Chlorhexidine Mouthwash and Bacterial Contamination During Endoscopy

This study has been completed.
Sponsor:
Collaborators:
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01154530
First received: June 29, 2010
Last updated: August 16, 2011
Last verified: December 2010

June 29, 2010
August 16, 2011
January 2011
August 2011   (final data collection date for primary outcome measure)
Quantification of culture samples [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Bacterial count in the culture samples. Quantified with colony forming units (CFU).
Same as current
Complete list of historical versions of study NCT01154530 on ClinicalTrials.gov Archive Site
  • The influence of PPI treatment on bacterial count [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    To study whether ongoing PPI treatment gives higher bacterial counts in the culture samples
  • Bacteria species [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Classification of bacteria species in the culture samples
Same as current
Not Provided
Not Provided
 
Chlorhexidine Mouthwash and Bacterial Contamination During Endoscopy
Chlorhexidine Mouthwash and Bacterial Contamination During Endoscopy. Implementation of Chlorhexidine Mouthwash Before Transgastric NOTES

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.

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.

Trial Participants:

Trial Participants will be recruited among patients referred to gastroscopy in an outpatient setting, at Herlev, Gentofte and Bispebjerg Hospital.

Participants must be over 18 years old regardless of gender. The participants are included after oral and written information about the trial and with written consent. The request for participation and written information about the trial is send to the patient by conventional mail. The oral information is given on the day of the gastroscopy. Inclusion in the trial has no consequences for the purpose of the gastroscopy, or on any further diagnostic procedures or treatments. Trial Participants may at any time withdraw from the trial without consequences.

Method:

Included participants are randomized by drawing a random envelope with a continuous registration number containing information on whether the patient is allocated to the intervention or control group.

Enclosed in the envelope is a registration form where the following is recorded: sex, age, weight, height, indication for gastroscopy, number of instrumentations during gastroscopy, the use of rinse and suction, and PPI treatment.

Participants in the intervention group perform a mouthwash with 2 cl 0,2% chlorhexidine for 30 seconds immediately before the gastroscopy.

Participants in the control group perform no mouthwash before the gastroscopy.

The gastroscopy is performed in accordance with the indication.

A total of 2 culture samples will be taken from each participant. The culture samples are sent to the department of clinical microbiology, Herlev Hospital for cultivation, bacterial count and typing.

The first culture sample is taken by instilling 50ml sterile saline through the instrumentation channel with the gastroscope located in the fundus of the stomach . Approximately 10ml is aspirated through the same channel in the antrum of the stomach.

The second culture sample is taken from the gastroscope after the procedure by rinsing the instrumentation channel with sterile saline. A sample of approximately 10 ml is collected at the distal end of the gastroscope.

Samples are marked with the respective continuous registration numbers according to the randomization.

Side effects, discomfort and risks:

There are no side effects associated with the use chlorhexidine mouthwash.

There is some discomfort associated with the gastroscopy. This is not a result of participation in the trial.

Many patients feel slight discomfort when the gastroscope passes through the throat. The passage can stimulate the vomiting reflex. For this reason a gastroscopy is always performed with the patient in a left lateral position to ensure free airways. There may be mild soreness and irritation in the throat during and in the first few days after the gastroscopy.

The only discomfort that is directly linked to participation in the trial is the taste of chlorhexidine mouthwash for half of the participants.

There are no risks associated with participation in the trial, although there are some risks associated with the gastroscopy itself. These are bleeding from the stomach wall and perforation of the stomach or duodenum. These complications are very rare.

Ethics:

Since the participants are recruited after referral to gastroscopy from a general practitioner the indication for the gastroscopy has already been assessed and outweighs the above mentioned rare risks.

The only discomfort that is directly related to the trail is a brief sensation of bad taste in the mouth for half of the participants.

The results gained from the trial greatly overshadow the mild discomfort associated with the taste of chlorhexidine mouthwash.

Economy:

The above mentioned trial is a part of a PhD project which tries to bridge the gap between animal studies and the implementation of NOTES in daily clinical practice.

Salaries are funded through grants from the University of Copenhagen, Herlev Hospital Research Council and the Capitol Region of Denmark Research Foundation for Health Research. Operating costs are founded through grants from private foundations. There is no commercial interest in or support for the project.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Gastroscopy
Other: Chlorhexidine
Mouthwash with a 0,2 % chlorhexidine solution for 30 seconds
  • Active Comparator: Chlorhexidine mouthwash
    Participants randomized to chlorhexidine mouthwash prior to gastroscopy
    Intervention: Other: Chlorhexidine
  • No Intervention: No mouthwash
    Mouthwash is not performed prior to gastroscopy as is the standard today.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01154530
NOTES01
Yes
Anders Meller Donatsky, MD, resident, Phd-student, Herlev Hospital, Department of surgical gastroenterology
Herlev Hospital
  • Bispebjerg Hospital
  • University Hospital, Gentofte, Copenhagen
Principal Investigator: Anders Meller Donatsky, MD Herlev Hospital, Department of surgical gastroenterology
Study Director: Jacob Rosenberg, MD DSc Prof Herlev Hospital, Department of surgical gastroenterology
Study Director: Søren Meisner, MD Bispebjerg Hospital, Department of surgical gastroenterology
Study Director: Lars Nannestad Jørgensen, MD DSc prof Bispebjerg Hospital, Department of surgical gastroenterology
Study Director: Peter Vilmann, MD DSc Prof Gentofte Hospital, Department of surgical gastroenterology
Herlev Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP