Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414375
Status:
COMPLETED
Last Update Posted:
2009-03-03
First Post:
2006-12-19
Brief Title:
Early Versus Delayed Operation for Perforated Appendicitis
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Early Versus Delayed Operation for Perforated Appendicitis With Abscess a Pilot Study
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None