Prospective Randomized Controlled Trial of Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Post-operative urinary retention requiring re-catheterisation
研究概览
简要总结
Patients undergoing colon or rectal surgery will usually have a urinary catheter (silicone tube) placed in the bladder at the time of operating to monitor kidney function during surgery and in the post-surgery period. Such patients will also have an infusion into the spine, known as an epidural, after surgery to provide them with continuous pain relief. Urinary catheters should be removed as early as possible once they are no longer required to facilitate patients becoming mobile after surgery and to reduce the risk of patients developing a urinary tract infection.
Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.
详细描述
Patients undergoing colon or rectal surgery will be randomly assigned to one of two groups: Patients in study group 1 (SG1) will have their urinary catheters removed at 48 hours post-operatively; Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period. We will be primarily examining rates of urinary retention in both groups. We will also be examining rates of urinary tract infection, chest infection (frequently a result of poor mobility after surgery), and wound infection and other complications after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age > 18
- •Competent to consent to participate in trial
- •Undergoing colorectal surgery (any resection of large bowel, formation of colostomy, anterior resection, low anterior resection, panproctocolectomy, abdominoperineal resection).
- •Receiving epidural analgesia post-operatively
- •If male, international prostate symptom score <20.
排除标准
- •Previous lower urinary tract surgery
- •Chronic lower urinary tract disease
- •Intermittent self-catheterisation
- •Neurogenic bladder
- •Urethral catheter inserted >24 hours pre-operatively
- •Presence of pelvic sepsis/abscess at surgery
- •Previous trans-abdominal pelvic surgery
- •Urethral catheter required for urine output monitoring beyond 24 hours post-operatively
- •Presence of enterovesical fistula
- •Pre-operative use of medications which alter detrusor function
- •Pregnancy
研究组 & 干预措施
Study group 1
Early removal of urethral catheter 48 hours post-operatively.
干预措施: Removal of urethral catheter (Other)
Study group 2
Removal of urethral catheter once epidural analgesia has been withdrawn.
干预措施: Removal of urethral catheter (Other)
结局指标
主要结局
Post-operative urinary retention requiring re-catheterisation
时间窗: 14 days following urethral catheter removal
Development of acute post-operative urinary retention demonstrated by a post-void residual \>100mls on bladder ultrasound requiring re-catheterisation within 2 weeks of removal of urethral catheter in the post-operative period.
次要结局
- Symptomatic bacteruria(Within 14 days of urethral catheter removal)
- Surgical site infection(Within 7 days post-operatively)
- Pulmonary complications(For the first 14 days post-operatively)
研究者
Myles Joyce
Consultant colorectal and general surgeon
University College Hospital Galway