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

This study has been completed.
Sponsor:
Collaborator:
Santa Barbara Cottage Hospital
Information provided by (Responsible Party):
Chang, Steve S., M.D.
ClinicalTrials.gov Identifier:
NCT01531413
First received: February 7, 2012
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Postoperative Abscess
Other: Oxygen Insufflation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Single-Blind, Randomized, Controlled Trial of Oxygen Insufflation to Reduce Incidence of Postoperative Abscess in Laparoscopic Appendectomy

Resource links provided by NLM:


Further study details as provided by Chang, Steve S., M.D.:

Primary Outcome Measures:
  • Incidence of Postoperative Abscess [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: March 2006
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
At the end of the case, abdomen will be desufflated with CO2 then insufflated with oxygen
Other Name: Oxygen

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01531413

Locations
United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93111
Sponsors and Collaborators
Chang, Steve S., M.D.
Santa Barbara Cottage Hospital
Investigators
Principal Investigator: Steve S Chang, MD Santa Barbara Cottage Hospital
  More Information

No publications provided

Responsible Party: Chang, Steve S., M.D.
ClinicalTrials.gov Identifier: NCT01531413     History of Changes
Other Study ID Numbers: AppyO2_SBCH
Study First Received: February 7, 2012
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Abscess
Suppuration
Infection
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014