Complex lower urinary tract injury resulting from hysterectomy is a rare but highly morbid complication. Although intraoperative recognition reduces the risk of serious sequelae, observational studies have shown that most complex lower urinary tract injuries are recognized in the postoperative period. To date, limited research exists describing the timing of diagnosis of complex lower urinary tract injury or risk factors associated with complex lower urinary tract injury diagnosed in the postoperative period.
This analysis aimed to describe the time to diagnosis of complex lower urinary tract injury among women undergoing benign hysterectomy. We also aimed to identify the intraoperative risk factors for differences in type and timing of complex lower urinary tract injury in the 30-day postoperative period using a large prospective national surgical database.
This was a retrospective analysis using the National Surgical Quality Improvement Program hysterectomy data set from 2014 to 2018. All benign hysterectomies were included. Sociodemographic factors, health status, surgeon type, and other operative characteristics were extracted. A complex lower urinary tract injury was defined as at least 1 ureteral obstruction, ureteral fistula, or bladder fistula diagnosed within the first 30 days following surgery. Bivariate and multivariate logistic regression and cox proportional hazards assessed differences in odds of and time until diagnosis of complex lower urinary tract injury. Proportional hazard assumptions were evaluated with martingale residuals and supremum tests. Significance thresholds were 0.05 for all analyses.
In this study, 100,823 women met the inclusion criteria. Median time to diagnosis of complex lower urinary tract injury was 10 days (interquartile range, 3–19) and varied significantly based on type of injury ( P <.01) with ureteral obstruction (6; interquartile range, 2–16) recognized earlier than ureteral fistula (12; interquartile range, 7–21) and bladder fistula (14; interquartile range, 4–23). In addition, 8.65% of complex lower urinary tract injury were diagnosed on the day of surgery. Total laparoscopic hysterectomy had the lowest rate of complex lower urinary tract injury in unadjusted and adjusted analysis, with abdominal hysterectomy (adjusted odds ratio, 2.02; 95% confidence interval, 1.21–3.36) and vaginal hysterectomy (adjusted odds ratio, 2.05; 95% confidence interval, 1.16–3.62) having greater odds of ureteral obstruction, whereas laparoscopic assisted vaginal hysterectomy had the greatest odds of fistula (adjusted odds ratio, 2.10; 95% confidence interval, 1.26–3.48). Concomitant apical suspension was associated with a 6-day reduction in median time to diagnosis ( P =.01), and surgery with a gynecologic oncologist was associated with a 9.5-day increase in median time to diagnosis ( P =.01). Cox proportional hazards analysis confirmed these findings when controlling for confounders.
Greater than 91% of complex lower urinary tract injury diagnoses in the National Surgical Quality Improvement Program hysterectomy database were diagnosed after the day of surgery. Route of hysterectomy, concomitant apical suspension, and primary surgeon specialty are associated with differences in both type of injury and time until diagnosis. These intraoperative risk factors should be considered when assessing for complex lower urinary tract injury in the 30-day postoperative period.
Lower urinary tract injury (LUTI) at the time of hysterectomy is a rare but highly morbid complication. Multiple risk factors for LUTI at the time of hysterectomy have been identified, including route of surgery, indication for hysterectomy, increased blood loss, concomitant surgical procedures, and surgical technique. Moreover, immediate intraoperative identification and treatment are associated with improved clinical outcomes and decreased litigation. However, observational studies have shown that 54% to 86% of injuries are recognized in the postoperative period.
Why was this study conducted?
Complex lower urinary tract injury (cLUTI) following hysterectomy is a rare but potentially devastating complication. The objective of this study was to describe the timing of diagnosis of cLUTI following hysterectomy and identify risk factors for differences in rate, type, and timing of cLUTI.
We found that surgical approach, surgeon specialty, and performance of concomitant apical suspension procedure were independent risk factors for differences not only in the rate of cLUTI but also in the timing of diagnosis of cLUTI in the postoperative period.
What does this add to what is known?
This study identifies additional risk factors for different timing of cLUTI in the postoperative period and helps clinicians with both intraoperative planning and risk stratification of patients presenting with possible postoperative complications.
Postoperative diagnosis of LUTI often results from 2 sources: failure to recognize injury at the time of hysterectomy or a delayed mechanism of injury. Although sharp genitourinary injury or complete ureteral transection can be diagnosed at the time of surgery, LUTI from thermal injury is more insidious. Undiagnosed injuries are associated with greater risk of serious sequelae, such as bladder and ureteral fistulae, renal failure, infection, and death. , ,
Limited research exists describing risk factors specific to delayed diagnosis of LUTI and temporal trends regarding the interval between surgery and diagnosis. The objective of this study was to describe the type of and time until diagnosis of LUTI in the 30-day postoperative period using a large prospective national surgical database; we also aimed to identify factors associated with differences in these outcomes.
This was a secondary analysis of the 2014 to 2018 National Surgical Quality Improvement Program (NSQIP) hysterectomy target files. The American College of Surgeons (ACS) NSQIP database is a prospective surgical registry that hospitals use to track their risk-adjusted outcomes after surgery. Hospital participation is voluntary and not designed or stratified to be a representative sampling. Data collected include preoperative characteristics and health status, intraoperative events and outcomes, and postoperative outcomes for 30 days following the incident surgery. Data entry is periodically audited to ensure accuracy and quality of the data.
Since 2014, the ACS has maintained a hysterectomy target file with additional information regarding patient and surgeon characteristics of interest, such as parity, surgeon specialty, or history of abdominal surgery. All women from the hysterectomy target file were included in this analysis; individuals with a gynecologic malignancy were excluded.
Demographic and patient-related preoperative variables extracted included age, race and ethnicity, body mass index, baseline functional status, the American Society of Anesthesiologists classification, smoking within the previous year, hypertension requiring medication, diabetes mellitus requiring insulin or oral therapy, parity, history of previous abdominal surgery, and history of previous pelvic surgery. Major medical comorbidities were categorized into cardiac, pulmonary, and neurologic categories. Major cardiac comorbidities include congestive heart failure with exacerbation within 1 month of surgery, myocardial infarction within 6 months of surgery, history of peripheral vascular disease requiring treatment, history of percutaneous coronary intervention, and previous cardiac surgery. Major pulmonary comorbidities include history of severe chronic obstructive pulmonary disease. Major neurologic comorbidities were defined as a history of stroke with or without residual neurologic deficit or history of transient ischemic attack. Definitions were drawn from the NSQIP participant use file and coded as yes, no, or unknown.
Operative characteristics extracted included surgeon specialty, history or intraoperative evidence of endometriosis, and surgical approach to hysterectomy, as defined by the current procedural terminology (CPT) code ( Supplemental Table ). Individuals with concomitant cystoscopy at the time of hysterectomy and concomitant apical suspension were also identified using CPT coding.
LUTI is identified in the hysterectomy target file by the following classification: ureteral obstruction, ureteral fistula, or bladder fistula per NSQIP coding guidelines. We report these as complex LUTI (cLUTI) for the remainder of the document as these data exclude simple cystotomy, which is the most common form of LUTI diagnosed at the time of surgery. The presence of these injuries and the number of days from surgery to diagnosis were extracted. For the purposes of this study, “delayed diagnosis” was defined as diagnosis at any time following the day of surgery. Our primary outcome was the presence of any cLUTI, defined as presence of at least 1 of the above injuries. We also performed a subgroup analysis to assess risk factors specific to ureteral obstruction or LUT fistula, defined as presence of ureteral or bladder fistula. Of note, the subgroup analysis outcomes were not mutually exclusive, and when multiple injuries were present, the shortest time to diagnosis was utilized in the combined cLUTI measure. Patients with missing uterine weight data (4.4%) were excluded from multivariable analysis.
Descriptive analysis was performed for each of the variables and comparisons made for all intraoperative characteristics between individuals with and without cLUTI and time until cLUTI. These analyses were performed using Kruskal-Wallis, Pearson χ 2 , or Fisher exact tests where appropriate. To better assess differences in time to diagnosis of cLUTI, we generated, Kaplan-Meier curves for each variable with a significant relationship to cLUTI on bivariate analysis. Individuals without a cLUTI were assumed to have complete data and were censored at 31 days. Violations of proportional hazards among groups were assessed visually and with log-rank tests.
Next, multivariable logistic regression was used to assess for independent relationships between intraoperative factors and the odds of any cLUTI. Nonhomogeneity between ureteral obstruction and LUT fistula was confirmed and subgroup multivariable analysis performed. Cox proportional hazards analysis was utilized to assess for differences in time until recognition of injury, controlling for demographic and other intraoperative factors. Proportional hazards assumptions of the model were tested using cumulative martingale residuals and the supremum test. If the supremum test was significant, an interaction term between days from surgery and the variable of interest was included in the model to assess for a significant temporal trend.
Given there may be unobserved factors affecting likelihood of cLUTI diagnosis on the day of surgery or during initial hospitalization, a second set of sensitivity analyses were performed using only those individuals with a delayed cLUTI, defined as ≥1 day from surgery to diagnosis as defined by the NSQIP, to confirm the findings of the logistic regression models. All analyses were performed using SAS (version 4.6; SAS Institute, Cary, NC). The study was determined to be institutional review board (IRB) exempt, as reviewed by the Northwestern University IRB (STU00212227).
In this study, 100,823 women in the 2014 to 2018 NSQIP hysterectomy target files met the inclusion criteria. Most women were white (58%) and functionally independent (99%), with low rates of medical comorbidities ( Table 1 ). More than half of the women had previous pelvic surgery (55.8%), and 13.4% of the women had a postoperative diagnosis of endometriosis; only 20.3% of the women had concomitant cystoscopy coded at the time of hysterectomy. The mode of hysterectomy differed by surgeon specialty ( P <.01). Gynecologic oncologists were more likely to perform cases via total abdominal hysterectomy (TAH) (34.6%) or total laparoscopic hysterectomy (TLH) (55.6%), whereas urogynecologists were more likely to perform a total vaginal hysterectomy (TVH) (52.5%). Obstetrician-gynecologists were the primary surgeon in 72.5% of cases and had proportional utilization of all forms of hysterectomy except for laparoscopic assisted vaginal hysterectomy (LAVH), where they performed a disproportionally high number (85.2%) of all cases. Intraoperative characteristics are presented in Table 2 , stratified by injury type.
|Variable||Total sample||cLUTI||P value|
|Age, y (SD)||48.19 (11.00)||47.13 (9.34)||.16|
|BMI, kg/m 2 (SD)||30.94 (7.70)||30.56 (7.79)||.47|
|None||92,693 (91.94)||192 (92.31)||—|
|Noninsulin dependent||5997 (5.95)||10 (4.81)||—|
|Insulin dependent||2133 (2.12)||6 (2.88)||—|
|Race and ethnicity||.08|
|White||58,749 (58.27)||107 (51.44)||—|
|Black||17,422 (17.28)||47 (22.60)||—|
|Hispanic||9065 (8.99)||14 (6.73)||—|
|Asian||3218 (3.19)||8 (3.85)||—|
|Other or unknown||12,369 (12.27)||32 (15.38)||—|
|ASA classification a||.84|
|1||10,185 (10.11)||25 (12.02)||—|
|2||66,585 (66.08)||131 (62.98)||—|
|3||23,283 (23.11)||51 (24.52)||—|
|4||709 (0.70)||1 (0.48)||—|
|Hypertension requiring medication||27,425 (27.20)||54 (25.96)||.68|
|Smoking in the 30 d before surgery||15,233 (15.11)||33 (15.87)||.76|
|Functional status b||.1|
|Independent||100,440 (99.62)||206 (99.04)||—|
|Partially dependent||209 (0.21)||2 (0.96)||—|
|Major medical comorbidity||—|
|Cardiac||90 (0.09)||1 (0.48)||.05|
|Pulmonary||959 (0.95)||5 (2.40)||.03|
|Infectious||521 (0.52)||2 (0.96)||.37|
|Nulliparous c||20,601 (20.43)||49 (23.56)||.26|
|Prior pelvic surgery||56,604 (56.14)||124 (59.62)||.31|
|Prior abdominal surgery||27,145 (26.92)||64 (30.77)||.21|
|2014||13,521 (13.41)||27 (12.98)||—|
|2015||16,292 (16.16)||39 (18.75)||—|
|2016||20,589 (20.42)||45 (21.63)||—|
|2017||22,789 (22.60)||45 (21.63)||—|
|2018||27,632 (27.41)||52 (25)||—|
|Variable||cLUTI||Ureteral obstruction||LUT fistula|
|30-day incidence||P value||Days to diagnosis||P value||30-day incidence||P value||Days to diagnosis||P value||30-day incidence||P value||Days to diagnosis||P value|
|Total||208 (0.206)||—||—||—||111 (0.110)||—||—||—||105 (0.104)||—||—||—|
|Surgeon specialty||—||.276||—||.086||—||.03 b||—||.049 b||—||.391||—||.477|
|Gynecologic oncology||26 (0.141)||—||16.5 (5–24)||—||12 (0.065)||—||16.5 (3.0–25.5)||—||14 (0.076)||—||16.5 (6.0–23.0)||—|
|Generalist||163 (0.223)||—||7.0 (2.0–16.0)||—||86 (0.118)||—||3.5 (2.0–11.0)||—||84 (0.115)||—||13.5 (5.0–22.0)||—|
|Urogynecologist||18 (0.224)||—||6.0 (1.0–19.0)||—||13 (0.162)||—||7.0 (1.0–19.0)||—||6 (0.075)||—||9.5 (5.0–11.0)||—|
|Other a||1 (0.078)||—||4||—||0 (0.000)||—||—||—||1 (0.078)||—||4||—|
|Method of hysterectomy||—||.032 b||—||.014 b||—||.003 b||—||.381||—||.001 b||—||.457|
|TLH||78 (0.165)||—||8.5 (3.0–15.0)||—||37 (0.078)||—||7.0 (1.0–14.0)||—||44 (0.093)||—||11.0 (4.5–20.5)||—|
|LAVH||34 (0.264)||—||14.0 (5.0–21.0)||—||10 (0.078)||—||11.0 (4.0–16.0)||—||26 (0.202)||—||15.5 (8.0–23.0)||—|
|TAH||63 (0.255)||—||6.0 (2.0–20.0)||—||39 (0.158)||—||3.0 (2.0–11.0)||—||25 (0.101)||—||18.0 (5.0–22.0)||—|
|TVH||33 (0.206)||—||3.0 (1.0–11.0)||—||25 (0.156)||—||3.0 (1.0–8.0)||—||10 (0.062)||—||12.5 (1.0–22.0)||—|
|Uterine weight (g)||—||.365||—||.230||—||.578||—||.853||—||.779||—||.211|
|<100||57 (0.183)||—||7.0 (2.0–20.0)||—||31 (0.099)||—||6.0 (1.0–16.0)||—||28 (0.090)||—||10.5 (4.0–23.5)||—|
|100–249||83 (0.213)||—||10.0 (2.0–16.0)||—||44 (0.113)||—||5.0 (1.5–13.5)||—||43 (0.110)||—||14.0 (6.0–21.0)||—|
|250–499||26 (0.191)||—||14.0 (4.0–22.0)||—||13 (0.095)||—||5.0 (2.0–14.0)||—||14 (0.103)||—||21.0 (12.0–24.0)||—|
|≥500||33 (0.265)||—||5.0 (2.0–14.0)||—||18 (0.145)||—||2.5 (2.0–10.0)||—||15 (0.120)||—||11.0 (4.0–15.0)||—|
|Diagnosis of endometriosis||—||<.001 b||—||.827||—||<.001 b||—||.502||—||.043 b||—||—|
|No||161 (0.184)||—||8.0 (2.0–18.0)||—||82 (0.094)||—||4.0 (2.0–11.0)||—||84 (0.096)||—||13.0 (5.0–22.0)||—|
|Yes||47 (0.350)||—||7.0 (2.0–23.0)||—||29 (0.216)||—||7.0 (1.0–16.0)||—||21 (0.157)||—||14.0 (5.0–23.0)||—|
|Concomitant apical suspension||—||.068||—||.011 b||—||<.001 b||—||.655||—||.37||—||.085|
|No||184 (0.198)||—||9.0 (3.0–20.0)||—||91 (0.098)||—||5.0 (2.0–13.0)||—||99 (0.107)||—||14.0 (5.0–22.0)||—|
|Yes||24 (0.293)||—||3.0 (0.5–12.5)||—||20 (0.245)||—||4.5 (1.0–11.5)||—||6 (0.073)||—||4.5 (1.0–11.0)||—|