Acute Urinary Retention After Early, Medium or Late Removal of the Urinary Catheter in Rectal Cancer Surgery. RAOREC Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection.
研究概览
简要总结
DESIGN:
Randomized, open-label and parallel clinical trial, assigned to early, mid, or late withdrawal of urinary catheter with a 1: 1: 1 allocation ratio.
POPULATION:
Patients undergoing anterior rectal resection, low rectal resection, or abdominoperineal amputation for any reason.
OBJECTIVES:
The main objective is to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection.
Secondary objectives are:
- Incidence of urinary tract infection after urinary catheter removal.
- Incidence of specific postoperative complications (Surgical wound infection, Respiratory infection, Anastomotic dehiscence, ileus).
- Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale.
DESCRIPTION OF THE INTERVENTION:
In all patients, a Rectal Resection (anterior rectal resection, posterior pelvic exenteration or abdominoperineal amputation) will be performed. In group 1A, the urinary catheter will be removed on the 1st postoperative day. In group 1B patients, the urinary catheter will be removed on the 3rd postoperative day. In group 1C patients, the urinary catheter will be removed on the 5th postoperative day. All patients will have a urine culture taken at the time of withdrawal.
详细描述
Currently there is a trend towards prolonged urinary catheterization in patients undergoing rectal resection surgery. However, there are studies that defend although there is a slight increase in AUR in these patients, it can be withdrawn early in a safe way with a lower incidence of UTI.
The aim of the study is to analyse whether there are differences in the incidence of AUR in rectal surgery patients and to observe whether it has an impact on other postoperative complications. A randomized clinical trial is proposed to compare an early, mid or late removal of the urinary catheter in patients with rectal resection.
- Potential Risks and Benefits:
Both techniques, both early and late withdrawal, are approved practices that are carried out in a standardized way in the current practice. There are no potential risks associated with the study intervention, beyond the intrinsic risks of the procedure itself.
- Objectives of the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing programmed rectal surgery.
- •Age ≥ 18 years and <85 years.
- •Any type of tumor, any T, N, M.
- •Consent signed by the patient and the researcher.
排除标准
- •IPSS> 20
- •Transanal local resection.
- •Urinary catheterization in the 7 days prior to surgery.
- •Patients taking treatment for benign prostatic hyperplasia.
- •Urine infection in the month prior to surgery.
- •Patients with chronic kidney failure with Creatinine> 2 mg / dL.
- •Enterovesical fistula.
- •Neurogenic bladder.
- •Patients with a sacral nerve stimulator or artificial sphincter.
- •Inability to read or understand any of the languages of informed consent.
- •Emergency surgery.
- •Psychiatric illnesses, addictions or any disorder that prevents the understanding of informed consent.
研究组 & 干预措施
Early Urinary Catheter Removal
Urinary Catheter will be removed the first postoperative day after rectal resection
干预措施: Removal of Urinary Catheter (Procedure)
Medium Urinary Catheter Removal
Urinary Catheter will be removed the third postoperative day after rectal resection
干预措施: Removal of Urinary Catheter (Procedure)
Late Urinary Catheter Removal
Urinary Catheter will be removed the fifth postoperative day after rectal resection
干预措施: Removal of Urinary Catheter (Procedure)
结局指标
主要结局
to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection.
时间窗: 1-30 days
to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection, measured by the proportion of patients that need to be newly catheterized in the first 30 postoperative days.
次要结局
- Incidence of respiratory infection(1-30 days)
- Incidence of anastomotic dehiscence(1-30 days)
- Incidence of postoperative complications(1-30 days)
- Incidence of ileus(1-30 days)
- Incidence of urinary tract infection after urinary catheter removal.(1-30 days)
- Incidence of surgical wound infection(1-30 days)
研究者
Prof. Jose M Enríquez-Navascués
PhD; Head of service
Hospital Donostia