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

Chang, Steve S., M.D.

Status: Completed

Conditions: Postoperative Abscess

Treatments: Other: Oxygen Insufflation

Study type: Interventional

Funder types: Other

Identifiers

NCT01531413

AppyO2_SBCH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 1 patient group

Oxygen Insufflation

Experimental group

Description:

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

Treatment:

Other: Oxygen Insufflation