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

• ClinicalTrials.gov Identifier: NCT01531413
• Recruitment Status: Completed
• First Posted: February 13, 2012
• Last Update Posted: February 13, 2012
• Sponsor: Chang, Steve S., M.D.
• Collaborator: Santa Barbara Cottage Hospital
• Information provided by (Responsible Party): Chang, Steve S., M.D.

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: Steve S Chang, MD; Santa Barbara Cottage Hospital

More Information

• Responsible Party: Chang, Steve S., M.D.
• ClinicalTrials.gov Identifier: NCT01531413
• Other Study ID Numbers: AppyO2_SBCH
• First Posted: February 13, 2012
• Last Update Posted: February 13, 2012
• Last Verified: February 2012

Additional relevant MeSH terms:

Abscess; Suppuration; Infection; Inflammation; Pathologic Processes