Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy (AppyO2)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Single-Blind, Randomized, Controlled Trial of Oxygen Insufflation to Reduce Incidence of Postoperative Abscess in Laparoscopic Appendectomy|
- Incidence of Postoperative Abscess [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531413
|United States, California|
|Santa Barbara Cottage Hospital|
|Santa Barbara, California, United States, 93111|
|Principal Investigator:||Steve S Chang, MD||Santa Barbara Cottage Hospital|