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临床试验/NCT03663504
NCT03663504进行中(未招募)4 期

A Randomised Study Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery (REaCT-NSQIP)

Ottawa Hospital Research Institute13 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2018年10月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
630
试验地点
13
主要终点
Post-Operative Surgical Infection Complication

研究概览

简要总结

The REaCT NSQIP will compare oral antibiotics vs. no antibiotics, which are two standards of care treatments for preoperative preparation of the bowel prior to colorectal surgery

详细描述

The divergence of clinical practice guidelines, in addition to observation from the large North American retrospective studies, suggest that surgeons and centers have not established a standard of care for the preoperative preparation of the bowel prior to colorectal surgery. Specifically, some centers are employing no preparation, others are administering a mechanical bowel preparation (MBP) and oral antibiotics and still others are using oral antibiotics alone. Recently, the Canadian Society of Colorectal Surgeons was unable to come to a consensus when attempting to update their preoperative guidelines because of the lack of agreement on best practice (personal communication). This is an important yet controversial topic in colorectal surgery and a clinical trial comparing two standard of care therapies will impact current practice in Canada. The REaCT-NSQIP study compares post-operative surgical infectious complications, length of stay, incidence of C. difficile rates, patient quality of life and cost-effectiveness in patients undergoing elective colorectal surgery with either no preparation or oral antibiotics. Data will be collected from the National Surgical Quality Improvement Program (NSQIP) and from patient quality of life questionnaires preoperatively and 30 days postoperatively

In this study, it is hypothesized that it is the oral antibiotics, and not the MBP, that is responsible for the reduction in postoperative infectious surgical complications (deep or superficial surgical site infection (SSI)) in patients undergoing elective colorectal resections. This improvement in postoperative infectious complications is not anticipated to result in a clinically significant increase in postoperative C. difficile infections or antibiotic resistant hospital-acquired infections.

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

入选标准

  • Patients undergoing elective, non-emergency colon, resection surgery or abdominal perineal resection and no other requirements exists for a mechanical bowel preparation (as determined by the operating surgeon)
  • 18 years of age or older
  • Able to provide oral consent

排除标准

  • Contraindication to the oral antibiotics, including allergies or adverse reactions to either metronidazole or neomycin
  • Undergoing a rectal resection with a planned anastomosis (these patients will all receive MBP)
  • Emergency surgery where no opportunity to administer preoperative oral antibiotics exists
  • Requirement for a MBP (i.e. rectal resection with pelvic anastomosis, intraoperative colonoscopy, or at the discretion of the treating surgeon

研究组 & 干预措施

No Preparation

Active Comparator

No preparation before surgery

干预措施: No Preparation (Other)

Oral Antibiotics

Active Comparator

Oral antibiotics (neomycin and flagyl), to be taken the day before the surgery

干预措施: Neomycin and Flagyl (Drug)

结局指标

主要结局

Post-Operative Surgical Infection Complication

时间窗: 30 days

To evaluate that use of oral antibiotics (neomycin and flagyl), administered the day prior to elective colonic resection is associated with a significant reduction in postoperative (within 30 days) surgical infectious complications (superficial and deep space infections).

次要结局

  • Grade III-IV Postoperative Surgical Site Infectious Complication(30 days)
  • Postoperative Infections Complications(30 days)
  • Overall Postoperative Complication Rate(30 days)
  • Postoperative Length of Stay(Number of days spent in hospital post-operatively, average of 6 days)
  • Incidence of Postoperative C. difficile Infections(90 days)
  • Incidence of Antibiotics Resistant Postoperative Infectious Complications(30 days)
  • Patient Quality of Life(30 days)
  • Direct Estimation of Health Utility Values(30 days)
  • Incremental Cost-Effectiveness Ratio(Through to study completion, an average of 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (13)

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