Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy

Not Applicable

Completed

• Conditions: Postoperative Abscess
• Interventions: Other: Oxygen Insufflation

• Registration Number: NCT01531413
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-03
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-02
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-08
• Last Update Submitted: 2012-02-08
• Study First Posted: 2012-02-13
• Last Update Posted: 2012-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxygen Insufflation	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

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative Abscess	4 weeks

Trial Locations

Locations (1)

Santa Barbara Cottage Hospital; 🇺🇸 Santa Barbara, California, United States