Single-Blind, Randomized, Controlled Trial of Oxygen Insufflation to Reduce Incidence of Postoperative Abscess in Laparoscopic Appendectomy
| Registry | NCT01531413, acronym AppyO2 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: single, prevention |
| Enrollment | 100 (Actual) |
| Sponsor | Chang, Steve S., M.D. (Indiv); collaborators: Santa Barbara Cottage Hospital |
| Conditions | Postoperative Abscess |
| Interventions | Oxygen Insufflation (Other) |
| Dates | start 2006-03-01, primary completion 2011-08-01, completion 2011-08-01, first posted 2012-02-13, last updated 2012-02-13 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Abscess All trials of Oxygen Insufflation
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Oxygen Insufflation | Experimental | Other: 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 |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Santa Barbara Cottage Hospital | Santa Barbara, California | United States |