NCT02922647已完成不适用
Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年10月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Number of participants with urinary tract infection when using suprapubic versus transurethral catheterization as assessed by significant bacteriuria and pyuria
研究概览
简要总结
The purpose of this study is to compare the urinary tract infection rate on the four postoperative day between the 2 groups of patients who have undergone total mesorectal excision for cancer and low anastomosis, with either suprapubic or transurethral catheterization.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients of at least 18 years of age
- •Histologically proven rectal adenocarcinoma
- •Stage T1-4 Nx Mx
- •With or without neoadjuvant treatment
- •TME and low anastomosis (colorectal or coloanal, stapled or handsewn)
- •With or without loop ileostomy
- •Open or laparoscopic approach
- •Patient and doctor have signed a study specific informed consent form
排除标准
- •Colonic and upper third rectal cancer (No or Partial Mesorectal Excision)
- •Abdominoperineal resection
- •Associated prostate, and/or seminal glands and/or bladder resection
- •Infected tumour, Emergency surgery
- •Epidural analgesia
- •Patient with antibiotic therapy (other than prophylaxis)
- •Previous treated/untreated known prostate or bladder carcinoma
- •Patient with symptomatic preoperative voiding dysfunction (IPSS score >19)
- •Medical history of bladder catheterization for obstruction, or urethral surgery
- •Patient necessitating urinary output monitoring (impaired renal function etc)
- •Patient deprived of liberty or under guardianship or incapable of giving consent
- •Against the usual indications of suprapubic drainage and / or urethral sounding any known allergies to medical device materials. (p. ex. latex) and in general the known allergies to sterilizing agents (particularly oxide ethylene and its derivatives.
结局指标
主要结局
Number of participants with urinary tract infection when using suprapubic versus transurethral catheterization as assessed by significant bacteriuria and pyuria
时间窗: four days postoperative
The urinary tract infection, defined as significant bacteriuria ( \> 104 CFU / mL) and pyuria (\> 6 white blood cells per high power field) in urine samples obtained immediately after removal of the urethral catheter or clamping suprapubic catheter and removing the fourth postoperative day.
次要结局
- Duration of catherism as assessed by the number of days for participants with the catheter and number of participants leaving the hospital with the catheter(1 month)
- Participants morbidity and mortality as assessed by Dindo and Clavien classification(at 1 month and 6 months)
- Cost as assessed by the addition of the costs of the full process depending on the catheterism duration and additional consultations and readmissions for complications(at 6 months)
- Specific complications(in the first 6 months)
- Pain as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra(at 1, 2, 3 and 4 days)
- Duration of postoperative return to normal bladder function as assessed by IPSS score(at 1 and 6 months)
- Number of additionnal consultations(in the first 6 months)
- Rate of satisfaction for participants as assessed by questionnaries (Fact-C and EQ-5D-3L(at 30 days and 6 months)
- Duration of hospital stay in days(within 6 months)
- Rate of recatheterization(in the first 6 months)
- Lack of comfort as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra(at 1, 2, 3 and 4 days)
研究者
研究点 (2)
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