Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- differences in bladder catheter repositioning within 12 hours after bladder catheter removal
研究概览
简要总结
Patients who undergo anterior vaginal wall plastic surgery and place the bladder catheter during surgery are selected. The purpose of the study is to evaluate the presence of statistically significant differences in bladder catheter repositioning within 12 hours after bladder catheter removal in the group of patients in whom the bladder catheter is removed on postoperative day I or II.
Secondary outcomes include evaluation of the incidence of urinary tract infections, number of hospitalization days and total hospitalization costs for patients undergoing anterior vaginal wall surgery in patients in whom the bladder catheter is removed on postoperative day I or II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years of age or older
- •Patients who are candidates for cystopexy surgery
- •Patients who have consented to the signing of the Informed Consent
排除标准
- •Micturition dysfunction with preoperative bladder stagnation > 200 cc at pessary evaluation
- •History of recurrent cystitis
- •Positive preoperative urine culture
- •Azotemia > 40 mg/dL or creatininemia > 1 mg/dL
- •Not collected signed consent endorsed
- •Diabetes mellitus
- •Contraindications to transurethral bladder catheterization
- •Major protocol violations due to unforeseen intraoperative complications (bladder and/or rectal damage, severe bleeding with need for urinary monitoring)
结局指标
主要结局
differences in bladder catheter repositioning within 12 hours after bladder catheter removal
时间窗: 12 hours
After removal of the bladder catheter, on postoperative day I or II, the appearance of urinary urge will be assessed and, in case of spontaneous urination, the quantity of urine will be measured. In the event that after the waiting time of 6 hours an adequate urination stimulus does not arise, we will proceed with an ultrasound evaluation of bladder stagnation (RV) and the application of the department protocol, as follows: * if the sum of diuresis and RV is between 500 and 1000 cc, extemporaneous catheterization and re-evaluation after 4 hours are indicated * if the sum of diuresis and RV is \> 1000cc, positioning of a bladder catheter and maintenance of the same for 5-7 days with subsequent evaluation is indicated.
次要结局
- incidence of urinary tract infections for patients undergoing cystopexy surgery in patients in whom the bladder catheter is removed on postoperative day I or II.(During hospital stay)
研究者
Stefano Salvatore
Professor
IRCCS San Raffaele