Early Versus Delayed Operation for Perforated Appendicitis
Primary Purpose
Appendiceal Abscess
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Operation on Admission
Drainage and Interval Appendectomy
Sponsored by
About this trial
This is an interventional treatment trial for Appendiceal Abscess focused on measuring Perforated Appendicitis, Abscess, Appendectomy
Eligibility Criteria
Inclusion Criteria:
- Patients with perforated appendicitis and an abdominal abscess diagnosed on CT scan.
- Children of any age will be included.
Exclusion Criteria:
- Patients with immune deficiency
- Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).
- Acute sepsis or severe pain from perforation not allowing for delayed management.
Sites / Locations
- Children's Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Drainage with interval appendectomy
appendectomy on presentation
Outcomes
Primary Outcome Measures
Pilot
Secondary Outcome Measures
PIP and PedsQL4 scores, time to full feeds, days of hospitalization, recurrent abscess, number of recurrences, number of CT scans, operating time
Full Information
NCT ID
NCT00414375
First Posted
December 19, 2006
Last Updated
March 2, 2009
Sponsor
Children's Mercy Hospital Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT00414375
Brief Title
Early Versus Delayed Operation for Perforated Appendicitis
Official Title
Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Mercy Hospital Kansas City
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to scientifically evaluate two different operative strategies for perforated appendicitis with abscess.
The hypothesis is that the increased difficulty of early operation is balanced by the immense patient investment with delayed operation.
Detailed Description
This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis with abscess. This will be a pilot study.
Power calculations are not used for a pilot study. One group will undergo a primary laparoscopic appendectomy. The other group will receive intravenous antibiotics with drainage if possible and a laparoscopic appendectomy 10 weeks after initiation of treatment at presentation. All 7 general pediatric surgeons will be involved with the operations, who are all comfortable with these management arms. The surgeon will not induce a significant confounding variable into this study. The laparoscopic appendectomy is approached in the same manner by all members of our group. Those named on the form are qualified by the IRB to obtain consent and/or will be accountable for overseeing the study.
Both groups will have the same antibiotic regiment. All data will be analyzed on intention-to-treat basis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendiceal Abscess
Keywords
Perforated Appendicitis, Abscess, Appendectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Drainage with interval appendectomy
Arm Title
2
Arm Type
Experimental
Arm Description
appendectomy on presentation
Intervention Type
Procedure
Intervention Name(s)
Operation on Admission
Intervention Description
Laparoscopic appendectomy on admission
Intervention Type
Procedure
Intervention Name(s)
Drainage and Interval Appendectomy
Intervention Description
drainage with interval appendectomy
Primary Outcome Measure Information:
Title
Pilot
Time Frame
3 months
Secondary Outcome Measure Information:
Title
PIP and PedsQL4 scores, time to full feeds, days of hospitalization, recurrent abscess, number of recurrences, number of CT scans, operating time
Time Frame
3 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with perforated appendicitis and an abdominal abscess diagnosed on CT scan.
Children of any age will be included.
Exclusion Criteria:
Patients with immune deficiency
Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).
Acute sepsis or severe pain from perforation not allowing for delayed management.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn D St. Peter, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Versus Delayed Operation for Perforated Appendicitis
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