Chlorhexidine Mouthwash and Bacterial Contamination During Endoscopy

NCT01154530 | Completed DMC

• 1 other identifier: NOTES01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroscopy

Keywords

Gastroscopy; Bacteria; Chlorhexidine; General surgery

Outcome Measures

Primary Outcomes (1)

• Quantification of culture samples

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

  1 week

Secondary Outcomes (2)

• The influence of PPI treatment on bacterial count

  1 week

• Bacteria species

  1 week

Study Arms (2)

Chlorhexidine mouthwash

ACTIVE COMPARATOR

Participants randomized to chlorhexidine mouthwash prior to gastroscopy

Other: Chlorhexidine

No mouthwash

NO INTERVENTION

Mouthwash is not performed prior to gastroscopy as is the standard today.

Interventions

Chlorhexidine OTHER

Mouthwash with a 0,2 % chlorhexidine solution for 30 seconds

Chlorhexidine mouthwash

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Removable prosthetic teeth.
• 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.

Sponsors & Collaborators

• Herlev Hospital: lead
• Bispebjerg Hospital: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (1)

Herlev Hospital, Department of surgical gastroenterology

Herlev, 2730, Denmark

Location

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Anders Meller Donatsky, MD

  Herlev Hospital, Department of surgical gastroenterology

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 1, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 17, 2011

Record last verified: 2010-12

Locations

DK (1)