Early Versus Delayed Operation for Perforated Appendicitis

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00414375
First received: December 19, 2006
Last updated: March 2, 2009
Last verified: March 2009

December 19, 2006
March 2, 2009
December 2006
February 2009   (final data collection date for primary outcome measure)
Pilot [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Pilot
Complete list of historical versions of study NCT00414375 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
PIP and PedsQL4 scores, time to full feeds, days of hospitalization, recurrent abscess, number of recurrences, number of CT scans, operating time
Not Provided
Not Provided
 
Early Versus Delayed Operation for Perforated Appendicitis
Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Appendiceal Abscess
  • Procedure: Operation on Admission
    Laparoscopic appendectomy on admission
  • Procedure: Drainage and Interval Appendectomy
    drainage with interval appendectomy
  • Active Comparator: 1
    Drainage with interval appendectomy
    Intervention: Procedure: Drainage and Interval Appendectomy
  • Experimental: 2
    appendectomy on presentation
    Intervention: Procedure: Operation on Admission
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00414375
06 11 164
Not Provided
Shawn St. Peter, Children's Mercy Hospital
Children's Mercy Hospital Kansas City
Not Provided
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital
Children's Mercy Hospital Kansas City
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP