Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy (AppyO2)
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ClinicalTrials.gov Identifier: NCT01531413 |
Recruitment Status :
Completed
First Posted : February 13, 2012
Last Update Posted : February 13, 2012
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Condition or disease | Intervention/treatment | Phase |
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Postoperative Abscess | Other: Oxygen Insufflation | Not Applicable |
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 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 |

Arm | Intervention/treatment |
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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
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Other: Oxygen Insufflation
At the end of the case, abdomen will be desufflated with CO2 then insufflated with oxygen
Other Name: Oxygen |
- Incidence of Postoperative Abscess [ Time Frame: 4 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531413
United States, California | |
Santa Barbara Cottage Hospital | |
Santa Barbara, California, United States, 93111 |
Principal Investigator: | Steve S Chang, MD | Santa Barbara Cottage Hospital |
Responsible Party: | Chang, Steve S., M.D. |
ClinicalTrials.gov Identifier: | NCT01531413 |
Other Study ID Numbers: |
AppyO2_SBCH |
First Posted: | February 13, 2012 Key Record Dates |
Last Update Posted: | February 13, 2012 |
Last Verified: | February 2012 |
Abscess Suppuration Infection Inflammation Pathologic Processes |