Peritoneal Bacterial Contamination With Closed or Open Rectal Stump
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- The number of Colony-Forming Units (CFU)/ml from the peritoneal samples
研究概览
简要总结
The purpose of this study is to check if there is a difference in peritoneal contamination in patients undergoing rectal resection with closed and open rectal stump prior to anastomosing.
详细描述
There is not much information regarding the peritoneal bacterial contamination during colorectal surgery. The null hypothesis is that there is no difference in peritoneal contamination following resection with closed or open rectal stump for left-sided cancer. Patients scheduled for elective resection are allocated for open resection with the distal stump closed or open. Anastomosis is performed while a clamp is placed on the rectal stump in one arm of the study while in the other arm, the stump remains open until the anastomosis is completed. A second bacterial sample will be obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one. After sampling an air leak test will be performed. A quantitative assessment of the number of Colony Forming Units (CFU/ml) of aerobic and anaerobic bacteria will be done for each patient. Operative time and time interval between samples will be measured. Postoperatively, possible complications (surgical site infections, leakage) will be monitored. The primary objective will be to determine the differences in peritoneal contamination between closed and open rectal stump during colorectal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Care Provider)
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
- •Consecutive adult patients scheduled for a left colectomy, sigmoidectomy or rectal resection with a proposed anastomosis at the level of the rectum agreeing to participate in the study.
排除标准
- •Patients without informed consent
- •Class V patients on American Society of Anesthesiologists (ASA) of Physical Health Score
- •Patient with prior peritonitis
- •Patients with acute inflammatory bowel disease
- •Recent antibiotic treatment
结局指标
主要结局
The number of Colony-Forming Units (CFU)/ml from the peritoneal samples
时间窗: within the first 30 days after surgery
The formula we will use is: number of CFU (colony forming units)/ml = n x 10 x d, where n = number of colonies on the media and d = dilution reverse. The final number of CFU/ml will be given as the arithmetic mean of the three dilutions done for each sample. When no bacterial growth is found the results are given as 0 CFU/ml. The maximum limit is considered 100,000 CFU/ml.
次要结局
未报告次要终点
研究者
Florin Iordache
Senior Lecturer of General Surgery, Attending Surgeon
Bucharest Emergency Hospital
