary leakage did not occur in any patient receiving tubeless PNL. The similarity in results between the previous and present studies may be due similar inclusion criteria.

Use of Surgicel in the present study made no difference in the outcome of postoperative urinary leakage. Aghamir et al [11] also examined the effects of Surgicel in stopping postoperative bleeding and urinary leakage. In their study, 20 patients undergoing tubeless PNL were evenly divided into those receiving Surgicel and those receiving no hemostatic aid. Their results were comparable to those of the present study, in that the outcomes were similar across groups. In both studies, the patients had uncomplicated percutaneous renal procedures. Results should not be generalized to more complex cases.

CONCLUSIONS

There was no significant difference in postoperative bleeding or urinary extravasation from the nephrostomy tract for patients receiving topical hemostatic agent oxidized regenerated cellulose (Surgicel) when compared with patients receiving no hemostatic agent. Such agents may not be needed after an uncomplicated percutaneous renal procedure.

Conflict of Interest: none declared

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