Critical Analysis of Early Recurrence after Laparoscopic Radical Cystectomy in a Large Cohort by the ESUT.

PURPOSE: We analyze patients with early progression after laparoscopic radical cystectomy in a large cohort by the ESUT (European Association of Urology Section of Uro-Technology). More specifically we focus on patients with favorable pathology (pT2 N0 R0 or less) who experienced an unexpected recurrence and analyze possible causes for such early recurrence, discussing the surgical technique including pneumoperitoneum. MATERIALS AND METHODS: Since 2000 the ESUT has been constructing a large, multicenter, prospective database of patients undergoing laparoscopic radical cystectomy. All procedures were performed via a standard laparoscopic approach without robotic assistance. We specifically analyzed patients with favorable pathological characteristics, in particular pT2 N0 R0 or less, and evaluated those with progression despite these favorable characteristics. Univariate and multivariate logistic regression was performed to evaluate risk factors for early recurrence. RESULTS: A total of 627 patients were available for final analysis with a median followup of 46 months (mean 57). Of these patients 311 had favorable pathological characteristics of pT2 N0 R0 or less. During followup 27 (8.7%) patients experienced disease progression during the first 24 months. Surgical negligence was found in only 1 case. Most of these patients with early recurrence had progression to high tumor volume disseminated metastatic disease. On multivariate logistic regression tumor stage was the only factor significantly associated with early recurrence (p=0.027). CONCLUSIONS: We report early unexpected recurrences after laparoscopic radical cystectomy in nearly 5% of our entire cohort, all in patients with favorable pathological characteristics (pT2 N0 R0 or less). Pneumoperitoneum may have had a role in the development of these relapses. Specifically designed studies are necessary to investigate the possible role of pneumoperitoneum in urothelial cancer recurrence.

The morbidity of laparoscopic radical cystectomy: analysis of postoperative complications in a multicenter cohort by the European Association of Urology (EAU)-Section of Uro-Technology.

PURPOSE: To analyze postoperative complications after laparoscopic radical cystectomy (LRC) and evaluate its risk factors in a large prospective cohort built by the ESUT across European centers involved in minimally invasive urology in the last decade. METHODS: Patients were prospectively enrolled, and data were retrospectively analyzed. Only oncologic cases were included. There were no formal contraindications for LRC: Also patients with locally advanced tumors (pT4a), serious comorbidities, and previous major abdominal surgery were enrolled. All procedures were performed via a standard laparoscopic approach, with no robotic assistance. Early and late postoperative complications were graded according to the modified Clavien-Dindo classification. Multivariate logistic regression was performed to explore possible risk factors for developing complications. RESULTS: A total of 548 patients were available for final analysis, of which 258 (47%) experienced early complications during the first 90 days after LRC. Infectious, gastrointestinal, and genitourinary were, respectively, the most frequent systems involved. Postoperative ileus occurred in 51/548 (9.3%) patients. A total of 65/548 (12%) patients underwent surgical re-operation, and 10/548 (2%) patients died in the early postoperative period. Increased BMI (p = 0.024), blood loss (p = 0.021), and neoadjuvant treatment (p = 0.016) were significantly associated with a greater overall risk of experiencing complications on multivariate logistic regression. Long-term complications were documented in 64/548 (12%), and involved mainly stenosis of the uretero-ileal anastomosis or incisional hernias. CONCLUSIONS: In this multicenter, prospective, large database, LRC appears to be a safe but morbid procedure. Standardized complication reporting should be encouraged to evaluate objectively a surgical procedure and permit comparison across studies.

Long-term analysis of oncological outcomes after laparoscopic radical cystectomy in Europe: results from a multicentre study by the European Association of Urology (EAU) section of Uro-technology.

OBJECTIVE: To report long-term outcomes of laparoscopic radical cystectomy (LRC) in a multicentre European cohort, and explore feasibility and safety of LRC. PATIENTS AND METHODS: This study was coordinated by European Association of Urology (EAU)-section of Uro-technology (ESUT) with nine centres enrolling 503 patients undergoing LRC for bladder cancer prospectively between 2000 and 2013. Data were retrospectively analysed. Descriptive statistics were used to explore peri- and postoperative characteristics of th ecohort. Kaplan-Meier curves were constructed to evaluate recurrence-free survival (RFS), cancer-specific survival (CSS) and overall survival (OS). Outcomes were also stratified according to tumour stage, lymph node (LN) involvement and surgical margin status. RESULTS: Minor complications (Clavien I-II) occurred in 39% and major (IIIa-IVb) in 17%. In all, 10 (2%) postoperative deaths were recorded. The median (interquartile, IQR) LN retrieval was 14 (9-17) and positive surgical margins were detected in 29 (5.8%) patients. The median (mean, IQR) follow-up was 50 (60, 19-90), during which 134 (27%) recurrences were detected. Actuarial RFS, CSS and OS rates were 66%, 75% and 62% at 5 years and 62%, 55%, 38% at 10 years. Significant differences in RFS, CSS and OS were found according to tumour stage, LN involvement and margin status (log-rank P < 0.001). On multivariate Cox analysis, T stage and LN involvement (both P < 0.001) were significant predictors of RFS, CSS and OS. Positive margins were significant predictors of RFS (P = 0.016) and CSS (P = 0.043). CONCLUSIONS: In this European LRC multicentre study, the largest to date, long-term RFS, CSS and OS rates after LRC appear comparable to those reported in current open RC series. Further randomised controlled trials are necessary to assess the global impact of LRC.

Robotic-assisted laparoscopic retrieval of a migrated IUCD in the pelvis.

Intrauterine contraceptive devices (IUCDs) are a popular treatment choice for contraception. We report a case of a woman in her forties who presented to a urology clinic with visible haematuria. Flexible cystoscopy revealed a bladder lesion, suspicious for a tumour. However, subsequent imaging determined that this was in fact the arm of an IUCD, sited 7 years previously, which had migrated into the bladder. The patient underwent an uneventful robotic-assisted laparoscopic removal of the device. IUCD-related complications are infrequent and can present atypically, warranting a broad diagnostic approach. Robotic-assisted laparoscopic removal of devices migrating into pelvic structures offers all the advantages of minimally invasive surgery, with the added benefits of three-dimensional views and endowrist movement facilitating tasks such as intracorporeal suturing. We report the first documented case of utilizing the da Vinci robotic system in safely assisting the removal of a migrated IUCD.

Long-term Oncological Outcomes from an Early Phase Randomised Controlled Three-arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL).

BACKGROUND: The long-term oncological outcomes of laparoscopic (LRC) and robotic-assisted radical cystectomy (RARC) are still maturing compared with open radical cystectomy (ORC). OBJECTIVE: To evaluate the 5-yr oncological outcomes of patients recruited into the randomised trial of Open, Laparoscopic and Robot Assisted Cystectomy (CORAL) and extracorporeal urinary diversion. DESIGN, SETTING, AND PARTICIPANTS: A review of prospectively maintained database of 60 patients with muscle-invasive bladder cancer (MIBC) or high-risk nonmuscle-invasive bladder cancer (HRNMIBC) who were previously randomised in the CORAL trial to receive ORC, RARC, or LRC. This trial was designed to compare the perioperative and early oncological outcomes of these techniques. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The outcomes of interest included 5-yr recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS). Kaplan-Meier curves were used to plot the recurrence and survival data. The curves between RFS, CSS, and OS were compared using the log-rank test. A two-sided p value <0.05 was considered significant. Results were analysed on the basis of intention to treat. RESULTS AND LIMITATIONS: A total of 60 patients with either MIBC (n=38) or HRNMIBC (n=21) were randomised in the CORAL trial to receive ORC, RARC, or LRC. The 5-yr RFS was 60%, 58%, and 71%; 5-yr CSS was 64%, 68%, and 69%; and 5-yr OS was 55%, 65%, and 61% for ORC, RARC, and LRC, respectively. There was no significant difference in RFS, CSS, and OS between the three surgical arms. The principal limitation is the small sample size. CONCLUSIONS: There was no difference in 5-yr RFS, CSS, and OS rates of patients who underwent ORC, RARC, and LRC for management of bladder cancer. Minimally invasive techniques achieved equivalent oncological outcomes to the gold standard of ORC. However, the study was based at a single institution with a small sample size. PATIENT SUMMARY: Patients who agreed to participate in the randomised trial of either open, laparoscopic, or robotic-assisted radical cystectomy for bladder cancer did not have different cancer outcomes at 5yr.

Single-port 'scarless' laparoscopic nephrectomies: the United Kingdom experience.

OBJECTIVE: To present the UK experience to date with laparoendoscopic single-site surgery (LESS) simple nephrectomy. PATIENTS AND METHODS: Five female patients underwent LESS nephrectomy; three procedures were carried out with the umbilicus as the port of entry (U-LESS). RESULTS: All cases were completed uneventfully. The operative duration was 45-150 min and blood loss was negligible. There were no conversions to conventional multi-port laparoscopy or open surgery. Recovery was uneventful with only minor complications in two patients; convalescence was rapid. CONCLUSION: LESS nephrectomy offers a safe, cosmetic alternative to conventional multi-port laparoscopy, with younger female patients being especially happier with the 'scarless' outcome of U-LESS. LESS certainly appears to be more in these situations.

Evaluation of a commercial vascular clip: risk factors and predictors of failure from in vitro studies.

OBJECTIVE: To assess risk factors and predictors of failure of the Hem-o-lok(TM) vascular clip (Weck Closure Systems, Research Triangle Park, NC, USA) using vessels harvested from a porcine model. MATERIALS AND METHODS: Vessels of various diameters were harvested from a porcine model, clipped at 90 degrees or 45 degrees using the Hem-o-lok clip and then cut either flush or with a 1-mm cuff. The vessels were then connected to a burst-pressure device and pressures required to burst the clip or to cause it to leak were measured. RESULTS: The Hem-o-lok clip leaked or burst when the vessel to which it was applied was cut flush. The clip became even more likely to fail if the angle of application of the clip was not at 90 degrees to the vessel surface. CONCLUSION: The Hem-o-lok vascular clip is safe if it is applied at 90 degrees to the vessel surface and, more importantly, if a 1-mm cuff is left between the clip and the point at which the vessel is divided. We would therefore discourage the practice of not leaving this cuff of tissue, in an attempt to maximize vessel length during laparoscopic donor nephrectomy.

A Single-centre Early Phase Randomised Controlled Three-arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL).

BACKGROUND: Laparoscopic radical cystectomy (LRC) and robot-assisted radical cystectomy (RARC) are increasingly popular, but high-level evidence for these techniques remains lacking. OBJECTIVE: To compare the outcomes of patients undergoing open radical cystectomy (ORC), RARC, and LRC. DESIGN, SETTING, AND PARTICIPANTS: From March 2009 to July 2012, 164 patients requiring radical cystectomy for muscle-invasive bladder cancer or high-risk non-muscle-invasive bladder cancer were invited to participate, with an aim of recruiting 47 patients into each arm. Overall, 93 were suitable for trial inclusion; 60 (65%) agreed and 33 (35%) declined. INTERVENTION: ORC, RARC, or LRC with extracorporeal urinary diversion. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary end points were 30- and 90-d complication rates. Secondary end points were perioperative clinical, pathologic, and oncologic outcomes, and quality of life (QoL). The Fisher exact test and analysis of variance were used for statistical analyses. RESULTS AND LIMITATIONS: The 30-d complication rates (classified by the Clavien-Dindo system) varied significantly between the three arms (ORC: 70%; RARC: 55%; LRC: 26%; p=0.024). ORC complication rates were significantly higher than LRC (p<0.01). The 90-d complication rates did not differ significantly between the three arms (ORC: 70%; RARC: 55%; LRC 32%; p=0.068). Mean operative time was significantly longer in RARC compared with ORC or LRC. ORC resulted in a slower return to oral solids than RARC or LRC. There were no significant differences in QoL measures. Major limitations are the small sample size and potential surgeon bias. CONCLUSIONS: The 30-d complication rates varied by type of surgery and were significantly higher in the ORC arm than the LRC arm. There was no significant difference in 90-d Clavien-graded complication rates between the three arms. PATIENT SUMMARY: We compared patients having open, robotic, or laparoscopic bladder removal surgery for bladder cancer and found no difference in Clavien-graded complication rates at 90 d.

Delayed bowel perforation following suprapubic catheter insertion.

BACKGROUND: Complications of suprapubic catheter insertion are rare but can be significant. We describe an unusual complication of a delayed bowel perforation following suprapubic catheter insertion. CASE PRESENTATION: A gentleman presented with features of peritonitis and feculent discharge along a suprapubic catheter two months after insertion of the catheter. CONCLUSION: Bowel perforation is the most feared complication of suprapubic catheter insertion especially in patients with lower abdominal scar. The risk may be reduced with the use of ultrasound scan guidance.

Long-term outcomes of robot-assisted radical cystectomy for bladder cancer.

BACKGROUND: Long-term oncologic and functional outcomes after robot-assisted radical cystectomy (RARC) for bladder cancer (BCa) are lacking. OBJECTIVE: To report oncologic and functional outcomes in a cohort of patients who have completed a minimum of 5 yr and a maximum of 8 yr of follow-up after RARC and extracorporeal urinary diversion. DESIGN, SETTING, AND PARTICIPANTS: In this paper, we report on the experience from one of the first European urology centres to introduce RARC. Only patients between 2004 and 2006 were included to ensure follow-up of ≥ 5 yr. We report on an analysis of oncologic outcomes in 14 patients (11 males and 3 females) with muscle-invasive/high-grade non-muscle-invasive or bacillus Calmette-Guérin-refractory carcinoma in situ who opted to have RARC. INTERVENTION: RARC with pelvic lymphadenectomy was performed using the three-arm standard da Vinci Surgical System (Intuitive Surgical, CA, USA). Urinary diversion, either ileal conduit (n=12) or orthotopic neobladder (n=2), was constructed extracorporeally. OUTCOME MEASUREMENTS: Parameters were recorded in a prospectively maintained database including assessment of renal function, overall survival, disease-specific survival, development of metastases, and functional outcomes. STATISTICAL ANALYSIS: Results were analysed using descriptive statistical analysis. Survival data were analysed and presented using the Kaplan-Meier survival curve. RESULTS AND LIMITATIONS: Five of the 14 patients have died. Three patients died of metastatic disease, and two died of unrelated causes. Two other patients are alive with metastases, and another has developed primary lung cancer. Six patients are alive and disease-free. These results show overall survival of 64%, disease-specific survival of 75%, and disease-free survival of 50%. None of the patients had deterioration of renal function necessitating renal replacement therapy. Three of four previously potent patients having nerve-sparing RARC recovered erectile function. The study is limited by the relatively small number of highly selected patients undergoing RARC, which was a novel technique 8 yr ago. The standard da Vinci Surgical System made extended lymphadenectomy difficult. CONCLUSIONS: Within limitations, in our experience RARC achieved excellent control of local disease, but the outcomes in patients with metastatic disease seem to be equivalent to the outcomes of open radical cystectomy.

Analysis of early complications of robotic-assisted radical cystectomy using a standardized reporting system.

OBJECTIVE: To analyze the early complications of robotic-assisted laparoscopic radical cystectomy (RARC) with extracorporeal ileal conduit or orthotopic (Studer) bladder reconstruction using the Clavien Classification, the management of these complications, and possible preventive measures. MATERIALS AND METHODS: Detailed data on all patients undergoing RARC were recorded prospectively on an encrypted database, including intraoperative or postoperative complications within 90 days of surgery. Outcome data during follow-up of up to 4 years was also collected prospectively. RESULTS: A total of 50 patients (M:F 44:6) underwent RARC and extracorporeal ileal conduit urinary diversion (n = 45) or orthotopic bladder reconstruction (n = 5) between 2004 and 2008. The overall perioperative complication rate was 17 of 50 (34%), including 3 (6%) Clavien I, 9 (18%) Clavien II, and 5 (10%) Clavien III. Final histology showed 9 (18%) patients had no residual disease pT0, 7 (14%) pTa, 11 (22%) pT1, 9 (18%) pT2, 11 (22%) pT3, and 3 (6%) pT4. CONCLUSION: Radical cystectomy remains a complex and morbid procedure with significant complication rate regardless of surgical approach. Using the Clavien reporting system, we identified early complications in 34% of patients, of which five required a significant intervention. Use of this standardized reporting system has allowed us to stratify complications after RARC, allowing easy comparison to other techniques and targeting further reductions in the future.

Evaluation of a hemostatic sponge (TachoSil) for sealing of the renal collecting system in a porcine laparoscopic partial nephrectomy survival model.

OBJECTIVE: The objective of this study was to evaluate the efficacy of TachoSil (Nycomed UK, Oxford, Buckinghamshire, UK), a hemostatic sponge, to seal major collecting system injuries (in addition to providing an adjunct to hemostasis) after partial nephrectomy in a porcine chronic survival model. MATERIALS AND METHODS: Laparoscopic upper-pole partial nephrectomies were performed in 10 farm pigs (>40 kg). After hilar clamping, an energyless incision was made at a point halfway between the hilum and the upper pole of the kidney and the collecting system was opened widely. TachoSil was applied to cover the defect; 15 to 20 minutes after the application of TachoSil, the hilar clamp was removed, hemostasis confirmed, and the pig survived. Assessment was made for hematoma and urinoma. Four weeks postoperatively, the pigs were euthanized. Ex-vivo retrograde studies were performed to assess collecting system leak. Weight, blood pressure, estimated blood loss, the weight of the partial and completion nephrectomy specimen, presence/absence of urinary leak on retrograde study, histopathologic findings, and complications were recorded. RESULTS: All pigs survived. Mean warm ischemia time was 18 minutes, mean blood loss was 90 mL, and mean resected weight was 13.7 g. There was no evidence of leak on retrograde study. Histologically, nonspecific changes were noted in all specimens, which included dystrophic calcification, scarring, and areas of fibrosis at the partial nephrectomy surgical margin. CONCLUSION: TachoSil seals the collecting system after partial nephrectomy on a porcine chronic survival model, in addition to providing an adjunct to hemostasis. More studies, including human trials, are warranted to evaluate this observation further.

The learning curve of robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium.

BACKGROUND: Robot-assisted radical cystectomy (RARC) has evolved as a minimally invasive alternative to open radical cystectomy for patients with invasive bladder cancer. OBJECTIVE: We sought to define the learning curve for RARC by evaluating results from a multicenter, contemporary, consecutive series of patients who underwent this procedure. DESIGN, SETTING, AND PARTICIPANTS: Utilizing the International Robotic Cystectomy Consortium database, a prospectively maintained and institutional review board-approved database, we identified 496 patients who underwent RARC by 21 surgeons at 14 institutions from 2003 to 2009. MEASUREMENTS: Cut-off points for operative time, lymph node yield (LNY), estimated blood loss (EBL), and margin positivity were identified. Using specifically designed statistical mixed models, we were able to inversely predict the number of patients required for an institution to reach the predetermined cut-off points. RESULTS AND LIMITATIONS: Mean operative time was 386 min, mean EBL was 408 ml, and mean LNY was 18. Overall, 34 of 482 patients (7%) had a positive surgical margin (PSM). Using statistical models, it was estimated that 21 patients were required for operative time to reach 6.5h and 8, 20, and 30 patients were required to reach an LNY of 12, 16, and 20, respectively. For all patients, PSM rates of <5% were achieved after 30 patients. For patients with pathologic stage higher than T2, PSM rates of <15% were achieved after 24 patients. CONCLUSIONS: RARC is a challenging procedure but is a technique that is reproducible throughout multiple centers. This report helps to define the learning curve for RARC and demonstrates an acceptable level of proficiency by the 30th case for proxy measures of RARC quality.

The Eastbourne extraction: forceps removal of large laparoscopic nephrectomy specimens without morcellation.

Intact specimen retrieval after laparoscopic nephrectomy for renal tumors is considered the gold standard. Removal of large specimens can be a challenge. A technique to aid large bagged specimen removal using Wrigley's obstetric forceps is described.

Laparoscopy extirpative renal surgery in the octogenarian population.

PURPOSE: Laparoscopic extirpative surgery for cancer is usually safe and effective, even in the elderly. However, the risk to benefit ratio of laparoscopic nephrectomies in patients aged over 80 has not been quantified objectively. The purpose of this study is to analyze the outcomes of this technique in the octogenarian population. MATERIALS AND METHODS: Between July 2001 and March 2008, 37 laparoscopic nephrectomies were performed for malignancy in patients over the age of 80. Patient demographics and perioperative and postoperative data were analyzed retrospectively. RESULTS: Population characteristics include a median age of 82, 65% female with a median American Society of Anesthesiologists score of 2. In all, 57% of the laparoscopic nephrectomies were left sided. Twenty-four laparoscopic nephrectomies were for renal cell carcinoma, with 13 nephroureterectomies for transitional cell carcinoma. A total of 32% had postoperative complications, three of which resulted in death. Average total length of hospital stay was 10.5 days. Stage of malignancy varied from pT(a) to pT(4), and the mean size of the specimen was 169 x 77 mm with a mean tumor size of 54 x 44 mm. At 1 year follow-up (n = 27), 85% were alive, and at 3 years (n = 21) 52% were alive and free of disease. CONCLUSION: Our small study suggests that laparoscopic nephrectomy in this age group is feasible, although the results are far from ideal. Cancer-specific survival rates are poor in this population, and therefore the risk to benefit ratio should be weighed up carefully prior to committing a patient in this age group to extirpative surgery.

Robotic-assisted radical cystectomy.

OBJECTIVE: To evaluate the emerging role of robotic-assisted radical cystectomy (RARC) in the management of bladder cancer. METHODS: Review of the published literature on robotic-assisted radical cystectomy, including data from our cystectomy series of 30 patients. RESULTS: Nearly 150 procedures have been performed worldwide. The benefits of robotic-assisted operations are similar to those of laparoscopically-performed procedures. RARC appears to be technically safe, oncologically and functionally equivalent to open (ORC) and laparoscopic radical cystectomy (LRC). However, RARC offers superior ergonomics and better vision. These benefits come at extra initial capital expenditure and subsequent higher maintenance costs. CONCLUSION: With the rapid spread of robotics, it is likely that RARC will become the standard of care in units with access to the technology.