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CompletedNCT01531413AppyO2Updated Feb 13, 2012

Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy

An interventional study of Oxygen Insufflation in Postoperative Abscess, sponsored by Chang, Steve S., M.D.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-13.

Sponsored by Chang, Steve S., M.D. · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postoperative Abscess

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03

In context

Abscess

149 studies on the registry are indexed under Abscess; 32 are open to participants now.

This study's enrollment of 100 is close to the median of 96 across 102 interventional studies indexed under Abscess.

Browse Abscess studies →

Lead sponsor

Chang, Steve S., M.D. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Nonpregnant adults 18 or older
  • Clinical or image proven appendicitis
  • Undergoing Laparoscopic Appendectomy

Exclusion criteria

Exclusion Criteria:

  • Any pregnant females
  • Anyone under the age of 18
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • 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

Interventions

  • OtherOxygen Insufflation

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

    Also known as: Oxygen

06

What researchers measure

Primary outcomes

  1. Incidence of Postoperative Abscess

    Time frame: 4 weeks

07

Study locations

1 site
  • Santa Barbara Cottage Hospital
    Santa Barbara, California 93111, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01531413
Lead sponsor
Chang, Steve S., M.D.
Collaborators
Santa Barbara Cottage Hospital
Responsible party
Sponsor
First posted
Feb 13, 2012
Start date
Mar 2006
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Feb 13, 2012

Study contacts

Steve S Chang, MD
principal investigator · Santa Barbara Cottage Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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