4. Discussion
bleb on the bowel wall, UEA strictures was small, UEA stricture, infections, ureteral stricture disease
URINARY STRICTURE, INFECTIONS, COMPLICATION, STRICTURES, COMPLICATIONS
Our study supported our hypothesis of improved endoscopic anastomotic detection of the UEA; however, there was a Clavien–Dindo IIIb complication in our small sample size. The operating surgeon felt that the ink contributed to the impaired tissue integrity of the bowel. This combined with the higher rate of ureteral stricture disease led the team to decide that the risks of this technique outweighed the potential benefits. Additionally, we had personal correspondence with staff at an outside institution who also halted their trial due to the accrual of safety concerns (unpublished data).Complications are common following cystectomy and urinary diversion, with both stones and UEA strictures occurring in upwards of 11% of patients following urinary diversion [Overall, ink tattooing supported the easier endoscopic identification of UEA sites. UEA were identified in 100% of the ink cohort compared to 75% of the control group. The two groups had similar overall complications rates, with the most common complications being infections. While it is not statistically significant, the ink patients had a higher UEA stricture rate compared to that of the control group (The ink cohort had a higher UEA stricture rate than our prior published institutional rate of UEA stricture (6%) which was more in concert with the rates cited in the literature [While the number of UEA strictures was small, there was a unanimous agreement amongst the surgeons that there was a possibility that the ink had negatively impacted these patient’s outcomes. The surgeon who performed the open ureteral reimplantation hypothesized that the ink had compromised the IC bowel integrity and lead to a ureteral leak, and ultimately, the UEA stricture. Out of an abundance of caution, the trial was halted early to ensure patient safety. The surgeons reported that it was difficult to control the distribution of the ink as it was injected and that it appeared to form a bleb on the bowel wall. This may be due to using too many injections (three), too much ink, or an overly large needle. Having used the same injection protocol described in McCormick et al. [The limitations of this study include its small sample size due to the trial ending early. However, we did assess 44 renal units. As a result, our treatment and control groups differed significantly in age and in CCI score, despite randomization. Prior studies have not found age to be a predictor of urinary strictures, but they have found strictures to occur at a higher rate in males, patients with a higher BMI, and patients with grade 3 or higher Clavien–Dindo complications within 30 days of their urinary diversion [