NCT00414375

Early Versus Delayed Operation for Perforated Appendicitis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Appendiceal Abscess

Interventions

Type	Name	Description
PROCEDURE	Operation on Admission	Laparoscopic appendectomy on admission
PROCEDURE	Drainage and Interval Appendectomy	drainage with interval appendectomy

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2006-12-21
• Last updated: 2009-03-03

Locations

1 site across 1 country: United States