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临床试验/NCT02527382
NCT02527382已完成不适用

Peritoneal Bacterial Contamination With Closed or Open Rectal Stump

Florin Iordache0 个研究点目标入组 26 人开始时间: 2014年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Florin Iordache

Senior Lecturer of General Surgery, Attending Surgeon

Bucharest Emergency Hospital

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