Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy

Postoperative Abscess Clinical Trial

— AppyO2  

Official title:

Single-Blind, Randomized, Controlled Trial of Oxygen Insufflation to Reduce Incidence of Postoperative Abscess in Laparoscopic Appendectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531413
• Other study ID #: AppyO2_SBCH
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: February 8, 2012
• Start date: March 2006
• Est. completion date: August 2011

Study information

• Verified date: February 2012
• Source: Chang, Steve S., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Oxygen has inherent bactericidal properties. The investigators are testing to see if they can reduce the incidence of postoperative abscesses following laparoscopic appendectomy by insufflating with oxygen at the end of the case.

Description:

Intra-abdominal abscess a well-known complication of both open and laparoscopic appendectomy, especially in the setting of perforated and gangrenous appendicitis. The reviewed literature cites an incidence of about 10%. Besides peri-operative antibiotic administration there have been few developments to reduce this inherent risk. Oxygen rich environments are potently bactericidal, and thus it is our hypothesis that establishing an oxygen rich ambience within the abdomen at the conclusion of laparoscopy could curtail bacterial growth and subsequent abscess formation.

In the experimental arm, at the conclusion of all surgical dissection and manipulation, the carbon dioxide insufflate will be exchanged with oxygen to generate a high intra-abdominal concentration. Oxygen will be infused for 15 seconds as CO2 is allowed to escape through the open trocars. In the control arm Co2 will be allowed to escape through the open trocar ports without any oxygen flush. Patients will receive a standardized operation as well as standard post-operative care and follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Nonpregnant adults 18 or older

• Clinical or image proven appendicitis

• Undergoing Laparoscopic Appendectomy

Exclusion Criteria:

• Any pregnant females

• Anyone under the age of 18

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abscess
• Postoperative Abscess

Intervention

Other:
• Oxygen Insufflation
At the end of the case, abdomen will be desufflated with CO2 then insufflated with oxygen

Locations

Country	Name	City	State
United States	Santa Barbara Cottage Hospital	Santa Barbara	California

Sponsors (2)

Lead Sponsor	Collaborator
Chang, Steve S., M.D.	Santa Barbara Cottage Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Postoperative Abscess		4 weeks	No