Early Versus Delayed Operation for Perforated Appendicitis
|ClinicalTrials.gov Identifier: NCT00414375|
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : March 3, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Appendiceal Abscess||Procedure: Operation on Admission Procedure: Drainage and Interval Appendectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||March 2009|
Active Comparator: 1
Drainage with interval appendectomy
Procedure: Drainage and Interval Appendectomy
drainage with interval appendectomy
appendectomy on presentation
Procedure: Operation on Admission
Laparoscopic appendectomy on admission
- Pilot [ Time Frame: 3 months ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414375
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Shawn D St. Peter, MD||Children's Mercy Hospital|