The role of ureteric indocyanine green fluorescence in colorectal surgery: a retrospective cohort study.

BACKGROUND: Ureteric injury (UI) is an infrequent but serious complication of colorectal surgery. Prophylactic ureteric stenting is employed to avoid UI, yet its efficacy remains debated. Intraoperative indocyanine green fluorescence imaging (ICG-FI) has been used to facilitate ureter detection. This study aimed to investigate the role of ICG-FI in identification of ureters during colorectal surgery and its impact on the incidence of UI. METHODS: A retrospective cohort study involving 556 consecutive patients who underwent colorectal surgery between 2018 and 2023 assessed the utility of routine prophylactic ureteric stenting with adjunctive ICG-FI. Patients with ICG-FI were compared to those without ICG-FI. Demographic data, operative details, and postoperative morbidity were analyzed. Statistical analysis included univariable regression. RESULTS: Ureteric ICG-FI was used in 312 (56.1%) patients, whereas 43.9% were controls. Both groups were comparable in terms of demographics except for a higher prevalence of prior abdominal surgeries in the ICG-FI group. Although intraoperative visualization was significantly higher in the ICG-FI group (95.3% vs 89.1%; p = 0.011), the incidence of UI was similar between groups (0.3% vs 0.8%; p = 0.585). Postoperative complications were similar between the two groups. Median stent insertion time was longer in the ICG-FI group (32 vs 25 min; p = 0.001). CONCLUSION: Ureteric ICG-FI improved intraoperative visualization of the ureters but was not associated with a reduced UI rate. Median stent insertion time increased with use of ureteric ICG-FI, but total operative time did not. Despite its limitations, this study is the largest of its kind suggesting that ureteric ICG-FI may be a valuable adjunct to facilitate  ureteric visualization during colorectal surgery.

Complete ureteropelvic-junction disruption following renal trauma: conservative management. / Avulsión completa de la unión pieloureteral tras traumatismo renal: manejo conservador.

INTRODUCTION: Surgical exploration in complete ureteropelvic-junction disruption (CUPJD) is still recommended by many authors. Conservative approach to pediatric renal trauma (RT) includes minimally invasive techniques such as nephrostomy, angioembolization or double-J stent placement. CASE REPORT: A 14-year-old patient with CUPJD was treated conservatively. CT-scan revealed active bleeding of the renal artery and significant urine extravasation. Coil angioembolization and nephrostomy placement were performed. An attempt to place a double-J stent was unsuccessful and surgical reconstruction was scheduled. Before surgery, methylene-blue was injected through the nephrostomy observing blue urine output through urethra. Antegrade pyelogram revealed drainage from the urinoma to the ureter. A new attempt to place an internal-external double-J-stent was successful. After 5 weeks, it was removed with total restoration of the urinary tract. CONCLUSION: Complete urinary tract restoration in some cases of CUPJD following RT is possible through a nonoperative approach. It can be safe and effective, reducing the risk of complications associated with complex surgeries.

INTRODUCCION: Muchos autores siguen recomendando la exploración quirúrgica en casos de avulsión completa de la unión pieloureteral (ACUPU). El abordaje conservador del traumatismo renal (TR) pediátrico incluye técnicas mínimamente invasivas como la nefrostomía, la angioembolización o el catéter doble J. CASO CLINICO: Paciente de 14 años con ACUPU tratada de forma conservadora. El escáner reveló la presencia de una hemorragia activa en la arteria renal, además de una importante extravasación urinaria. Se practicó angioembolización con bobinas y nefrostomía. Se intentó colocar un catéter doble J, sin éxito, por lo que se programó reconstrucción quirúrgica. Antes de la cirugía, se inyectó azul de metileno a través de la nefrostomía, observándose salida de orina azul a través de la uretra. La realización de una pielografía anterógrada reveló la presencia de drenaje desde el urinoma hacia el uréter. El segundo intento de colocar un catéter doble J interno-externo sí resultó fructífero, retirándose al cabo de 5 semanas, con restauración total del tracto urinario. CONCLUSION: La restauración completa del tracto urinario en algunos casos de ACUPU tras TR es factible sin necesidad de recurrir al abordaje quirúrgico. Se trata de un proceso seguro y eficaz que disminuye el riesgo de las complicaciones propias de las cirugías complejas.

Acute kidney injury after colorectal surgery with prophylactic ureteral stents.

BACKGROUND: After colorectal surgery, acute kidney injury (AKI) results from a complex interplay of multiple independent causes and preventive measures that occur during the hospitalization. Prophylactic stenting for ureter identification has been identified as a potential cause, but the evidence is conflicting, possibly because of differing baseline characteristics and procedure-related approaches. OBJECTIVE: This retrospective cohort study assesses the role of stents in the etiology of AKI after determining the independent predictors of AKI. METHODS: From a population of 1224 consecutive colorectal patients (from 8/1/2016 through 12/31/2021), 382 (31.2%) received ureteral stents, and propensity score matching was used to create stented and control groups. Emergent cases and patients with sepsis were excluded from the analysis. Previously identified independent predictors of AKI, minimally invasive procedures, and a history of diabetes mellitus were used as criteria to create two balanced groups. RESULTS: Baseline demographic characteristics and procedure-related factors baseline factors were similar between the groups. There was no difference in the rate of AKI between stented patients and controls (P = 0.82), nor was there any difference in postoperative complications, such as chronic renal insufficiency (CRI, P = 0.49), average postoperative creatinine (P = 0.67), urinary tract infections (UTI, P = 0.82), any postoperative infection (P = 0.48), in-hospital complications (P = 1.00), length of stay (LOS, P = 0.15), and 30-day readmissions (P = 0.79). CONCLUSIONS: In a population of patients where stenting was frequently employed, ureter stents placed for identification did not appear to cause AKI or AKI-related complications.

A delayed diagnosis of iatrogenic ureteral injury results in increased morbidity.

This study aimed to register and analyse outcomes after iatrogenic ureteral injuries (IUI) with special emphasis on potential consequences of a delayed diagnosis, and further to analyse if the incidence of IUI has changed during the study period. 108 patients treated for an IUI during 2001-2021 were included. Injuries due to endourological procedures, planned tumour resection and traumatic injuries were excluded. All relevant information to answer the research questions were entered into a database. Chi-square and t-tests were used for categorical and continuous variables respectively. Regression analysis was used to evaluate potential change of incidence in IUIs over time. Our results showed that most IUIs (74, 69%) were caused by gynaecological surgery. 49 (45%) had a delayed diagnosis (not diagnosed intraoperatively). Younger age (mean 50 vs 62 years, p < 0.001) and benign indication for laparoscopic hysterectomy (OR 8.0, p < 0.001) predisposed for a delayed diagnosis. Patients with a delayed diagnosis had a higher number of secondary injury related procedures (mean 4.6 vs 1.7, p < 0.001), hospital admissions (mean 3.0 vs 0.8, p < 0.001) and longer hospital stays (mean 20.6 vs 3.9 days p < 0.001) compared to patients with an intraoperative diagnosis. There was complete recovery for 91% of the patients. We did not observe any changes in IUI incidence during the study period. In conclusion, our study underlines that IUI can cause major morbidity for the patient affected if not diagnosed intraoperatively. Benign indication and younger age are predictors for a delayed diagnosis. The prognosis is good, with 91% full recovery. No significant changes in incidence of IUIs were observed.

The relationship between the force applied and perceived by the surgeon during ureteral access sheath placement: ex-vivo experimental model.

PURPOSE: To define a peak force of insertion (PFOI) threshold for ureteral damage during ureteral access sheath (UAS) placement on an experimental ureteral orifice model. METHODS: A specially designed water tank using 2 laparoscopic 5 mm ports and 2 different size (10 Fr and 8 Fr) sealing cap adaptors (SCA) as ureteral orifices was used to perform the test. A 10-12 Fr UAS was fixed to a load cell and the force of insertion (FOI) was continuously recorded with a digital force gauge.13 experts in the field of endourology who participated performed 3 UAS insertions. The FOI was recorded initially with 10 Fr followed by 8 Fr SCA. On the final insertion, the orifice was obstructed, leaving a 5 cm length to insert the UAS. The experts were asked to "Stop at the point they anticipate ureteral damage, and they would not proceed in real life". RESULTS: Using 10 Fr SCA the PFOI was 2.12 ± 0.58 Newton (N) (range:1.48-3.48) while 8 Fr SCA showed a PFOI 5.76 ± 0.96 N (range:4.05-7.35). Six of the experts, said they would stop proceeding when they reached above 5.1 N. Three experts had PFOI < 5.1 N and the other 4 stated they would go with PFOIs of 5.88, 6.16, 6.69 and 7.35 N when using SCA of 8 Fr.The highest load they would stop proceeding had a PFOI of 6.09 ± 1.87 N (range: 2.53-10.74). CONCLUSION: The PFOI threshold for ureteral damage inserting UAS of the experts is variable. Although FOI is a subjective perception, experience suggests that ureteral injury may occur at an average of 6.05 N perceived by surgeons' tactile feedback. In-vivo measurement of UAS PFOI may confirm a threshold.

Legal Outcomes of Litigation After Iatrogenic Genitourinary Trauma.

OBJECTIVE: To evaluate plaintiff and defendant characteristics associated with iatrogenic genitourinary (GU) trauma litigation and outcomes of closed claims. METHODS: LexisNexis was queried in April 2023 using terms related to GU organs and injury, and manually reviewed for iatrogenic cases. Case details including defendant, organ involvement, and legal outcome were obtained. Multinomial regression analysis was performed to identify factors associated with outcome. RESULTS: Four hundred ten cases involving 611 defendants were identified, with the ureter the most commonly affected organ (202/410, 49.3%). Most cases involved adult plaintiffs (380, 92.7%) and resulted in favor of the defense (227, 55.4%). Injuries resulted most frequently from gynecologic surgeries (179, 43.7%). Defendants were most commonly obstetricians/gynecologists (243/611, 39.8%) and urologists (168, 27.5%). Penile (OR 6.3 [95% CI 2.5-16.1]) and urethral (OR 4.8 [2.0-11.7]) injuries were associated with greater odds of a plaintiff verdict relative to ureter injury. A plaintiff verdict was also more likely when defendants were academic hospitals compared to individual practitioners (OR 4.3 [1.9-9.9]). In cases ruling in favor of the plaintiff, indemnity payments were larger when the defendants were comprised of individual practitioners compared to a hospital or medical group (median $549,613 vs $250,000, P <.001). CONCLUSION: Urologists may be involved in medical malpractice lawsuits for iatrogenic injury even when they are uninvolved in the index procedure. Most cases that reach litigation result in defense verdicts regardless of the GU organ injured. Defendant characteristics associated with plaintiff verdicts are more nuanced, and providers should be aware of potential downstream effects of litigation.

Keep your attention closer to the ureters: Ureterolysis in deep endometriosis surgery.

Endometriosis surgery involving the ureter poses significant challenges requiring meticulous surgical techniques and vigilant postoperative care. This chapter addresses key aspects of ureterolysis techniques, intraoperative management of ureteral injuries, and postoperative care in the context of endometriosis surgery. Ureterolysis methods aim to isolate and mobilize the ureter while preserving its vascularity. Cold instruments and careful dissection are recommended to prevent thermal injury during surgery. Intraoperative tools such as indocyanine green (ICG) show promise in assessing for vascular compromise. Over half of ureteral injuries are detected postoperatively, necessitating a high index of suspicion. Optimal postoperative care in the case of ureteral injury involves Foley catheterization for decompression, ureteral stenting, and meticulous follow-ups to monitor healing and renal function. While advances have been made in surgical techniques and diagnostic tools, gaps persist in preoperative imaging optimization and predictive models for identifying at-risk patients. This chapter aims to bridge existing knowledge gaps, optimize surgical practices, and enhance the overall care and outcomes of patients undergoing endometriosis surgery involving the ureter.

Prophylactic ureteric catheterisation during complex gynaecological surgery: A systematic review and meta-analysis.

BACKGROUND: There is a lack of robust evidence to recommend the use of perioperative ureteric catheterisation or stenting in complex gynaecological surgery. OBJECTIVES: To evaluate the evidence on the benefits and risks of perioperative ureteric catheterisation or stenting in complex gynaecological surgery. SEARCH STRATEGY: A literature search was performed in CINAHL, the Cochrane Library, Embase and MEDLINE, from 1946 to January 2024, using a combination of keywords and Medical Subject Headings (MeSH) terminology. SELECTION CRITERIA: Randomised controlled trials (RCTs) and observational studies were included. DATA COLLECTION AND ANALYSIS: Meta-analysis of the RCTs and observational studies were performed separately. Cochrane RevMan 6.5.1 was used to undertake meta-analysis. Risk ratios with 95% CIs were calculated for the outcome measures. MAIN RESULTS: Ten studies were included: three RCTs and seven observational studies, comprising 8661 patients. The three RCTs, comprising a total of 3277 patients, showed no difference in the risk of immediate complications in the form of ureteric injury between the ureteric stent and the control groups (RR 0.9, 95% CI 0.49-1.65). The observational studies included 5384 patients. Four studies that explored the ureteric injury as an outcome did not show any difference between the two groups (RR 0.76, 95% CI 0.27-2.16). One case-control study with 862 participants found that the rate of ureteric injury was higher in the non-stented group, although this was observed in only three patients. The risk of urinary tract infection (UTI) was increased in the stent group, although not with statistical significance (RR 1.84, 95% CI 0.47-7.17). There was no significant difference in the risk of ureteric fistulae (RR 1.91, 95% CI 0.62-5.83), although the number of studies was limited. CONCLUSIONS: Prophylactic ureteric catheterisation or stenting for complex gynaecological surgery is not associated with a lower risk of ureteric injury.

Can preoperative ureteral stent placement help in the intraoperative identification of iatrogenic ureteral injury?

BACKGROUND: The benefits of prophylactic ureteral stent placement during colorectal surgery remain controversial. This study aimed to determine the incidence of ureteral injury in colorectal operations, assess the complications associated with stent usage, and determine whether their use leads to earlier identification and treatment of injury. METHODS: This was a retrospective study of patients undergoing colorectal abdominal operations between 2015 and 2021. Variables were examined for possible association with ureteral stent placement. The primary study endpoint was ureteral injury identified within 30 days postoperatively. RESULTS: Of 6481 patients who underwent colorectal surgery, 970 (15%) underwent preoperative ureteral stent placement. The use of stents was significantly associated with a higher American Society of Anesthesiologists classification, wound classification, and longer duration of surgery. A ureteral injury was identified in 28 patients (0.4%). Of these patients, 13 had no stent, and 15 had preoperative stents placed. After propensity matching, stent use was associated with an increased risk of hematuria and urinary tract infection. Ureteral injury was identified intraoperatively in 14 of 28 patients (50.0%) and was not associated with ureteral stent use (P = .45). CONCLUSION: Iatrogenic ureteral injury was uncommon, whereas preoperative stent placement was relatively frequent. Earlier recognition of iatrogenic ureteral injury is not an expected advantage of preoperative ureteral stent placement.

Preventing iatrogenic ureteral injury in colorectal surgery: a comprehensive and systematic review of the last 2 decades of literature and future perspectives.

Iatrogenic ureteral injury (IUI) during colorectal surgery is a rare complication but related to a serious burden of morbidity. This comprehensive and systematic review aims to provide a critical overview of the most recent literature about IUI prevention techniques in colorectal surgery. We performed a comprehensive and systematic review of studies published from 2000 to 2022 and assessed the use of techniques for ureteral injury prevention and intraoperative localization. 26 publications were included, divided into stent-based (prophylactic/lighted ureteral stent and near-infrared fluorescent ureteral catheter [PUS/LUS/NIRFUC]) and fluorescent dye (FD) groups. Costs, the percentage and number of IUIs detected, reported limitations, complication rates and other outcome points were compared. The IUI incidence rate ranged from 0 to 1.9% (mean 0.5%) and 0 to 1.2% (mean 0.3%) in the PUS/LUS/NIRFUC and FD groups, respectively. The acute kidney injury (AKI) and urinary tact infection (UTI) incidence rate ranged from 0.4 to 32.6% and 0 to 17.3%, respectively, in the PUS/LUS/NIRFUC group and 0-15% and 0-6.3%, respectively, in the FD group. Many other complications were also compared and descriptively analyzed (length-of-stay, mortality, etc.). These techniques appear to be feasible and safe in select patients with a high risk of IUI, but the delineation of reliable guidelines for preventing IUI will require more randomized controlled trials.

Does preoperative silodosin administration facilitate ureteral dilatation during flexible ureterorenoscopy? A randomized clinical trial.

PURPOSE: To assess whether preoperative administration of silodosin can facilitate the placement of ureteral access sheath (UAS) prior to flexible ureteroscopy (F-URS) and reduce the occurrence of ureteric injury in challenging cases. METHODS: This prospective randomized clinical trial was carried out on 147 patients diagnosed with upper ureteric stone or stone kidney, non-stented. The patients were randomly divided into two equal groups. Group A (silodosin group) included patients in whom F-URS was done with daily preoperative intake of 8 mg silodosin for 1 week and group B (placebo/control group) included patients in whom F-URS was done with daily preoperative intake of placebo tablets. RESULTS: In group A, a total of 23 (33.3%) experienced ureteral wall injury following UAS insertion, while in group B, this occurred in 40 patients (59.7%). There was a statistically significant difference in the grade of ureteral wall injury between the two groups (P < 0.001). In the multiple regression analysis, age, operative time and silodosin were found to be significant risk factors for ureteral wall injury (P = 0.007, 0.041 and < 0.001, respectively). CONCLUSIONS: The administration of silodosin prior to retrograde intrarenal surgery (RIRS) effectively prevented significant ureteral wall damage and reduced initial postoperative discomfort.

Risk stratification of acute kidney injury (AKI) following ureteral stent insertion for colorectal surgery.

INTRODUCTION AND OBJECTIVES: Ureteral stents have long been utilized during colorectal resections to assist in the identification of ureters intraoperatively and mitigate risk of ureteral injury. As these procedures have shifted toward robot-assisted laparoscopic methods, lighted stents have increasingly been used. The incidence of acute kidney injury (AKI) following bilateral ureteral stent placement has been reported to be as high as 41.9%. We sought to identify our single-institution risk and determine the extent to which age, sex, and stent type affected incidence of AKI. METHODS: A retrospective analysis was performed at a single community hospital of all open and robotic-assisted laparoscopic colorectal surgeries from October 2012 to April 2022. If requested, ureteral stents were placed bilaterally by a urologist and later removed by the surgeon. Non-lighted stents used were 5 Fr whistle-tip (BARD); lighted stents were 6 Fr with a fiberoptic core (STRYKER). Kidney failure was described as a rise of creatinine to ≥ 1.5 times the preoperative value, per KDIGO guidelines. RESULTS: 633 consecutive colorectal surgeries were evaluated, with no stents placed in 237 cases, non-lighted stents placed in 137 cases, and lighted stents placed in 259 cases. No ureteral injuries were observed. Overall incidence of AKI for non-stented surgeries was 0.8% vs 5.8% for non-lighted stents and 5.8% for lighted stents. Patient age was the most significant factor in AKI incidence: for patients under 60, there was no statistical difference in AKI incidence for stented vs non-stented procedures (2.2% vs 1.1%). For patients over 60, the risk of AKI was 10.5% for stented vs 0.7% for non-stented. Female patients had statistically significant risk differences, with AKI incidence of 7.1% stented vs 0.0% non-stented. AKI completely resolved in all cases, regardless of cohort. CONCLUSIONS: In patients under age 60, the use of stents was not associated with an increased risk of AKI. For women and those over 60, stents pose a higher risk of transient AKI. Overall incidence of AKI in our larger and single-institution community hospital population was significantly lower than reported in other studies. No statistical difference was observed, overall, in AKI incidence between lighted and non-lighted stents.

Effectiveness and Cost of Stenting in Ureteral Injury in Colorectal Surgeries in the US: 2015 - 2019.

Background: Intraoperative ureteral injury (IUI) during colorectal surgery can have devastating consequences. This study aimed to assess the clinical and economic impact of pre-operative ureteral stenting in colorectal surgeries. Methods: A retrospective cohort study was conducted using United States hospital data (October 2015 - December 2019). IUI incidence was examined across selected inpatient surgery types (elective colectomy, enterectomy, proctectomy, enterostomy, other colorectal procedures; emergency colectomy). Stenting effectiveness was evaluated as the difference in IUI and intraoperative detection rates between propensity score-matched groups. The additional hospital cost for stenting was also estimated considering the savings from IUIs that were potentially avoidable or detected by stenting. Results: In total, 283,549 colorectal surgeries were analyzed. Across surgery types, stent use and IUI incidence ranged from 1.47% - 8.86% and from 0.91% - 2.90%, respectively. Stents were used in 6.75% of elective colectomy cases, where they were associated with an absolute reduction of 1.14 percentage points (95% CI: -1.85 to -1.03) in IUI rate and a 21.6 percentage point reduction in the intraoperative detection rate. Additional hospital costs for stenting ranged from $1,464 - $4,436 across surgery types. Additional results varied by case but were consistent with the colectomy example. Conclusions: While effective in limited settings, the IUI reduction attributed to stenting and ability to shift IUI detection to the intraoperative setting could not offset the hospital cost of stent placement during colectomy (and colorectal surgery, in general). There thus remains an ongoing need in colorectal surgery for a universal, cost-effective solution to prevent IUI.

Iatrogenic Thermal Energy-Induced Distal Ureteric Injury and Its Management by Laparoscopy Ureteroureterostomy.

Background and Objectives: Most thermal energy-induced distal ureter injuries are missed intraoperatively as they are caused by delayed ischemia-induced necrosis of the affected part leading to fistula, and a delayed presentation. The injuries of the distal ureter are commonly managed by ureteroneocystostomy, which has long-term complications related to vesico-ureteric reflux (VUR). We present our experience of management of distal ureter injury due to thermal energy by laparoscopy ureteroureterostomy and the role of various methodologies for its diagnosis. Methods: It is a retrospective, single-center study that was conducted from January 1, 2020 - December, 31 2022. Results: A total of 8 cases were enrolled in the study. All cases had an uterovaginal fistula (UVF) post-laparoscopic gynecology surgery. The bilateral ureteric injury was observed in 2 cases. The median post-surgery time to diagnose UVF in the study was 10 days. All cases were managed by laparoscopy ureteroureterostomy (LUUS). Six cases underwent immediate surgery after the diagnosis; whereas 2 cases had initial double-J stent placement as treatment, which subsequently failed following which the LUUS was performed. There were not any immediate or long-term complications such as leakage, stenosis, fistula, or any requirement for revision surgery. Conclusion: The management of thermal energy-induced ureteric injury is exceptional as compared to other types of ureteric injury. Our approach should be toward immediate surgical management rather than a conservative one to avoid long-term complications and sequelae. Iatrogenic lower ureteral injury can be managed successfully by LUUS, maintaining the normal anatomy and physiology of VUR.

Pre-operative ureteric catherisation for major endoscopic gynaecological surgery.

BACKGROUND: Several strategies have been implemented to better identify the course of the ureters intra-operatively due of the morbidity associated with ureteric injuries especially during gynaecological surgery. We described our experience with pre-operative ureteric catherisation in women who underwent major endoscopic gynaecological surgery. METHODS: A case-controlled study of 862 women who underwent major endoscopic gynaecological surgery sourced from two health institutions were conducted. Two groups were compared: those who had pre-operative prophylactic ureteric catherisation (study group) and those who had routine cystoscopy performed immediately post surgery (control group). RESULTS: There were no intra-operative ureteric injuries or associated complications noted in the study group. When compared to the control group, length of hospital stay (2 days vs 5 days; p < 0.05) and overall mean time for cystoscopy (11 min vs 35 min; p < 0.05) was significantly shorter in the study group. There was no long-term morbidity recorded in the study group. CONCLUSION: Our experiences with prophylactic pre-operative bilateral ureteric catheterisation for major endoscopic gynaecological surgeries were favourable and are associated with low complication rates. Routine or adjunct use before major gynaecological and pelvic surgery combined with meticulous surgical technique can help reduce iatrogenic and unintentional ureteric injuries.

Pudexacianinium (ASP5354) chloride for ureter visualization in participants undergoing laparoscopic, minimally invasive colorectal surgery.

BACKGROUND: Intraoperative ureteral injury, a serious complication of abdominopelvic surgeries, can be avoided through ureter visualization. Near-infrared fluorescence imaging offers real-time anatomical visualization of ureters during surgery. Pudexacianinium (ASP5354) chloride is an indocyanine green derivative under investigation for intraoperative ureter visualization during colorectal or gynecologic surgery in adult and pediatric patients. METHODS: In this phase 2 study (NCT04238481), adults undergoing laparoscopic colorectal surgery were randomized to receive one intravenous dose of pudexacianinium 0.3 mg, 1.0 mg, or 3.0 mg. The primary endpoint was successful intraoperative ureter visualization, defined as observation of ureter fluorescence 30 min after pudexacianinium administration and at end of surgery. Safety and pharmacokinetics were also assessed. RESULTS: Participants received pudexacianinium 0.3 mg (n = 3), 1.0 mg (n = 6), or 3.0 mg (n = 3). Most participants were female (n = 10; 83.3%); median age was 54 years (range 24-69) and median BMI was 29.3 kg/m2 (range 18.7-38.1). Successful intraoperative ureter visualization occurred in 2/3, 5/6, and 3/3 participants who received pudexacianinium 0.3 mg, 1.0 mg, or 3.0 mg, respectively. Median intensity values per surgeon assessment were 1 (mild) with the 0.3-mg dose, 2 (moderate) with the 1.0-mg dose, and 3 (strong) with the 3.0-mg dose. A correlation was observed between qualitative (surgeon's recognition/identification of the ureter during surgery) and quantitative (video recordings of the surgeries after study completion) assessment of fluorescence intensity. Two participants experienced serious adverse events, none of which were drug-related toxicities. One adverse event (grade 1 proteinuria) was related to pudexacianinium. Plasma pudexacianinium concentrations were dose-dependent and the mean (± SD) percent excreted into urine during surgery was 22.3% ± 8.0% (0.3-mg dose), 15.6% ± 10.0% (1.0-mg dose), and 39.5% ± 12.4% (3.0-mg dose). CONCLUSIONS: In this study, 1.0 and 3.0 mg pudexacianinium provided ureteral visualization for the duration of minimally invasive, laparoscopic colorectal procedures and was safe and well tolerated.

Effect of bladder emptying status on the ureteral access sheath insertion resistance and following ureteral injury in RIRS: a prospective randomized controlled trial in academic hospital.

PURPOSE: To evaluate the effect of bladder emptying status on the ureteral access sheath (UAS) insertion resistance and following ureteral injury. METHODS: Eighty patients were enrolled and randomly divided into bladder emptying group and control group before UAS placement. A digital force gauge (Imada Z2-50N) was used to measure the resistance during the UAS insertion. The ureteral injury was evaluated and graded with Post-Ureteroscopic Lesion Scale (PULS) system at the end of procedure. The mean resistance, maximum resistance in different ureteral segments, and ureteral injury were compared between the two groups. RESULTS: The mean resistance (3.12 ± 0.49 vs. 4.28 ± 0.52 N, P < 0.001), maximum resistance in the whole procedure (5.17 ± 0.72 vs. 6.39 ± 0.96 N, P < 0.001) and distal ureter (3.07 ± 0.75 vs. 6.18 ± 1.17 N, P < 0.001) in the bladder emptying group were significantly lower when compared to the control group. In subgroup analysis, the similar result was also noted in patients with BMI ≥ 25 when compared to patients with BMI < 25, while there was no significant difference between men and women, age ≥ 50 years versus age < 50 years. The incidence of PULS 1-2 ureteral injury in the bladder emptying group was lower than the control group (35% vs. 55%, P = 0.045). The ureteral injury in distal ureteral was less frequently noted in bladder emptying group than the control group (22.5% vs. 55%, P = 0.006); however, there was no significant difference in middle and upper ureter (P > 0.05). CONCLUSION: Emptying the bladder before UAS insertion can effectively reduce the UAS insertion resistance and the risk of distal ureteral injury in RIRS.