Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention
Gastroscopy
Other: Chlorhexidine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Chlorhexidine Mouthwash and Bacterial Contamination During Endoscopy. Implementation of Chlorhexidine Mouthwash Before Transgastric NOTES

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Enrollment: 102
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chlorhexidine mouthwash
Participants randomized to chlorhexidine mouthwash prior to gastroscopy
Other: Chlorhexidine
Mouthwash with a 0,2 % chlorhexidine solution for 30 seconds
No Intervention: No mouthwash
Mouthwash is not performed prior to gastroscopy as is the standard today.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154530

Locations
Denmark
Herlev Hospital, Department of surgical gastroenterology
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Investigators
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
  More Information

No publications provided

Responsible Party: Anders Meller Donatsky, MD, resident, Phd-student, Herlev Hospital, Department of surgical gastroenterology
ClinicalTrials.gov Identifier: NCT01154530     History of Changes
Other Study ID Numbers: NOTES01
Study First Received: June 29, 2010
Last Updated: August 16, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
Gastroscopy
Bacteria
Chlorhexidine
General surgery

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014