Appendiceal Abscess Clinical Trial
Official title:
Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03770897 -
Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome
|
N/A |