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OpenTrials
Completed

NCT Number: NCT01531413

Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen Insufflation

Other

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

Other names: Oxygen

Primary outcomes

  1. Incidence of Postoperative Abscess

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Chang, Steve S., M.D.

Indiv

Collaborators

  • Santa Barbara Cottage Hospital

Registry information

Official study title

Single-Blind, Randomized, Controlled Trial of Oxygen Insufflation to Reduce Incidence of Postoperative Abscess in Laparoscopic Appendectomy

Acronym: AppyO2

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Feb 13, 2012
Registry last updated
Feb 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.