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临床试验/NCT01730066
NCT01730066已完成不适用

Probiotics for Reduction of Pathogenic Bacteria in Connection With Advanced Surgery in the Mouth, the Oropharynx, and on the Neck

Region Skane2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
45
试验地点
2
主要终点
Differences in pathogenic bacteria in the oropharynx

研究概览

简要总结

Surgery in the mouth and oropharynx is performed in an area colonised by bacteria non-pathogenic and pathogenic.

Antibiotics are used regularly resulting in disturbances in the intestinal microbiological flora and consequently diarrhoea that can be troublesome. The use of antibiotics throughout the hospital stay for these difficult cases represent a risk of development of resistant strains.

Most of the patients have cancer diagnoses and have radiation therapy before surgery. This increases the risk of the patients having pathogenic bacteria normally present in the lower GI-tract.

The investigators have shown for ICU patients that treatment with probiotics reduces the number of emerging enteral bacteria in the oropharynx and now the investigators will perform an adjusted procedure for patients planned for large ear, nose, and throat (ENT) surgery.

Patients will preoperatively gurgle a suspension of probiotics and then swallow the preparation.

Postoperatively the probiotics is given enterally and a eventually by mouth again.

Cultures will be taken from the oropharynx and tracheal secretions and the results will be compared

详细描述

Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx.

Surgery including the mouth and the oropharynx is performed in an area that is colonised by hundreds of different bacterial species. In the healthy person there is a balance between the different microbes and possible pathogens are kept under control.

Patients that are subject to surgery in the mouth, oropharynx or neck area, most often have cancer diagnoses. Preoperative treatment (mostly radiation) is done in most cases resulting in a changed spectrum of bacteria in the mouth and oropharynx. Due to lowered appetite increased difficulties to eat, in combination with cancer diagnosis, there is also a change in cranial direction of the microbiological gut flora resulting in the presence of pathogens such as Gram-negative bacteria. Those species may result in troublesome infections in the postoperative period.

With healthy people pathogenic bacteria originating from the gastro/intestinal canal are seldom found in the oropharynx, but those do occur among many patients.

Antibiotics are used prophylactic and for more extensive surgery, as micro vascular procedures with free transplants of tissues, antibiotics are kept throughout the length of stay (LOS) in hospital. This results in an increased risk for the development of resistant bacteria and does result in changes in the GI flora in those patients. Diarrhoea occurs frequently and are troublesome for the patients For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this study will explore the possibility of the same kind of positive effects in patients due for extensive surgery performed during several hours.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective advanced and extensive ENT surgery
  • Adult patients (≥ 18 years)
  • Surgery requires general anesthesia and endotracheal intubation
  • Length of anesthesia ≥ 1,5 hours
  • Signed informed consent

排除标准

  • Ongoing treatment requiring infection in the lower respiratory tract
  • Chronic lung disease requiring oxygen treatment
  • Known immune deficiency

结局指标

主要结局

Differences in pathogenic bacteria in the oropharynx

时间窗: During hospitalization, anticipated mean time 12 days

Emerging and resident bacteria will be compared for the cultures taken in the oropharynx and from tracheal secretions in connection to a surgical intervention and postoperatively

次要结局

  • Length of Hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 2-3 weeks)
  • Diarrhoea and obstipation(Throughout the hospital stay, expected mean LOS 12 days)
  • C Reactive Protein(Throughout the hospital stay, expected mean LOS 12 days)
  • White Blood Cell count(During hospital stay, expected mean LOS 12 days)
  • Survival(Six months)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (2)

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