Intraoperative Cystoscopic Evaluation of Ureteral Patency: A Randomized Controlled Trial
| Autor: | Alexandriah Alas, Eric A. Hurtado, Sneha Vaish, Lauren N. Siff, G Willy Davila, Sami A Chadi, Matthew D. Barber, Luis M Espaillat-Rijo Md, Stephen Zimberg |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Phenazopyridine genetic structures Attitude of Health Personnel medicine.medical_treatment Operative Time Administration Oral law.invention 03 medical and health sciences 0302 clinical medicine Gynecologic Surgical Procedures Randomized controlled trial law medicine Humans 030212 general & internal medicine Prospective Studies Intraoperative Complications Saline Pelvic surgery Aged Fluorescent Dyes 030219 obstetrics & reproductive medicine Intraoperative Care medicine.diagnostic_test business.industry Obstetrics and Gynecology Cystoscopy Middle Aged Urinary Retention Surgery Glucose Urinary Tract Infections Wounds and Injuries Administration Intravenous Female Fluorescein Ureter business Ureteral Obstruction |
| Zdroj: | Obstetrics and gynecology. 128(6) |
| ISSN: | 1873-233X |
| Popis: | To compare different modalities to aid in the evaluation of intraoperative ureteral patency on cystoscopy in the postindigo carmine era.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.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.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.ClinicalTrials.gov, https://clinicaltrials.gov, NCT02476448. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|