Grimes Cara L, Patankar Sonali, Ryntz Timothy, Philip Nisha, Simpson Khara, Truong Mireille, Young Constance, Advincula Arnold, Madueke-Laveaux Obianuju S, Walters Ryan, Ananth Cande V, Kim Jin Hee
Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY.
Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY.
Am J Obstet Gynecol. 2017 Nov;217(5):601.e1-601.e10. doi: 10.1016/j.ajog.2017.07.012. Epub 2017 Jul 18.
Many gynecologic, urologic, and pelvic reconstructive surgeries require accurate intraoperative evaluation of ureteral patency.
We performed a randomized controlled trial to compare surgeon satisfaction with 4 methods of evaluating ureteral patency during cystoscopy at the time of benign gynecologic or pelvic reconstructive surgery: oral phenazopyridine, intravenous sodium fluorescein, mannitol bladder distention, and normal saline bladder distention.
We conducted an unblinded randomized controlled trial of the method used to evaluate ureteral patency during cystoscopy at time of benign gynecologic or pelvic reconstructive surgery. Subjects were randomized to receive 200 mg oral phenazopyridine, 25 mg intravenous sodium fluorescein, mannitol bladder distention, or normal saline bladder distention during cystoscopy. The primary outcome was surgeon satisfaction with the method, assessed via a 100-mm visual analog scale with 0 indicating strong agreement and 100 indicating strong disagreement with the statement. Secondary outcomes included comparing visual analog scale responses about ease of each method and visualization of ureteral jets, bladder mucosa and urethra, and operative information, including time to surgeon confidence in the ureteral jets. Adverse events were evaluated for at least 6 weeks after the surgical procedure, and through the end of the study. All statistical analyses were based on the intent-to-treat principle, and comparisons were 2-tailed.
In all, 130 subjects were randomized to phenazopyridine (n = 33), sodium fluorescein (n = 32), mannitol (n = 32), or normal saline (n = 33). At randomization, patient characteristics were similar across groups. With regard to the primary outcome, mannitol was the method that physicians found most satisfactory on a visual analog scale. The median (range) scores for physicians assessing ureteral patency were 48 (0-83), 20 (0-82), 0 (0-44), and 23 (3-96) mm for phenazopyridine, sodium fluorescein, mannitol, and normal saline, respectively (P < .001). Surgery length, cystoscopy length, and time to surgeon confidence in visualization of ureteral jets were not different across the 4 randomized groups. During the 189-day follow-up, no differences in adverse events were seen among the groups, including urinary tract infections.
The use of mannitol during cystoscopy to assess ureteral patency provided surgeons with the most overall satisfaction, ease of use, and superior visualization without affecting surgery or cystoscopy times. There were no differences in adverse events, including incidence of urinary tract infections.
许多妇科、泌尿科和盆腔重建手术需要在术中准确评估输尿管通畅情况。
我们进行了一项随机对照试验，比较在良性妇科或盆腔重建手术中，外科医生对膀胱镜检查时评估输尿管通畅的4种方法的满意度：口服非那吡啶、静脉注射荧光素钠、甘露醇膀胱充盈和生理盐水膀胱充盈。
我们对在良性妇科或盆腔重建手术中膀胱镜检查时评估输尿管通畅的方法进行了一项非盲随机对照试验。受试者被随机分为在膀胱镜检查时接受200毫克口服非那吡啶、25毫克静脉注射荧光素钠、甘露醇膀胱充盈或生理盐水膀胱充盈。主要结局是外科医生对该方法的满意度，通过100毫米视觉模拟量表进行评估，0表示强烈同意，100表示强烈不同意该陈述。次要结局包括比较视觉模拟量表对每种方法的易用性以及输尿管喷尿、膀胱黏膜和尿道可视化的反应，以及手术信息，包括外科医生对输尿管喷尿有信心所需的时间。在手术后至少6周以及研究结束时评估不良事件。所有统计分析均基于意向性治疗原则，比较采用双侧检验。
总共130名受试者被随机分为非那吡啶组（n = 33）、荧光素钠组（n = 32）、甘露醇组（n = 32）或生理盐水组（n = 33）。随机分组时，各组患者特征相似。关于主要结局，在视觉模拟量表上，甘露醇是医生认为最满意的方法。评估输尿管通畅情况的医生的中位数（范围）得分，非那吡啶组为48（0 - 83）毫米，荧光素钠组为20（0 - 82）毫米，甘露醇组为0（0 - 44）毫米，生理盐水组为23（3 - 96）毫米（P <.001）。4个随机分组的手术时长、膀胱镜检查时长以及外科医生对输尿管喷尿可视化有信心所需的时间没有差异。在189天的随访期间，各组不良事件无差异，包括尿路感染。
膀胱镜检查时使用甘露醇评估输尿管通畅情况，能为外科医生提供最高的总体满意度、易用性和更好的可视化效果，且不影响手术或膀胱镜检查时间。不良事件无差异，包括尿路感染的发生率。
