Early Versus Delayed Operation for Perforated Appendicitis

Appendiceal Abscess Clinical Trial

Official title:

Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414375
• Other study ID #: 06 11 164
• Status: Completed
• Phase: N/A
• First received: December 19, 2006
• Last updated: March 2, 2009
• Start date: December 2006
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess
• Appendiceal Abscess
• Appendicitis

Intervention

Procedure:
• Operation on Admission
Laparoscopic appendectomy on admission
• Drainage and Interval Appendectomy
drainage with interval appendectomy

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pilot		3 months	No
Secondary	PIP and PedsQL4 scores, time to full feeds, days of hospitalization, recurrent abscess, number of recurrences, number of CT scans, operating time		3 months	No