Intraoperative Cystoscopic Evaluation of Ureteral Patency: A Randomized Controlled Trial.

OBJECTIVE: To compare different modalities to aid in the evaluation of intraoperative ureteral patency on cystoscopy in the postindigo carmine era. METHODS: In a randomized controlled trial, participants undergoing pelvic surgery were randomized into one of four groups: saline distention (control), 10% dextrose distention, oral phenazopyridine, or intravenous sodium fluorescein. Our primary outcome was visibility of the ureteral jets. Secondary outcomes included surgeon satisfaction; adverse reactions including allergies, urinary tract infections, urinary retention, cystoscopy times, and ureteral obstruction; and delayed diagnosis. Participants were followed for 6 weeks. A sample size of 176 participants was planned to demonstrate a 30% difference in the visibility scale. All analyses were performed in an intention-to-treat fashion. RESULTS: From February 25, 2015, through August 2015, 176 participants were enrolled; 174 completed the trial, and two did not undergo intervention. Forty-four participants were included in the phenazopyridine, dextrose, saline, and sodium fluorescein groups. Sodium fluorescein and 10% dextrose resulted in significantly improved visibility and satisfaction when compared with the control group (P<.001 and P=.004, respectively). Dextrose provided the highest satisfaction and phenazopyridine provided lowest, but visibility was not statistically different between the two groups (P=.101). Three ureteral obstructions were identified intraoperatively and none in the postoperative period. Mean total cystoscopy time varied between 4.0 and 4.8 minutes and postoperative urinary retention rate was 50% across all groups. Overall urinary tract infection rate was 24.1%, which was similar between interventions. There were no related adverse events. CONCLUSION: Compared with the control, 10% dextrose and sodium fluorescein resulted in improved visibility and provided significantly more satisfaction in the evaluation for ureteral patency with no considerable increase in operative time or morbidity. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02476448.

Operating room fatigue: is your twentieth surgical knot as strong as your first?

OBJECTIVE: This study aimed to determine the tensile strength in a series of 20 consecutively tied knots. Knot tying is a universally used technique in surgical procedures, and as such, knot integrity and security are essential. STUDY DESIGN: Twenty was the number of knots chosen as this is the average number of knots required for a vaginal hysterectomy. We used 0-0 gauge, nonexpired, polyglactin 910 to tie 20 knots in succession with less than 20 seconds rest between knots. The knots were tied without a surgeon's knot and 4 additional square knots (1 = 1 = 1 = 1 = 1). The knots were tied by 2 obstetrician/gynecologists investigators over the period of 2 weeks to minimize fatigue. The sutures were then soaked in 0.9% sodium chloride for 60 seconds and subsequently transferred to a Chatillon LTCM-100 tensiometer (Ametek, Largo, Florida) where the tails were cut to 3 mm length. The force required to break the knots was recorded. To detect a difference over time while maintaining power of 80% with a type I error rate of 5%, a minimum of 17 series of knots were needed (thus, 340 total knots after tying 20 knots per series). To buffer against unanticipated variability in the tensile strengths over time, we rounded the number of knot series up to 20, so a total of 400 knots were tied. RESULTS: A total of 800 knots were tied. All the sutures broke at the knot and 36% untied. For analyses, the data for each series of knots were collapsed into quarters (ie, knots 1-5, 6-10, 11-15, and 16-20). A repeated-measures analysis of variance found that there were no statistically significant differences between the four quartiles (p = 0.87). A paired samples t-test comparing the first knots in each series with the last knots in each series showed no difference (p = 0.99). Similarly, a paired samples t-test comparing the first 10 knots to the last 10 knots showed no difference over time (p = 0.8). To determine whether there was a change in likelihood of knots coming untied, as more knots were tied, Cochran's Q was used to look across the entire series of 20 knots. This analysis of proportions coming untied revealed no differences over time (p = 0.61). To compare across quarters, a Friedman test was used and similarly showed no change over time (p = 0.92). The different investigators were controlled for in the analysis as a covariate, which turned out to be statistically significant, p = 0.003. CONCLUSIONS: Under laboratory conditions, the order of knots tied does not change the tensile strength of the material. This would infer that fatigue does not influence the tensile strength for a series of 20 knots; however, additional studies with a larger number of knots series may be warranted.

Outcome measures and definition of cure in female stress urinary incontinence surgery: a survey of recent publications.

INTRODUCTION AND HYPOTHESIS: Much variability exists in outcome measures used to report success of SUI surgery. We set out to evaluate outcome measures and definitions of cure in SUI surgery studies. METHODS: Outcome measures, success rates, and definition of cure were analyzed from published series and compared to recommendations by leading authorities. RESULTS: Ninety-one publications were analyzed. Thirty (33%) utilized solely subjective measures, four (4%) utilized only objective measures, and 57 (63%) included both. Sixty-one (67%) used symptom questionnaires, 56 (60%) QOL questionnaires, and six (7%) visual analog scale. Twelve (13%) used voiding diaries and 52 (56%) used self-reporting as an outcome measure. Objective measures: 52 (57%) cough stress test, 37 (41%) urodynamic evaluation, 28 (31%) pad testing and a combination in 33 (36%). Few studies adhered to one set of outcome recommendations. CONCLUSION: Outcome measures used to evaluate success of anti-incontinence procedures lack consensus and comparability.