Probiotics Against Pathogenic Bacteria in Advanced ENT-Surgery

• Differences in pathogenic bacteria in the oropharynx [ Time Frame: During hospitalization, anticipated mean time 12 days ] [ Designated as safety issue: No ]
  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
  
  

• White Blood Cell count [ Time Frame: During hospital stay, expected mean LOS 12 days ] [ Designated as safety issue: No ]
  WBC taken pre-op and then on predefined days postoperatively
  
  
• C Reactive Protein [ Time Frame: Throughout the hospital stay, expected mean LOS 12 days ] [ Designated as safety issue: No ]
  CRP taken pre-op and then on predefined days postoperatively
  
  
• Length of Hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2-3 weeks ] [ Designated as safety issue: No ]
  Length of stay is recorded for the Hospital stay, and for those cases that have an extended post-operative period in the ICU, the length of the ICU stay will be recorded
  
  
• Survival [ Time Frame: Six months ] [ Designated as safety issue: No ]
  For participating patients the status of survival or non survival at days 28 and 180 (six months) will be recorded
  
  
• Diarrhoea and obstipation [ Time Frame: Throughout the hospital stay, expected mean LOS 12 days ] [ Designated as safety issue: No ]

  As ICU patients tend to display diarrhoea as well as obstipation the frequency and consistency of stools will be recorded.

  Probiotics are anticipated to stabilise bowel function

  
  

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.

Many of the patients will have a tracheostomy performed as part of the surgical procedure.

Patients will be randomised (1:1) to either no prophylaxis (standard procedure today) or to preparation with a probiotic suspension fro the day before surgery until discharge from hospital.

Preoperatively the patients will gurgle a suspension of probiotics and then swallow the preparation.

Postoperatively the probiotics is given enterally and a eventually when the responsible surgeon find it suitable by mouth again.

Cultures at inclusion, after intubation, and then on predefined days postoperatively to compare bacterial flora in the oropharynx and in tracheal secretions.

Infectious parameters will be followed.