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Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy

Single-Blind, Randomized, Controlled Trial of Oxygen Insufflation to Reduce Incidence of Postoperative Abscess in Laparoscopic Appendectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01531413
Acronym
AppyO2
Enrollment
100
Registered
2012-02-13
Start date
2006-03-31
Completion date
2011-08-31
Last updated
2012-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Abscess

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.

Interventions

OTHEROxygen Insufflation

At the end of the case, abdomen will be desufflated with CO2 then insufflated with oxygen

Sponsors

Santa Barbara Cottage Hospital
CollaboratorOTHER
Chang, Steve S., M.D.
Lead SponsorINDIV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Incidence of Postoperative Abscess4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026