Int Urogynecol J DOI 10.1007/s00192-015-2770-1

ORIGINAL ARTICLE

Risk factors for ureteral occlusion during transvaginal uterosacral ligament suspension Elisha Jackson 2 & Jorge A. Bilbao 2 & Robert W. Vera 1 & Zuber D. Mulla 2 & Veronica T. Mallett 1 & T. Ignacio Montoya 1

Received: 2 April 2015 / Accepted: 18 June 2015 # The International Urogynecological Association 2015

Abstract Introduction and hypothesis To determine any risk factors associated with ureteral occlusion during transvaginal uterosacral ligament suspension (USLS). Methods A retrospective query to identify patients that underwent transvaginal USLS at a teaching hospital from 2008 to 2013 was performed. Patients in which ureteral occlusion was identified by cystoscopy were identified (cases), and compared with those without occlusion (controls). Medical records were reviewed for data abstraction. Variables compared between cases and controls included demographics, medical history/examination, concomitant procedures, number of suspension sutures placed, estimated blood loss and length of hospital stay. Univariate analyses were performed to identify potential risk factors for ureteral occlusion, followed by multivariate regression analysis to estimate odds ratios for identified predictors. Results A total of 144 USLS procedures were performed. Thirteen cases of ureteral occlusion were identified (9%). Baseline prolapse stage, body mass index, parity, previous hysterectomy or pelvic surgery of the groups were similar (all P>0.05). Univariate analysis identified age (P=0.04), concomitant anterior colporrhaphy (P=0.01), and use of a Presented at the 41st Annual Scientific Meeting of the Society of Gynecologic Surgeons, Orlando, FL, 22–25 March 2015 * T. Ignacio Montoya [email protected] 1

Division of Female Pelvic Medicine and Reconstructive Surgery, Texas Tech University Health Sciences Center El Paso, 4800 Alberta Avenue, El Paso, TX 79905, USA

2

Department of Obstetrics and Gynecology, Texas Tech University Health Sciences Center at El Paso, El Paso, TX, USA

suture-capturing device for suture placement (P=0.04) as significant factors. On multivariate logistic regression analysis, concomitant anterior colporrhaphy increased ureteral occlusion risk (OR 10.5, 95%CI 2.37–74.99, P=0.001), while use of a suture-capturing device decreased it (OR 0.1, 95%CI 0– 0.41, P = 0.01). The mean number of suspension sutures placed per side was similar in the two groups (2.6 [range 2– 4] for cases and 2.4 [range 1–4] for controls, P=0.15). Conclusions During transvaginal USLS, performance of a concomitant anterior colporrhaphy increased the risk of ureteral occlusion, while the use of a suture-capturing device for suspension suture placement was associated with decreased risk. Key words Ureteral injury . Uterosacral ligament suspension . Vaginal prolapse surgery

Introduction Uterosacral ligament suspension (USLS) is a commonly performed procedure used to correct prolapse of the vaginal apex. The procedure consists of approximating the vaginal apex to the uterosacral ligaments with a series of sutures placed bilaterally, and is most often performed from a transvaginal approach [1, 2]. USLS is associated with favorable outcomes and is overall safe [1–6]. However, given the anatomical proximity of the uterosacral ligaments to the ureters, ureteral injury during suspension suture placement may occur [7, 8]. Ureteral occlusion in this setting occurs as a result of partial or complete ligation, kinking or anatomical distortion by the nearby sutures [9]. The reported rates for this complication found in the literature range from less than 1 % [4] to 11 % [2]. Longterm sequelae from unidentified ureteral obstruction may be associated with high morbidity and include pain, fistula

Int Urogynecol J

formation, and dilation of the urinary collecting system, leading to loss of renal parenchyma and renal failure [10]. In addition, urinary tract injury associated with gynecological surgery often leads to medicolegal action [11]. As a measure for avoiding these undesired sequelae, cystoscopy is usually performed after suspension suture placement during USLS to ensure visualization of bilateral ureteral flow [12, 13]. Any interruption of ureteral flow is usually addressed by removal of the suspension sutures, ureteral stenting, and, rarely, surgical repair of the ureter if severe injury is sustained [9, 14]. Preventive measures, such as prophylactic ureteral catheter or stent placement during gynecological surgery to enhance ureteral identification, have not been shown to decrease the rate of ureteral injury, and most would not advocate universal implementation of this strategy [15, 16]. Rather, some suggest that selective use of ureteral catheterization may play a role in injury prevention [17, 18]. The identification of patient predictors yielding an increased risk of ureteral occlusion during USLS would provide the operating surgeon with heightened awareness during performance of the procedure, or may be used to guide the selected use of prophylactic ureteral catheterization. Here, we performed a retrospective case/control analysis of transvaginal USLS procedures performed at a single center for the assessment of risk factors for ureteral occlusion.

[19], concomitant procedures performed along with USLS (including hysterectomy, anti-incontinence procedures, anterior and posterior colporrhaphies), history of gynecological cancer, history of endometriosis, history of estrogencontaining hormone therapy use, smoking status, estimated intraoperative blood loss, length of hospital stay, number of suspension sutures placed per side, type of suspension suture material, and use of a suture-capturing device for suspension suture placement (Capio; Boston Scientific, Natick, MA, USA). In addition, for identified cases, procedures performed to resolve ureteral occlusion (including suspension suture release, need for ureteral catheterization and/or stenting, ureteral repair) were recorded. All clinical variables obtained from chart review of the case and control groups were compared using independent parametric and nonparametric tests as appropriate. The association between the occurrence of ureteral occlusion and potential risk factors was analyzed using Fisher’s exact test for contingency tables and by the Chisquare test for trend for tables with ordered categories (univariate analysis). Those variables attaining a significance level of 0.05 or less in the univariate analysis were considered jointly in a multivariate exact logistic regression model, a technique for which no sample size assumption is needed [20]. Data analysis was performed using SAS version 9.2 (SAS Institute, Cary, NC, USA).

Materials and methods

Results

Approval from the Institutional Review Board at Texas Tech University Health Sciences Center at El Paso was obtained. An electronic query was performed to identify all transvaginal USLS procedures performed in women with symptomatic vaginal prolapse by three urogynecology/FPMRS faculty surgeons between 1 January 2008 and 31 December 2013. Two of the three faculty surgeons are fellowship-trained. Transvaginal USLS was performed intraperitoneally following a previously reported technique [1]. Varying numbers of suspension sutures and combinations of suture material were used, depending on faculty surgeon preference. Operative reports and discharge summaries were reviewed individually to identify those subjects in whom intraoperative ureteral occlusion occurred (Bcases^). The remainder of the subjects who underwent transvaginal USLS during the established time period without ureteral occlusion were grouped as Bcontrols.^ The following information was abstracted from preoperative documentation and preoperative clinic visits for all case and control subjects: age, parity, weight, height, calculated body mass index, previous history of hysterectomy, previous surgery for vaginal prolapse, previous urinary tract surgery (including surgery for urinary incontinence), previous pelvic surgery, preoperative Pelvic Organ Prolapse Quantification (POP-Q) stage of vaginal prolapse at each compartment

A total of 144 transvaginal USLS procedures were performed during the study period. Thirteen cases of ureteral occlusion were identified (9%). Demographic data and univariate analyses for cases and controls are summarized in Table 1. The mean age was 60.1 years (range 50–73) for cases and 54.9 years (range 32–81) for controls. Mean BMI of the two groups was similar, with 29.8 kg/m2 (range 24.6–36.1) for cases and 29.1 kg/m2 (range 18.9–49.6) for controls. There was no difference in case occurrence between operating surgeons (P = 0.21). Patient characteristics of the groups, including parity, history of vaginal prolapse or urinary incontinence procedures, previous hysterectomy, and preoperative use of estrogen, were similar as well (all P>0.05). There were no patients in either group with a documented history of pelvic surgery (other than for vaginal prolapse, urinary incontinence) or history of endometriosis. The distribution of baseline POP-Q stage of the groups was similar, with 77 % of cases and 68 % of controls having stage 2 or greater apical prolapse, 100 % of cases and 91 % of controls having stage 2 or greater anterior wall prolapse, and 38 % of cases and 46 % of controls having stage 2 or greater posterior wall prolapse. Concomitant hysterectomy was common in both groups, with 92.3 % of cases and 88.6 % of controls undergoing the procedure. Other concomitant

Int Urogynecol J Table 1

Demographics and univariate analysis of cases of ureteral occlusion and controls

Age (years) ≤40 41–59 ≥60 Body mass index (kg/m2) Parity Number of vaginal deliveries Previous hysterectomy History of previous surgery for POP History of previous surgery for SUI History of previous pelvic surgery (other than for POP or SUI) History of endometriosis History of estrogen use History of gynecological cancer History of smoking Baseline anterior wall POP-Q stage 0 1 2 3 4 Baseline apical POP-Q stage 0 1 2 3 4 Baseline posterior wall POP-Q stage 0 1 2 3 4 Faculty surgeon A B C Concomitant Procedures Hysterectomy Left salpingo-oophorectomy Right salpingo-oophorectomy Anterior colporrhaphy Posterior colporrhaphy Midurethral sling Incidental cystotomy Number of suspension sutures

Cases n=13 Number (%) or mean ± SD

Controls n=131 Number (%) or mean ± SD

P*

0 (0) 4 (30.8) 9 (69.2) 29.8±3.4 4.6±2.1 4.5±1.9 1 (7.7) 0 (0)

12 (9.2) 78 (59.5) 41 (31.3) 29.1±5.4a 3.7±1.9b 3.6±1.9b 15 (11.8) 3 (2.4)a

0.63 0.1 0.13 1.0 1.0

0 (0) 0 (0)

0 (0)a 0 (0)a

– –

0 (0) 2 (15.4) 0 (0) 2 (15.4)

0 (0)c 22 (17.2)c 0 (0)c 16 (12.5)c

– 1.0 – 0.67 0.31

0 (0) 0 (0) 6 (46.2) 3 (23.1)

0 (0) 11 (8.7) 59 (46.5) 41 (32.3)

4 (30.8)

16 (12.6)

0 (0) 3 (23.1) 3 (23.1) 2 (15.4) 5 (38.5)

0 (0) 41 (32.3) 52 (40.9) 21 (16.5) 13 (10.2)

0 (0) 8 (61.5) 2 (15.4) 2 (15.4) 1 (7.7)

5 (3.9) 64 (50.4) 44 (34.7) 2 (1.6) 12 (9.5)

1 (7.7) 1 (7.7) 11 (84.6)

33 (25.2) 4 (3.1) 94 (71.8)

12 (92.3) 7 (53.9) 5 (38.5) 11 (84.6) 5 (38.5) 9 (69.2) 0 (0)

116 (88.6) 39 (30) 35 (26.7) 59 (45) 42 (32.1) 94 (71.8) 3 (2.3)

0.04

0.06

0.09

0.21

1.0 0.12 0.35 0.01 0.76 1.0 1.0

Int Urogynecol J Table 1 (continued) Cases n=13 Number (%) or mean ± SD

Controls n=131 Number (%) or mean ± SD

2.6±0.7 2.6±0.7

2.4±0.6 2.4±0.6

11 (84.6) 1 (7.7) 1 (7.7) 0 (0) 247.7±196.4 1.38±0.6

94 (71.7) 3 (2.3) 34 (26) 34 (26) 245.5±156.9d 1.56±0.7

Right Left Suture material Delayed absorbable only Permanent + delayed absorbable Permanent only Suture placement device use for suspension suture placement Estimated blood loss (mL) Length of stay (days)

P*

0.15 0.15 0.15

0.04 0.96 0.39

SD standard deviation, POP pelvic organ prolapse, SUI stress urinary incontinence, POP-Q pelvic organ prolapse quantification staging system *From Fisher’s exact, Chi-square, or Student’s t test as appropriate a

Data available for review n=127

b

n=126

c

n=128

d

n=110

procedures performed, including uni- or bilateral salpingo-oophorectomy, posterior colporrhaphy, and mid-urethral slings, were similar for cases and controls (all P>0.05). The mean number of suspension sutures placed per side was similar in the two groups (2.6 [range 2–4] versus 2.4 [range 1–4] for Bcases^ and Bcontrols^ respectively; P =0.15). There were no differences between the groups in the type of suspension suture material used (delayed absorbable alone; delayed absorbable plus permanent; permanent alone). Intraoperative estimated blood loss was 247.7 ml (range 20–800) for cases and 245.5 ml (range 25–850) for controls. Length of hospital stay was 1.4 days (range 1–3) for cases and 1.6 days (range 1–4) for controls.

Table 2

Results of the exact multiple logistic regression analysis Exact ORa

Age (years) ≤40 2.18b 41–59 1 ≥60 3.57 Concomitant anterior colporrhaphy Yes 10.52 No 1 Use of suture capturing device Yes No

0.1 1

95%CI

P

0–11.35 (Referent) 0.94–15.63

0.70 – 0.06

2.37–74.99 (Referent)

0.001 –

0–0.41 (Referent)

0.01 –

a

Each odds ratio is adjusted for the remaining variables found in the table

b

A median unbiased estimate

Univariate analysis (Table 1) identified age (categorized as ≤40, 41–59, and ≥60, P = 0.04), concomitant anterior colporrhaphy (P=0.01), and the use of a suture-capturing device for suture placement (P=0.04) as factors associated with ureteral occlusion. Exact multiple logistic regression analysis identified two significant predictors (Table 2). Concomitant anterior colporrhaphy was associated with increased risk of ureteral occlusion (OR 10.5, 95%CI 2.37–74.99, P =0.001), while the use of a suture-capturing device for suspension suture placement was associated with decreased risk (OR 0.1, 95%CI 0–0.41, P =0.01). All cases and controls had concomitant cystoscopy performed after placement and tying of suspension sutures through the uterosacral ligaments and the vaginal cuff. All occlusions were identified intraoperatively by cystoscopy. Six occlusions occurred on the left (46%), 6 on the right (46%), and 1 bilaterally (8%). In most cases, reestablishment of ureteral flow was achieved after removal of the most distally placed suture (84%) on the affected side. The rest of the cases (16%) necessitated removal of the two most distally placed sutures. There was no need for any additional procedures to address ureteral injury.

Discussion Ureteral occlusion associated with transvaginal USLS has the potential for severe patient morbidity if not immediately recognized. The ease and availability of cystoscopy enables prompt identification of this complication and resolution is usually achieved with immediate, systematic suspension

Int Urogynecol J

suture removal. In some cases, however, the suspension sutures are not replaced after removal, potentially compromising the optimal procedural outcome. Hence, the identification of patient predictors to minimize the risk of ureteral involvement and impact on procedural efficacy would be desirable. In our study, ureteral occlusion was more frequent in those patients undergoing concomitant anterior colporrhaphy. Ureteral injury is a potential complication of anterior colporrhaphy alone, with reported rates of 2 % [21]. Occlusion in this scenario likely occurs as a result of kinking or entrapment of the ureter during placement of midline plication sutures in the proximal third of the anterior vagina, where the ureteral location may be less than a centimeter away [22]. The risk of ureteral obstruction may be heightened when an Bultra-lateral^ or multi-layered approach is utilized. It is important to note that in our study, none of the occlusions identified required removal of anterior colporrhaphy sutures. All occlusions resolved with removal of at least one of the USLS sutures on the affected side. Alternatively, ureteral occlusion may occur during anchoring of the suspension sutures most distally placed on the ligaments to the corners of the vaginal cuff, where ureters may course at distances as small as 0.1 to 0.5 cm laterally [23]. A concomitant anterior colporrhaphy during transvaginal USLS may pull the ureters toward the midline of the proximal anterior vagina, shortening the distance from the corners of the vaginal cuff and making ureteral compromise more likely. Although formulating a recommendation is outside the scope of this retrospective analysis, selective preoperative ureteral catheterization in patients undergoing transvaginal USLS with concomitant anterior colporrhaphy to facilitate ureteral palpation may play a role in decreasing occlusion rates, especially in a teaching setting. The use of a suture placement device was identified as a protective factor against ureteral occlusion. The operating surgeon was not a significant factor for ureteral occlusion in multivariate analysis, regardless of suture placement device use. It is possible that the use of a suture placement device provides a more constant, predictable path and depth of needle placement. On the other hand, suture placement with a regular needle driver is subject to variability depending on the type of needle used and surgeon technique, with possible differences in depth and travel distance of the needle along the ligament. A dorsal and posterior technique for USL suture placement, advocated as protective for ureteral injury [24], is utilized by all surgeons in this study, with or without use of the suture placement device. Although this study cannot support a recommendation for routine suture placement device use during USLS to decrease the risk of ureteral occlusion, this finding is interesting and further investigation seems to be warranted. The optimal number of suspension sutures to place per side has not been defined, and varied numbers of sutures used reported in the literature seem to have similar outcomes [1, 2, 4, 5]. Most of these studies, however, are small, of

retrospective design, and have short follow-up periods. Cadaveric data suggest that a higher number of sutures correlates with increased strength of repair [25]. Thus, it may be desirable to place a higher number of sutures, when possible, to optimize procedural efficacy and/or longevity. In our analysis, it is reassuring to see that the number of sutures used does not seem to influence occlusion risk. In most cases, ureteral occlusion was resolved by removal of the most distal suspension suture on the affected side. This is consistent with the anatomical relationship between the sites of suture placement along the uterosacral ligament and normal ureteral course, as the most distal suture is associated with the shortest distance to the ureter [7, 25]. Patient demographics, including BMI and age, were not associated with increased risk, suggesting consistency of uterosacral ligament-to-ureter distances regardless of pelvic dimensions and degree of retroperitoneal Bpadding,^ or fat content. Our patient cohort did not have a documented history of endometriosis or previous pelvic surgery, which can be associated with adhesion formation and distortion of the sigmoid colon and other nearby pelvic structures; as such, we cannot comment on the impact of adhesive disease on occlusion risk. Similarly, there was a paucity of patients who underwent USLS as a secondary prolapse repair procedure; thus, we cannot comment on occlusion risk in primary versus repeat procedures. We found a 9 % rate of intraoperatively identified ureteral occlusion, which is toward the upper limits of rates found in the literature [2]. Although lower rates have been reported by other centers [4], our rate is reflective of the study setting, that is, a teaching hospital with OB/GYN resident trainee involvement. It is well recognized that prompt identification and management of urinary tract obstruction completely averts future sequelae [26], making the routine use of cystoscopy after suspension suture placement mandatory. The study has several limitations. First, its retrospective design limits our ability to formulate absolute recommendations based on our findings, which must be interpreted with caution. Data collection from available medical records is subject to inaccuracies and incomplete data entries, which may result in incomplete data abstraction, ultimately compromising the intended data analysis. We utilized an electronic medical record that facilitates complete data collection and only found a few missing data points, which we carefully documented in Table 1. We do not believe that the missing points had a significant impact on our analysis or findings. Next, we did not assess for ureteral obstruction with delayed recognition, potentially underestimating our ureteral occlusion rate. However, delayed recognition of such an injury is an extremely rare occurrence in our practice, given the routine use of cystoscopy at time of USLS. Finally, our methods of data abstraction did not include a practical way of assessing postoperative procedural efficacy, but this is outside the scope

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of the study question. Strengths of our study include review of a moderate number of transvaginal USLS procedures performed by three different urogynecology faculty surgeons, employing different numbers of suspension sutures, needles, and materials, albeit with similar suture placement techniques. Hopefully, these characteristics are reflective of common transvaginal USLS practices and give the findings more generalizability and a wider applicability. Future direction includes a prospective assessment of ureteral occlusion when risk factors are present, evaluation of the utility of ureteral catheterization used selectively in those situations, and further exploration of the possible protective role of a suture placement device. In spite of the study’s limitations, we feel that the study findings provide fresh insight into a relatively common complication for a common procedure, adding to the reconstructive pelvic surgeon’s operative awareness and ever-present quest for optimal procedural performance.

15.

Conflicts of interest None.

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Risk factors for ureteral occlusion during transvaginal uterosacral ligament suspension.

To determine any risk factors associated with ureteral occlusion during transvaginal uterosacral ligament suspension (USLS)...
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