Duplicated Ureters in Transplantation-A Single-center, Retrospective Study.

BACKGROUND: Kidney transplantation remains the best therapeutic option for chronic renal failure. The objective of the study was to evaluate the impact of ureteral duplication in donor kidneys on transplantation outcome. METHODS: In this study we performed a retrospective analysis of 75 patients who had undergone renal transplantation. The evaluated parameters included frequency of occurrence and risk of reoperation and graftectomy, mortality, as well as dependency of early and long-term graft function on pyelocaliceal system duplication. RESULTS: Ureteral duplication was associated with more frequent double J stent catheter implantation (P < .05). There was no relationship detected between ureteral duplication, number of operations performed, and risk of graftectomy (P > .05). Early graft function with 2 ureters was similar to that of grafts with a single pyelocaliceal system. The long-term results were also comparable. CONCLUSION: Ureteral duplication should not be considered a contraindication for renal transplantation.

Resolución endoscópica combinada de una estenosis yatrógena en una ureterosigmoidostomía / Combined endoscopic resolution of iatrogenic stricture in an ureterosigmoidostomy

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[Modified Toyoda Method for Complete Duplex Ureters in Tubeless Cutaneous Ureterostomy : Report of a Case].

A 65-year-old man underwent radical cystectomy and cutaneous ureterostomy for bladder cancer. Because the patient had left complete duplex ureters,we modified the Toyoda method to construct the tubeless cutaneous ureterostomy with a unilateral stomal creation. The adhesive portion of both ureteral walls in duplex ureters was simultaneously cut approximately 5 mm from the distal end longitudinally,and the common sheath of the cut portion of the ureters was cut approximately 5 mm longitudinally in order to separate the two ureters. This procedure was repeated to make a"fish-mouth"aperture. Two opened ureteral walls were formed into the upper and lower plates of the Toyoda method stoma,respectively. To our knowledge,this is the first report of a surgical procedure of the tubeless cutaneous ureterostomy in complete duplex ureters.

Urinalysis findings are not predictive of positive urine culture in patients with indwelling stents.

INTRODUCTION: Indwelling stents produce symptoms and urinalysis findings mimicking urinary tract infection (UTI). In this study, we investigated the correlation of urinalysis findings with urine culture in patients with indwelling ureteral stents. MATERIALS AND METHODS: All patients with ureteral stents who underwent stent removal in urology clinic from July 2013 to January 2015 and had urine culture available immediately prior to stent removal were included in this study. Urine culture results as well as age, gender, duration of indwelling stent, and reason for stent placement were collected. RESULTS: A total of 122 patients were included in this study. The two most common reasons for ureteral stent placement included urolithiasis (65.6%) and renal transplant (22.1%). Red blood cell (RBC), leukocytes and nitrite were positive in 92.9%, 70.2% and 17.9% of urine samples respectively. Only 17 patients (13.9%) had positive urine culture. Although renal transplant patients had significantly longer duration of stent retention, no statistically significant difference was noted in rate of positive urine culture compared to urolithiasis patients (p = 1.0). Among patients with positive urine culture, 62.5% had resistant bacteria to common antibiotic treatments and two patients had yeast in urine culture (12.5%). The duration of stent retention did not correlate with bacterial resistance. Multivariate analysis failed to show significant correlation of gender, reason for stent, stent duration, RBC and nitrite with positive urine culture. CONCLUSIONS: Positive findings on urinalysis in patients with indwelling ureteral stent have poor correlation to positive urine culture and therefore the use of urine culture to diagnose UTI is warranted.

Infectious complications associated with the use of temporary prostatic urethral stents in patients with benign prostatic hyperplasia.

INTRODUCTION: To examine the infectious outcomes after the insertion of the temporary prostatic urethral stent (TPUS) in benign prostatic hyperplasia (BPH) patients. MATERIAL AND METHODS: Between November 2007 and September 2012, ninety TPUS were used in 33 patients with BPH at our institution. All patients had negative urine cultures prior to the first stent insertion. TPUS were sent for cultures at time of removal or exchange. Stents were removed at the time of definite surgical intervention, at 4-6 weeks, or when patients elected another course of treatment. Colonization was defined as asymptomatic positive stent culture. Infection was defined as symptomatic positive stent culture requiring treatment. Infection and colonization rates are reported. Logistic regression was used to examine the predictors of infection at any point. Predictors examined were age, body mass index, history of prostate cancer, diabetes mellitus, hyperlipidemia, coronary artery disease, neurologic disorder, erectile dysfunction and the sequence of stent placement. RESULTS: The majority of the subjects, 72% (24/33) had 1-2 stents, 9.0% (3/33) had 3-4 stents, 6.0% (2/33) had 5-6 stents, and 12% (4/33) of patients had more than 6 stents. From the 69 available culture results, the symptomatic infection rate was 16% (11/69) (95% CI: 8.2%-26.7%). The colonization rate was 58% (40/69) (95% CI: 45.5%-69.7%). None of the predictors examined were identified as a predictor of infection. There was no colonization detected when stents were removed in the first 20 days. CONCLUSION: Infection rates with TPUS in BPH patients are acceptable and early removal may prevent colonization.

Contemporary Series of Robotic-Assisted Distal Ureteral Reconstruction Utilizing Side Docking Position

Purpose: The robot-assisted approach to distal ureteral reconstruction is increasingly utilized. Traditionally, the robot is docked between the legs in lithotomy position resulting in limited bladder access for stent placement. We examined the use of side docking of the daVinci robot® to perform distal ureteral reconstruction. Materials and Methods: A retrospective review of distal ureteral reconstruction (ureteral reimplantation and uretero-ureterostomy) executed robotically was performed at a single institution by a single surgeon. The daVinci robotic® Si surgical platform was positioned at the right side of the patient facing towards the head of the patient, i.e. side docking. Results: A total of 14 cases were identified from 2011–2013. Nine patients underwent ureteral reimplantation for ureteral injury, two for vesicoureteral reflux, one for ureteral stricture, and one for megaureter. One patient had an uretero-ureterostomy for a distal stricture. Three patients required a Boari flap due to extensive ureteral injury. Mean operative time was 286 minutes (189–364), mean estimated blood loss was 40cc (10–200), and mean length of stay was 2.3 days (1–4). Follow-up renal ultrasound was available for review in 10/14 patients and revealed no long-term complications in any patient. Mean follow-up was 20.7 months (0.1–59.3). Conclusion: Robot-assisted laparoscopic distal ureteral reconstruction is safe and effective. Side docking of the robot allows ready access to the perineum and acceptable placement of the robot to successfully complete ureteral repair.

Contemporary Series of Robotic-Assisted Distal Ureteral Reconstruction Utilizing Side Docking Position.

PURPOSE: The robot-assisted approach to distal ureteral reconstruction is increasingly utilized. Traditionally, the robot is docked between the legs in lithotomy position resulting in limited bladder access for stent placement. We examined the use of side docking of the daVinci robot® to perform distal ureteral reconstruction. MATERIALS AND METHODS: A retrospective review of distal ureteral reconstruction (ureteral reimplantation and uretero-ureterostomy) executed robotically was performed at a single institution by a single surgeon. The daVinci robotic® Si surgical platform was positioned at the right side of the patient facing towards the head of the patient, i.e. side docking. RESULTS: A total of 14 cases were identified from 2011-2013. Nine patients underwent ureteral reimplantation for ureteral injury, two for vesicoureteral reflux, one for ureteral stricture, and one for megaureter. One patient had an uretero-ureterostomy for a distal stricture. Three patients required a Boari flap due to extensive ureteral injury. Mean operative time was 286 minutes (189-364), mean estimated blood loss was 40cc (10-200), and mean length of stay was 2.3 days (1-4). Follow-up renal ultrasound was available for review in 10/14 patients and revealed no long-term complications in any patient. Mean follow-up was 20.7 months (0.1-59.3). CONCLUSION: Robot-assisted laparoscopic distal ureteral reconstruction is safe and effective. Side docking of the robot allows ready access to the perineum and acceptable placement of the robot to successfully complete ureteral repair.

Initial experiences of a novel self-retaining intracorporeal retractor device for urologic laparoendoscopic single-site surgery.

BACKGROUND AND PURPOSE: Laparoendoscopic single-site surgery (LESS) is a surgical option for a number of urologic operations, although it does carry technical limitations. One of the major obstacles in performing LESS is accomplishing optimal retraction of adjacent organs. The aim of this study was to investigate the feasibility of a novel self-retaining intracorporeal retractor device, the Internal Organ Retractor (IOR), and to describe our experience using this device in LESS. PATIENTS AND METHODS: A total of 23 patients who underwent LESS using IOR between December 2012 and July 2013 were identified. Among these patients, 11 nephrectomies, 9 adrenalectomies, 1 pyeloplasty, and 2 nephroureterectomies were performed. Perioperative outcomes including operative time, complications related to use of the IOR, and amount of time needed for the application and removal of the IOR were measured during each operation. RESULTS: Adequate retraction was accomplished in all surgical cases. The IOR helped to maintain a consistent operative field throughout the surgery. A median application time of a single IOR was 85.0 (range 44.5-187.5) seconds and removal time was 50.0 (20-400) seconds. The median number of IOR sets used was 2.0 (range 1-4), and the median total application and removal time in a single operation were 170.0 (45-750) seconds and 95.0 (20-400) seconds, respectively. There were no perioperative complications associated with use of the IOR. CONCLUSIONS: The IOR provided satisfactory retraction during LESS, and its application/removal was uncomplicated and needed a minimal amount of time. The IOR reduced the need for additional laparoscopic ports for retraction. We believe that the IOR is a useful retraction tool for LESS and possibly multiport laparoscopic surgeries.

Split ureteral stent after ureteroureterostomy.

Ipsilateral ureteroureterostomy is a well documented surgical approach to duplicated collecting systems associated with obstruction or Vesicoureteral reflux. Indwelling stents are employed in these procedures, to facilitate unobstructed flow across the anastomosis, to minimize anastomotic leak, and to assist in aligning the repair. Positioning of the ureteral stent is controversial. Some advocate placement of the stent to the recipient ureter across the suture line to prevent anastomotic stricture. Others prefer placing the stent along the donor ureter in order to facilitate drainage of the moiety that was originally obstructed. We describe a technique that allows drainage both ureters by using a single stent that has been split at its proximal end just across the U-U anastomosis.

Robot-assisted uretero-ureterostomy for iatrogenic lumbar and iliac ureteral stricture: technical details and preliminary clinical results.

BACKGROUND: Although the incidence of iatrogenic ureteral strictures is low, the treatment remains challenging. OBJECTIVE: To report our technique of robot-assisted uretero-ureterostomy (RAUU) for adults with iatrogenic lumbar and iliac stricture. DESIGN, SETTING, AND PARTICIPANTS: A descriptive study was performed by our department. Since April 2009, five patients underwent RAUU: Two patients had developed a lumbar or iliac ureteral stricture following a ureterorenoscopy, one had ureteral catheter positioning, one had colon surgery, and one had resection of retroperitoneal cystic lymphangioma. Preoperative evaluation includes history, computed tomography (CT) scan, and mercaptoacetyltriglycine-3 (MAG3) diuretic renal scan. SURGICAL PROCEDURE: A flank position was used for all patients with lumbar stenosis. A supine position with the bed turned 30° was required for iliac stricture. The optical port, two 8-mm robotic ports, and one 5-mm assistant port were used. A precise definition of the site and extension of the stricture was done using the flexible ureterorenoscope. After the stricture resection, the anastomosis was performed with two running sutures on a ureteral double-J stent. MEASUREMENTS: Success was defined as no postoperative symptoms and evidence of no obstruction at the CT/urography and at the MAG3 scan at 6-mo follow-up. RESULTS AND LIMITATIONS: RAUU was technically feasible in all five patients. Average operating time was 135min, and median hospital stay was 3 d. No significant complications occurred. Absence of stricture recurrence and no reduction of kidney function were confirmed by CT/urography and MAG3 scans. At a mean follow-up of 8 mo, all patients were asymptomatic. The main limitations were the short follow-up and the small sample size. CONCLUSIONS: RAUU is feasible and safe for repairing iatrogenic lumbar and iliac ureteral strictures. The flexible ureterorenoscopy is useful to localise the obstruction and to correctly define its site and extension to spare as much ureter as possible.

Experience with robot assisted laparoscopic surgery for upper and lower benign and malignant ureteral pathologies.

OBJECTIVES: To present our experience and outcomes of robot-assisted laparoscopic surgery (RALS) performed for different ureteral pathologies and to discuss the true utility of robotics in ureteral surgery. METHODS: We reviewed a total of 44 procedures performed for diverse ureteral pathologies involving the proximal and distal ureter in 2 institutions from July 2006 to July 2009. Operative time, blood loss, length of stay, complications, and subjective and objective follow-up were evaluated. RESULTS: The 44 cases included 18 distal ureteral procedures including 5 distal ureterectomy with ureteroneocystostomy; 1 ureteroneocystostomy with psoas hitch; 2 ureteroneocystostomy with vesicovaginal fistula repair; 9 megaureter repairs in 8 cases; there were 12 proximal ureteral procedures including 7 ureteroureterostomies and 4 retrocaval ureter repairs; 10 ablative procedures consisting of 5 nephroureterectomies with cuff of bladder and 5 nephroureterectomies and 4 miscellaneous procedures. The mean operative time was 137.9 minutes (range: 70-240). Mean blood loss was 98.2 mL (range: <50-400). There were no urine leaks. Mean drain tube duration was 1.4 days (range: 1-2.5) and mean hospital stay was 2.4 days (range: 1-6). Complications included 1 case of sepsis and 1 antibiotic-induced infection. Average follow-up period was 13.5 months. Operative success as defined by symptom resolution and imaging was 100%. CONCLUSIONS: RALS is feasible, safe, and an effective option for ureteral pathologies at any level of the ureter with minimal peri-operative morbidity. However, appropriate port placement, patient positioning, and versatile experience of team is critical in handling such cases for better outcomes.

Transuretero-ureterostomía espontánea después de estenosis completa de un conducto ileal, con cuatro años de seguimiento conservador / Spontaneous transuretero-ureterostomy after complete stenosis of an ileal conduit, with four years of conservative follow-up

Introducción: La estenosis del conducto ileal es una complicación infrecuente de esta derivación urinaria. En el caso que describimos pasó durante un tiempo inadvertida y llevó al paciente a una situación de riesgo. Después de implantar una nefrostomía bilateral, se encontró una transuretero-ureterostomia espontánea. Caso Clínico: Un varón de 70 años con un conducto ileal realizado 15 años antes por tener tumor vesical, ingresó con signos de infección intraabdominal grave y oliguria. Los estudios radiológicos mostraron absceso intraabdominal, y se encontró estenosis casi completa del conducto ileal, que se trató conservadoramente mediante una nefrostomia bilateral. Después de ser dado de alta ocurrió la caída accidental de la nefrostomía derecha, recogiendo cantidades normales de orina por la única nefrostomía izquierda. Se comprobó la existencia de una transuretero-ureterostomía espontánea, con estenosis de la porción distal del conducto ileal. Desde entonces permanece con la nefrostomía, que se cambia periódicamente y en cuatro años de seguimiento no ha tenido deterioro renal significativo. Comentario: El origen de esta estenosis se atribuye a los cambios inflamatorios o inmunológicos en la pared del segmento intestinal, inducidos por la presencia crónica de la orina. Nuestro caso es singular por el curioso resultado de una transuretero- ureterostomía in situ y por el largo seguimiento conservador que se hizo, en un paciente que mantiene una calidad de vida buena (AU)

Introduction: Stenosis of an ileal conduit is a rare complication of this urinary diversion. In the case here described, such a complication was neglected for some weeks and left the patient in a high risk situation. After implantation of a bilateral nephrostomy, a spontaneous transuretero-ureterostomy was found. Clinical case: A 70-year-old man with an ileal conduit performed 15 years before because of bladder tumour, was admitted with signs of severe intraabdominal infection and oliguria. The image studies shown intraabdominal abscess, and an almost complete stenosis of the ileal conduit, that was conservatively treated with a bilateral percutaneous nephostomy. After discharged, he reported an accidental falling-out of the right nephrostomy, collecting normal diuresis from the only left nephrostomy. The spontaneous appearance of a transuretero-ureterostomy was demonstrated. The patient refused surgery and remained with a nephrostomy that is periodically changed, and after four years of follow-up he has neither significant kidney dysfunction nor other incidences. Comment: The origin of this ileal conduit stenosis is related to the inflammatory or immunologic changes induced by the chronic presence of the urine on the wall of the intestinal segment. This case is singular because of the curious result of an in situ transuretero-ureterostomy, and because of the long conservative follow-up, without significant complications, in a patient that keeps a good quality of life (AU)

Modified ureterosigmoidostomy for management of malignant and non-malignant conditions.

OBJECTIVE: To investigate the outcome of Mainz Pouch II urinary diversion for both malignant and non-malignant diseases. DESIGN: A retrospective analysis. SETTING: Kilimanjaro Christian Medical Centre, Institute of Urology, Moshi, Tanzania from April 1995 to May 2007. PATIENTS: Mainz Pouch II was created in 83 patients of which, 38 were females and 45 were males (M:F 1.2:1). RESULTS: Early complications were seen in 11 (13.2%) patients, as follows: one (1.2%) prolonged ileus, 1(1.2%) wound dehiscence, two (2.4%) perioperative deaths among the malignant group, seven (8.4%) superficial wound sepsis. Long term complications were seen in 14 (16.9%) patients, as follows: one (1.2%) patient developed an incision hernia, one (1.2%) patient developed unilateral pyelonephritis, one (1.2%) patient developed unilateral ureteral stenosis, two (2.4%) patients had deterioration of renal function, three (3.6%) patients developed mild to moderate unilateral hydronephrosis, three (3.6%) patients developed mucoceles. Among the 83 patients in this series, three (3.6%) patients developed metabolic acidosis, two (2.4%) of which, required oral bicarbonate supplementation. All (100%) patients had daytime continence while three (3.6%) patients had occasional night time incontinence. Overall total continence was achieved in 80 (96.4%) of the patients. CONCLUSION: The Mainz Pouch II is a safe and reproducible method of urinary diversion and serves as a satisfying method of continent urinary diversion in all age groups. This reconstructive surgery enabled the afflicted to achieve personal goals, hopes and aspirations, positively influencing their quality of life. The follow up show low complication rate with good results in terms of continence and quality of life, however, long term results remain to be evaluated.

[Long-term experience with Cohen ureteral reimplantation in bilateral vesicoureteral reflux in childhood]. / Langzeiterfahrungen mit der Ureterozystoneostomie nach Cohen beim bilateralen vesikoureterorenalen Reflux im Kindesalter.

INTRODUCTION: In bilateral VUR, Cohen cross-trigonal ureteric reimplantation is a popular but also controversial surgical approach. We present our own experience in a retrospective analysis. PATIENTS AND METHODS: Between 1990 and 2005, 41 children (26 girls, 15 boys) with bilateral reflux [92 renal units (RU)] underwent ureteric reimplantation. The mean age was 4.5 (0.3-12) years. Eight patients had ureteral duplication (six unilateral, two bilateral); 12 of 41 patients had no intraoperative ureteral stenting. Seven patients had prior surgery for VUR. A successful result was defined as absence of VUR, significant UVJ obstruction, or voiding dysfunction throughout the follow-up. RESULTS: The mean follow-up was 7.8 (0.5-15) years. Eight patients (19.5%) had 13 complications. One patient had an intraoperative small bowel lesion (2%). Six patients (14.6%) had UTI. Four patients (9.8%) showed transient UVJ obstruction. Three required a temporary percutaneous nephrostomy. Two of these patients had no intraoperative ureteral stenting. Recurrence of VUR was found in 2 patients (4.8%) and 2/92 RU (2.2%), respectively. Complications were more frequent in high-grade VUR, ureter duplex, or unstented ureteral reimplantation. Prior surgery for VUR did not influence the postoperative outcome. Postoperative voiding disorders were not observed. CONCLUSIONS: Two unilateral recurrences of VUR were observed, requiring a reoperation in one patient. A reoperation for UVJ obstruction was not necessary. Related to 92 RU the surgical success rate was 97.8%. Intraoperative ureteral stenting has to be considered with respect to the current discussion of shortening inpatient procedures. In our experience, the perioperative risk was elevated in patients with high-grade VUR or ureteral duplication.

A simple design for a stoma flange cutter.

Several stoma flange cutters have been described, however it appears that there is limited awareness of their existence by doctors, stoma care nurses or patients. In this article a simple design for a stoma flange cutter is described.

Utility of an atraumatic self-retaining ring retractor in pediatric surgery.

The Protractor is a self-retaining ring retractor used mainly for minilaparotomies in adults. We report our positive results of using this retractor in pediatric surgery. We performed surgery with the aid of the Protractor in 57 pediatric patients aged from 1 day old to 16 years old. The Protractor allowed a wide operative view and did not cause any major complications. It was especially useful for Kasai's portoenterostomies and ureteroneocystostomy (Cohen's repair). In neonatal surgery, the Protractor not only provided a wide operative view, but also prevented the washing fluid from overflowing onto the covering sheet. In appendectomy, the Protractor protected the surgical wound from contaminated ascites and the appendix. The Protractor is a very useful tool for assisting with various abdominal operations in infants and children.

Result of endoscopic ureteroureterostomy with holmium:YAG laser for complete ureteral obstruction.

BACKGROUND AND PURPOSE: Complete ureteral obstruction after pelvic surgery is traditionally managed by open repair. Recent advances in endoscopic instruments and techniques have improved the efficacy with which these conditions are treated. Here, we describe our experiences with a holmium:YAG laser in the endoscopic management of complete ureteral obstruction. PATIENTS AND METHODS: Retrograde endoscopic ureteroureterostomy using a Ho:YAG laser was performed on five patients with complete ureteral obstruction having a mean length of 0.9 +/- 0.2 cm after gynecologic surgery. The obliterated segment was incised with a 550-microm fiber through a rigid ureteroscope and under fluoroscopic guidance. Afterward, balloon dilatation was performed. A 7F/14F endopyelotomy stent was maintained for a mean time of 7 weeks, and follow-up was conducted via radiologic imaging. RESULTS: Recanalization was possible in all five patients immediately. One month after the initial operation, one patient exhibited a normal ureteral passage, and three other patients exhibited partial ureteral stricture. The remaining patient was lost to follow-up. Of the three patients with partial strictures, two evidenced no stricture after additional endoscopic treatment(s), and the remaining patient eventually underwent open repair. Overall, three of four (75%) patients exhibited normal excretory function without any open surgery and were symptom free with a mean follow-up time of 45 months (range 23-67 months). CONCLUSIONS: Although the number of patients in this study was small, it appears that endoscopic ureteroureterostomy with a Ho:YAG laser may constitute a valuable option for the treatment of complete short ureteral obstructions.

Laparoscopic ureterocalicostomy: development of a technique simplified by application of Nitinol clips and a wet monopolar electrosurgery device.

PURPOSE: We developed a technique for laparoscopic ureterocalicostomy with the use of intracorporeal suturing and subsequently simplified the technique by application of experimental Nitinol clips. MATERIALS AND METHODS: We performed laparoscopic ureterocalicostomy on 16 domestic swine divided into four groups of four animals each. The kidney was exposed laparoscopically, and the renal artery was atraumatically clamped. The lower pole of the kidney was amputated to expose a lower-pole calix, and hemostasis of the cut renal surface was obtained with a wet monopolar electrosurgical device (Floating Ball device [FB]; TissueLink, Dover, NH). Anastomosis of the ureter to the lower-pole calix was performed over a guidewire using 3-0 Vicryl suture in group 1 and Nitinol clips in group 3. A double-J ureteral stent was then deployed retrograde under fluoroscopic guidance. In addition, we evaluated the use of fibrin glue as a sealant over the sutured or clipped anastomotic site (groups 2 and 4, respectively). Ureteral stents were removed after 3 weeks, and the animals were evaluated and sacrificed after an additional 3 weeks. RESULTS: Laparoscopic ureterocalicostomy was completed in all 16 animals. In each case, excellent renal parenchymal hemostasis was obtained with the FB device, with a mean hemostasis time of 4.1 minutes. The mean anastomotic time with standard suture reconstruction was 37.1 +/- 5.4 minutes, while the anastomotic time with the Nitinol clips was 29.0 +/- 8.0 minutes (P = 0.0339). Retrograde pyelograms in groups 1 and 3 (no fibrin glue) showed a patent anastomosis with no hydronephrosis in three of the four animals in each group. One animal in group 1 and one animal in group 3 developed large urinomas secondary to anastomotic failure. The animals that received fibrin glue over the anastomotic site (groups 2 and 4) all showed narrowed anastomoses with severe hydronephrosis. CONCLUSIONS: With available instrumentation, laparoscopic ureterocalicostomy is technically feasible. Nitinol clip technology significantly reduces collecting-system reconstruction time. Application of fibrin glue as a urinary tract sealant resulted in an unexpected adverse outcome.