COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy (AppyO2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01531413
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : February 13, 2012
Santa Barbara Cottage Hospital
Information provided by (Responsible Party):
Chang, Steve S., M.D.

Brief 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.

Condition or disease Intervention/treatment Phase
Postoperative Abscess Other: Oxygen Insufflation Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Single-Blind, Randomized, Controlled Trial of Oxygen Insufflation to Reduce Incidence of Postoperative Abscess in Laparoscopic Appendectomy
Study Start Date : March 2006
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Oxygen Insufflation
At the end of the laparoscopic appendectomy we will desufflate the abdomen of CO2 then reinsufflate with oxygen to washout the CO2 leaving an oxygen rich environment
Other: Oxygen Insufflation
At the end of the case, abdomen will be desufflated with CO2 then insufflated with oxygen
Other Name: Oxygen

Primary Outcome Measures :
  1. Incidence of Postoperative Abscess [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01531413

Layout table for location information
United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93111
Sponsors and Collaborators
Chang, Steve S., M.D.
Santa Barbara Cottage Hospital
Layout table for investigator information
Principal Investigator: Steve S Chang, MD Santa Barbara Cottage Hospital
Layout table for additonal information
Responsible Party: Chang, Steve S., M.D. Identifier: NCT01531413    
Other Study ID Numbers: AppyO2_SBCH
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Pathologic Processes