Appendicitis Clinical Trial
Official title:
Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis
This is a prospective trial of single incision versus standard 3-port laparoscopic
appendectomy.
The hypothesis is that there may a difference in wound infection rates, operative time,
doses of analgesics post-operatively, and patient/parent perception of scars.
This is a prospective, randomized clinical trial involving patients who present to the
hospital with non-perforated appendicitis. We will offer enrollment to several institutions
provided they receive institutional approval.
There are likely several parameters that will show small differences between groups, and
this study will precisely quantify them to allow for adequate consultation from surgeons to
families dealing with acute appendicitis. One theoretical concern over the SILS approach is
that the exposure of the appendix to the wound could increase the rate of infectious
complications; therefore, this is the primary outcome variable. The documented rate of
infectious complications at our institution in patients with non-perforated appendicitis is
0.6%. An unacceptable and clinically relevant rise to 5% may curtail enthusiasm for the new
technique. Using a power of 0.9 with an α of 0.05, the sample size is 360 total patients or
180 in each arm.
After the procedure, both groups will be managed in the same manner per routine care. They
will be discharged when tolerating a regular diet and their pain is well-controlled on oral
pain medication. Cosmetic scores will be obtained at 6 weeks and 6 months.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 1/Phase 2 | |
| Recruiting |
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|
||
| Recruiting |
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Phase 4 | |
| Recruiting |
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| Completed |
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| Completed |
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| Completed |
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| Completed |
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| Completed |
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| Completed |
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Phase 2 |