Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy

NCT ID: NCT01531413

Last Updated: 2012-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2011-08-31

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.

Conditions

Postoperative Abscess

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Oxygen Insufflation

Intervention Type: OTHER

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

Interventions

Oxygen Insufflation

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

Intervention Type: OTHER

Other Intervention Names

Oxygen

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santa Barbara Cottage Hospital

OTHER

Sponsor Role: collaborator

Chang, Steve S., M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve S Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Santa Barbara Cottage Hospital

Locations

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Countries

United States

Other Identifiers

AppyO2_SBCH

Identifier Type: -

Identifier Source: org_study_id