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| Sponsored by: |
Children's Mercy Hospital Kansas City |
|---|---|
| Information provided by: | Children's Mercy Hospital Kansas City |
| ClinicalTrials.gov Identifier: | NCT00414375 |
Purpose
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 | Intervention |
|---|---|
|
Appendiceal Abscess |
Procedure: Operation on Admission Procedure: Drainage and Interval Appendectomy |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | October 2008 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Drainage with interval appendectomy
|
Procedure: Drainage and Interval Appendectomy
drainage with interval appendectomy
|
|
2: Experimental
appendectomy on presentation
|
Procedure: Operation on Admission
Laparoscopic appendectomy on admission
|
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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shawn D St. Peter, MD | (816)234-3575 ext 6465 | sspeter@cmh.edu |
| Contact: Susan W Sharp, PhD | (816)234-3575 ext 6670 | swsharp@cmh.edu |
| United States, Missouri | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Shawn D St. Peter, MD 816-234-3575 ext 6465 sspeter@cmh.edu | |
| Contact: Susan W Sharp, MD 816 234-3575 ext 6670 swsharp@cmh.edu | |
| Principal Investigator: Shawn D St. Peter, MD | |
| Sub-Investigator: Susan W Sharp, PhD | |
| Sub-Investigator: Daniel J Ostlie, MD | |
| Sub-Investigator: George W Holcomb III, MD | |
| Sub-Investigator: Jennifer Schurman, PhD | |
| Principal Investigator: | Shawn D St. Peter, MD | Children's Mercy Hospital |
More Information
| Study ID Numbers: | 06 11 164 |
| Study First Received: | December 19, 2006 |
| Last Updated: | November 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00414375 |
| Health Authority: | United States: Institutional Review Board |
|
Perforated Appendicitis Abscess Appendectomy |
|
Digestive System Diseases Gastrointestinal Diseases Appendicitis Abscess |
Suppuration Intestinal Diseases Gastroenteritis Inflammation |
|
Pathologic Processes Infection Cecal Diseases |
