Abdominopelvic Surgery: Intraoperative Ureteral Injury and Prophylaxis in the United States, 2015–2019

McCarus, Steven D; Alexandre, Ana Filipa; Kimura, Tomomi; Feng, Qi; Han, Wei; Shortridge, Emily; Lima, Robson Barbosa; Schwartz, J.Stanford; Wexner, Steven D.

doi:10.1007/s12325-023-02515-z

Cited by 10 publications

(6 citation statements)

References 22 publications

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“…Any potential risk is further mitigated by the administration of pudexacianinium solely within the confines of a surgical suite/operating room, an environment well-equipped to monitor and treat hypersensitivity reactions in the unlikely event they might occur. Published rates of IUI varied by surgery type and may be higher than previously reported [3]. Image-guided surgery using NIR-F imaging is a promising technique that offers real-time visualization for surgeons, helping minimize the risk for IUI and potentially leading to better overall patient outcomes.…”

Section: Discussionmentioning

confidence: 94%

“…Results of a 10-year (2001-2010) retrospective analysis of ureteral injury in colorectal surgery showed that 6027 (0.28%) cases had been identified in approximately 2 million procedures performed in the United States [2]. More recent results of a retrospective cohort study of approximately 2.5 million abdominopelvic surgeries in the United States (2015)(2016)(2017)(2018)(2019) showed that rates of IUI varied by surgery type and were higher than previously reported [3]. Overall, IUIs occurred in 0.88% (95% confidence interval [CI] 0.86-0.90) 1 3 of gastrointestinal surgeries, 0.29% (95% CI 0.28-0.30) of gynecological surgeries, and 1.17% (95% CI 1.08-1.26) of other abdominopelvic surgeries.…”

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confidence: 95%

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

et al. 2023

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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.

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Section: Discussionmentioning

confidence: 94%

mentioning

confidence: 95%

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

et al. 2023

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“…Iatrogenic ureteral injury is rare but difficult to manage [ 1 ]. The frequency of operative ureteral injury after abdominopelvic surgery varies depending on the series studied [ 1 ]; McCarus et al reported an incidence of 1% in 2.5 million abdominopelvic surgeries in the United States [ 2 ]. The retroperitoneal location of the ureter, combined with its close contact with abdominal and pelvic structures, can make it difficult to identify intraoperatively, leaving it vulnerable to accidental injury (ligation, coagulation, devascularisation) [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

“…The retroperitoneal location of the ureter, combined with its close contact with abdominal and pelvic structures, can make it difficult to identify intraoperatively, leaving it vulnerable to accidental injury (ligation, coagulation, devascularisation) [ 3 ]. The consequences of these injuries are serious, including urinary obstruction or fistula, infectious complications, renal failure and even death [ 2 ]. In addition, such lesions can have a significant economic impact by increasing the length of hospitalisation and the cost of subsequent treatment.…”

Section: Introductionmentioning

confidence: 99%

“…Thus, it seems essential for any surgeon to know the interventions at risk of intraoperative ureteral lesion to insist on preventive measures such as urinary tract drainage in certain cases, which has been reported to significantly reduce the incidence of ureteral injuries and good intraoperative exposure [ 2 ]. It is also important for all surgeons to be aware of the consequences of a peroperative lesion of the ureter and its associated morbidity, as well as the consequences of such a complication.…”

Section: Introductionmentioning

confidence: 99%

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Management strategies and root causes of missed iatrogenic intraoperative ureteral injuries with delayed diagnosis: a retrospective cohort study of 40 cases

Zaghbib¹,

Saadi²,

Boussaffa³

et al. 2023

Patient Saf Surg

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Background Intraoperative iatrogenic ureteral injuries represent rare technical surgical complications with the potential for adverse patient outcomes, particularly when the diagnosis is delayed. Ideally, these technical complications are recognized and repaired intraoperatively. This study was designed to investigate the root causes and outcomes of missed intraoperative ureteral injuries at a tertiary urology referral centre in Tunisia. Methods This is a retrospective cohort study in a tertiary urology referral centre in Tunis from January 1st, 2015, to December 31st, 2020, including all patients with iatrogenic ureteral injury, not diagnosed intraoperatively. The factors associated with the success of endoscopic treatment and those associated with the unfavourable evolution were investigated. Results A total of 40 iatrogenic ureteral injuries were included. Gynaecological surgery was responsible for 85% of ureteral injuries, mainly during hysterectomies (55%). The symptoms were dominated by low back pain (37.5%) and pyelonephritis (25%). Endoscopic treatment was attempted in 22 cases, it was sufficient in 12 cases. Ureteral injury required surgical treatment in 24 cases, and ureteroneocystostomy was performed in 16 cases. Nephrectomy was performed in eight cases, representing 20% of injuries, including three cases as the first treatment for late-diagnosed cases with a destroyed kidney. In the analytical study, endoscopic treatment was sufficient in 50% in case of ureteral fistula versus 27% in case of ureteral stenosis (p = 0.04). Nephrectomy was performed in 10% of cases when ureteral injury was diagnosed within the first month postoperatively compared to 60% of cases when this delay exceeded one month (p = 0.004). Conclusion Iatrogenic ureteral injuries discovered postoperatively are mostly secondary to gynaecologic surgery. Although endoscopic treatment is usually performed as a first treatment, a more aggressive surgical is often necessary, with a nephrectomy rate of 20%.

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Iatrogenic urinary injuries in colorectal surgery: outcomes and risk factors from a nationwide cohort

McClelland,

Liu,

Johnson

et al. 2024

Tech Coloproctol

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Abdominopelvic Surgery: Intraoperative Ureteral Injury and Prophylaxis in the United States, 2015–2019

Cited by 10 publications

References 22 publications

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

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

Management strategies and root causes of missed iatrogenic intraoperative ureteral injuries with delayed diagnosis: a retrospective cohort study of 40 cases

Iatrogenic urinary injuries in colorectal surgery: outcomes and risk factors from a nationwide cohort

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