NCT01531413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2012

Completed
Last Updated

February 13, 2012

Status Verified

February 1, 2012

Enrollment Period

5.4 years

First QC Date

February 7, 2012

Last Update Submit

February 8, 2012

Conditions

Postoperative Abscess

Outcome Measures

Primary Outcomes (1)

  • Incidence of Postoperative Abscess

    4 weeks

Study Arms (1)

Oxygen Insufflation

EXPERIMENTAL

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

Interventions

Oxygen InsufflationOTHER

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

Also known as: Oxygen
Oxygen Insufflation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nonpregnant adults 18 or older
  • Clinical or image proven appendicitis
  • Undergoing Laparoscopic Appendectomy

You may not qualify if:

  • Any pregnant females
  • Anyone under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Barbara Cottage Hospital

Santa Barbara, California, 93111, United States

Location

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Steve S Chang, MD

    Santa Barbara Cottage Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 13, 2012

Study Start

March 1, 2006

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 13, 2012

Record last verified: 2012-02

Locations

US(1)