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临床试验/NCT01154530
NCT01154530已完成不适用

Chlorhexidine Mouthwash and Bacterial Contamination During Endoscopy. Implementation of Chlorhexidine Mouthwash Before Transgastric NOTES

Herlev Hospital2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2011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
102
试验地点
2
主要终点
Quantification of culture samples

研究概览

简要总结

Background:

Natural Orifice Transluminal Endoscopic Surgery (NOTES) is a surgical technique that has been rapidly evolving over the last five years. The technique probably has a great potential in surgical gastroenterology, urology and gynaecology.

The technique is based on the idea of minimally invasive surgery. The human organism is affected by a stress response when exposed to surgery. This stress response can be minimized by reducing the size of the openings whereby the surgeon gains access to the organs. This affects how quickly a patient recovers after surgery and can be discharged and resumes daily life and work. The same principal have been responsible for the surgical evolution in the last 15-20 years where many procedures have gone from traditional open operations with large incisions in the abdominal wall to laparoscopic surgery with cameras through small holes in the abdominal wall.

The latest addition to minimal invasive surgery is NOTES. Here the surgeon gains access to the abdominal organs with flexible endoscopes through the body's natural openings i.e. the mouth and stomach. With this technique the surgeon avoids cutting through skin and muscle of the abdominal wall, thus minimizing the surgical stress response. This minimizes postoperative pain, the incidence of incisional hernias, eliminates wound infection, and properly prevents scar tissue formation inside the abdominal cavity which way lead to ileus. The end result is a quicker discharge and a better cosmetic result.

It has been shown in numerous animal studies that NOTES is feasible and in recent years a rapidly increasing number of published patient series.

However, there is a risk of infection associated with accessing the abdominal cavity through a natural body opening, which initially is unclean and can not be disinfected in the same way as the skin of the abdominal wall.

Numerous microbiological pig studies have shown that there is transfer of bacteria from the body opening (i.e. mouth) to the abdominal cavity when performing NOTES, but this contamination have no correlation to infection after surgery, neither in terms of healing or survival.

It is unclear from the literature whether patients should be offered proton pump inhibitor (PPI) therapy to reduce the acidity of the stomach before NOTES interventions. The rationale has been that such a treatment can make the gastric juices less acidic and thereby reduce the incidence of chemical peritonitis, which can occur when acidic juices flows from the stomach and into the abdominal cavity. It is known however that the acidic environment of the stomach provides a natural barrier for bacteria. Making the gastric juices less acidic could potentially increase the risk of bacterial peritonitis.

It is known that the bacterial content of the stomach is low due the acidic environment but bacteria passed down from the mouth and throat with the endoscope could potentially result in bacterial peritonitis.

That bacteria from the throat can lead to infections due to instrumentation is known from intensive care units. Ventilated patients may risk getting pneumonia with bacteria from the throat. Several studies have shown that using mouthwash with a chlorhexidine solution can reduce the risk of ventilator associated pneumonia.

Hypothesis:

Mouthwash with 2 cl 0,2% chlorhexidine solution before a gastroscopy reduces the bacterial content in cultures taken from the stomach and the endoscope after a gastroscopy.

Simultaneous PPI treatment gives higher bacterial counts in the cultures.

详细描述

Background:

Natural Orifice Transluminal Endoscopic Surgery (NOTES) is a surgical technique that has been rapidly evolving over the last five years. The technique probably has a great potential in surgical gastroenterology, urology and gynaecology.

The technique is based on the idea of minimally invasive surgery. The human organism is affected by a stress response when exposed to surgery. This stress response can be minimized by reducing the size of the openings whereby the surgeon gains access to the organs. This affects how quickly a patient recovers after surgery and can be discharged and resumes daily life and work. The same principal have been responsible for the surgical evolution in the last 15-20 years where many procedures have gone from traditional open operations with large incisions in the abdominal wall to laparoscopic surgery with cameras through small holes in the abdominal wall.

The latest addition to minimal invasive surgery is NOTES. Here the surgeon gains access to the abdominal organs with flexible endoscopes through the body's natural openings i.e. the mouth and stomach. With this technique the surgeon avoids cutting through skin and muscle of the abdominal wall, thus minimizing the surgical stress response. This minimizes postoperative pain, the incidence of incisional hernias, eliminates wound infection, and properly prevents scar tissue formation inside the abdominal cavity which way lead to ileus. The end result is a quicker discharge and a better cosmetic result.

It has been shown in numerous animal studies that NOTES is feasible and in recent years a rapidly increasing number of published patient series.

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

  • Adult men and women over 18 years referred to gastroscopy in an outpatient setting.
  • Danish speaking.
  • Written informed consent after verbal and written information.

排除标准

  • Feeding tube, or the use of a gastric or duodenal tube in the week prior to inclusion.
  • Gastroscopy in the week prior to inclusion.
  • Removable prosthetic teeth.
  • Use of antiseptic mouthwash in the week prior to inclusion.
  • Gastroenteroanastomosis.
  • Gastrocystotomy.
  • Stents in oesophagus / stomach / duodenum / pancreatic or hepatic ducts.
  • Known cancer in esophagus / stomach / duodenum / pancreas.
  • Percutaneous Endoscopic Gastrostomy / Percutaneous Ultrasonic Gastrostomy
  • Known infection or in antibiotic treatment.
  • Pregnant or breastfeeding.

结局指标

主要结局

Quantification of culture samples

时间窗: 1 week

Bacterial count in the culture samples. Quantified with colony forming units (CFU).

次要结局

  • Bacteria species(1 week)
  • The influence of PPI treatment on bacterial count(1 week)

研究者

申办方类型
Other

研究点 (2)

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