Female pelvic medicine & reconstructive surgery · 2020
Indwelling Versus Immediate Removal of Transurethral Catheter After Robotic Sacrocolpopexy: A Randomized Clinical Trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Vallabh-Patel Vaneesha, Popiel Patrick, Salamon Charbel
Аннотация
INTRODUCTION AND HYPOTHESIS: This study evaluates the necessity and effect of an indwelling transurethral catheter in the early postoperative period following a robotic-assisted laparoscopic sacrocolpopexy.
METHODS: This was a randomized clinical trial of patients who underwent a robotic sacrocolpopexy for pelvic organ prolapse. Patients were randomized to have their transurethral catheter removed 6 hours postoperative (intervention group) or the morning following surgery (control group). Our primary outcome was to compare the number of patients diagnosed with postoperative incomplete bladder empyting in each group. A sample size of 36 patients per group was needed to detect a 25% difference between the 2 groups. Anticipating a 20% patient withdrawal rate, we estimated that we would need a total of 88 participants. Outcome variable was analyzed using χ test, Fisher exact test, Mann-Whitney U test, 2-proportions test, and 2-sample t test.
RESULTS: From December 2015 through May 2017, 88 women were randomized and analyzed: 44 in the intervention group and 44 in the control group. Women in the intervention group were more likely to be diagnosed with incomplete bladder emptying, 14 (31%) of 44, compared with the control group, 2 (4.5%) of 44, P <0.001. Rate of urinary tract infections within the 30-day postoperative period was also increased in the intervention group, 4 (9%) of 44, compared with 0 in the control group. Postoperative complications were similar between groups.
CONCLUSIONS: In women undergoing a robotic sacrocolpopexy, early transurethral catheter removal (6 hours postoperative) is associated with an increased rate of incomplete bladder emptying, recatheterization, and urinary tract infections.
METHODS: This was a randomized clinical trial of patients who underwent a robotic sacrocolpopexy for pelvic organ prolapse. Patients were randomized to have their transurethral catheter removed 6 hours postoperative (intervention group) or the morning following surgery (control group). Our primary outcome was to compare the number of patients diagnosed with postoperative incomplete bladder empyting in each group. A sample size of 36 patients per group was needed to detect a 25% difference between the 2 groups. Anticipating a 20% patient withdrawal rate, we estimated that we would need a total of 88 participants. Outcome variable was analyzed using χ test, Fisher exact test, Mann-Whitney U test, 2-proportions test, and 2-sample t test.
RESULTS: From December 2015 through May 2017, 88 women were randomized and analyzed: 44 in the intervention group and 44 in the control group. Women in the intervention group were more likely to be diagnosed with incomplete bladder emptying, 14 (31%) of 44, compared with the control group, 2 (4.5%) of 44, P <0.001. Rate of urinary tract infections within the 30-day postoperative period was also increased in the intervention group, 4 (9%) of 44, compared with 0 in the control group. Postoperative complications were similar between groups.
CONCLUSIONS: In women undergoing a robotic sacrocolpopexy, early transurethral catheter removal (6 hours postoperative) is associated with an increased rate of incomplete bladder emptying, recatheterization, and urinary tract infections.