Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy (AppyO2)
Primary Purpose
Postoperative Abscess
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxygen Insufflation
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Abscess
Eligibility Criteria
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
Sites / Locations
- Santa Barbara Cottage Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxygen Insufflation
Arm 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
Outcomes
Primary Outcome Measures
Incidence of Postoperative Abscess
Secondary Outcome Measures
Full Information
NCT ID
NCT01531413
First Posted
February 7, 2012
Last Updated
February 8, 2012
Sponsor
Chang, Steve S., M.D.
Collaborators
Santa Barbara Cottage Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01531413
Brief Title
Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy
Acronym
AppyO2
Official Title
Single-Blind, Randomized, Controlled Trial of Oxygen Insufflation to Reduce Incidence of Postoperative Abscess in Laparoscopic Appendectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang, Steve S., M.D.
Collaborators
Santa Barbara Cottage Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Abscess
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxygen Insufflation
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Oxygen Insufflation
Other Intervention Name(s)
Oxygen
Intervention Description
At the end of the case, abdomen will be desufflated with CO2 then insufflated with oxygen
Primary Outcome Measure Information:
Title
Incidence of Postoperative Abscess
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve S Chang, MD
Organizational Affiliation
Santa Barbara Cottage Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93111
Country
United States
12. IPD Sharing Statement
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Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy
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