Comparison of Two Bladder Catheterization Strategies in Thoracic Surgery Patients With an Enhanced Recovery After Surgery (ERAS): Systematic Intermittent Catheterization Versus Bladder Scan Guided Catheterization in the Post Anesthesia Care Unit: a Prospective Randomized Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Occurrence of acute urinary retention (AUR) within 24 hours postoperatively
研究概览
简要总结
General anesthesia, thoracic epidural, and morphine inhibit the urination process and promote postoperative Acute Urinary Retention (AUR) after thoracic surgery. Indwelling bladder catheterization prevents this risk, but is associated with other complications (urinary tract infection, delayed mobilization). With the rise of enhanced recovery after surgery (ERAS) protocols, bladder catheterization is being questioned. The current protocol in the department is to catheterize only patients with a high bladder volume in the post anesthesia care unit (defined as a bladder volume > 400 ml on bladder scan). Preliminary results from the "AirLeaks" study show a high rate of early postoperative AUR (approximately 50%). The investigators believe that a "systematic intermittent catheterization" (SIC) strategy is superior to the current "bladder scan-guided catheterization in the post anesthesia care unit" (BSGC) strategy in preventing the risk of postoperative AUR. To their knowledge, no study has compared these two bladder catheterization strategies in a thoracic accelerated rehabilitation protocol.
详细描述
Acute urinary retention (AUR) is clinically defined by the presence of a bladder globe, with complete inability to urinate, sometimes associated with severe suprapubic abdominal pain. It is a urological emergency. An AUR can be complicated by acute renal failure, obstruction lifting syndrome (polyuria), a vacuo hematuria, or a slammed bladder (characterized by the presence of a post-void residue).
Systematic intermittent catheterization (SIC) allows monitoring of diuresis during the per- and post-operative period, and prevents the risk of AUR. It is associated with numerous disadvantages, such as the risk of infection (nosocomial urinary tract infection, bacteriuria, candiduria), which doubles after 2 days of catheterization, the risk of trauma (bleeding from the urethra, hematuria), the delay in mobilization and ambulation, and the psychological impact on the patients (dependence, agitation, confusion). All of these complications are potentially at risk of lengthening the average length of stay, and represent an additional cost for the Health Insurance. Thus, it seems that SIC is an obstacle to enhance recovery after surgery (ERAS), which is why the investigators have eliminated this option in our center. However, even recent American protocols for thoracic ERAS consider that an epidural should be associated with an indwelling catheter.
Bladder catheterization strategies are available for patients undergoing lung surgery. Options include no bladder catheterization, evacuation catheterization, and post anesthesia care unit catheterization guided by ultrasound or bladder scan measurement of bladder volume.
SIC is a strategy that involves draining urine once, in all patients, after surgery (in the operating room). Bladder Scan Guided Catheterization in the post anesthesia care unit (BSGC) is an innovative strategy that consists of a standardized and reproducible assessment of the bladder volume before discharge from the post anesthesia care unit, and draining urine only in patients who require it.
To their knowledge, no study has compared these two bladder catheterization strategies in a thoracic ERAS protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing scheduled thoracic surgery at the study center
- •Be of legal age
- •Be eligible for the enhanced recovery after surgery (ERAS) protocol in effect in the department.
排除标准
- •Non-intubated anesthesia with spontaneous ventilation (NIVATS)
- •Already have an indwelling bladder catheter or suprapubic catheter or double J catheter or other urinary drainage device
- •Urinary tract infection under treatment or bladder catheterization less than one month old
- •Indication of per- or postoperative bladder catheterization for another reason (e.g. monitoring of diuresis in chronic renal failure)
- •Known vesico-sphincter disorder with documented post-void residue
- •Neurological bladder (spinal cord injury or stroke sequelae)
- •Documented urinary incontinence
- •Chronic renal failure with a glomerular filtration rate (GFR) < 30 ml/min
- •Contraindication to bladder catheterization (e.g. stenosis of the urethra)
- •Be under legal protection or incapable of giving consent
- •Failure to obtain written informed consent after a reflection period
- •Not be affiliated to a French social security system or a beneficiary of such a system
- •Long-term morphine drugs
- •Pregnancy in progress or planned during the study period, Pregnant or nursing women
研究组 & 干预措施
Systematic Intermittent Catheterization (SIC)
A bladder catheter will be placed in the operating room, at the end of the operation, in a patient still under general anesthesia. Once the urine has been drained and quantified, the bladder catheter will be removed before the patient is discharged and extubated.
干预措施: Systematic Intermittent Catheterization (Procedure)
Bladder Scan Guided Catheterization (BSGC)
No systematic catheterization will be performed, the indication for catheterization will be guided by bladder-scan volume monitoring.
干预措施: Bladder Scan Guided Catheterization (Procedure)
结局指标
主要结局
Occurrence of acute urinary retention (AUR) within 24 hours postoperatively
时间窗: 24 hours after thoracic surgery
AUR is defined by the absence of voiding recovery in an unprobed patient, with or without pubic pain (pain may be inhibited by epidural or morphine received), associated with a bladder volume \> 400 ml on bladder scan.
次要结局
- Bladder volume drained(The first hour after catheter placement)
- Length of hospital stay(During the 5 days of post-surgical hospitalization)
- Occurrence of acute urinary retention (AUR) after Day 1 and during the first 5 days after surgery or during the hospital stay(Between Day 1 and Day 5 postoperative)
- Total duration of the first bladder catheterization(During the first bladder catheterization)
- Total number of bladder catheterizations(During the 5 days of post-surgical hospitalization)
- Other postoperative complications(During the 5 days of post-surgical hospitalization)
- The rate of complications related to AUR(During the 5 days of post-surgical hospitalization)
- Duration before putting in the chair (in hours)(During the 5 days of post-surgical hospitalization)
- Duration before standing up (in hours)(During the 5 days of post-surgical hospitalization)
- Estimated cost of stay(During the 5 days of post-surgical hospitalization)
- The rate of complications related to catheterization(During the 5 days of post-surgical hospitalization)