Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy - NCT00981136-64108 (Clinical Trial 334248)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy334248.aspx
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| City: |
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Kansas City |
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State:
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MO |
| Zip Code: |
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64108 |
| Conditions: |
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Appendicitis |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- Children under 18 years
- Non-perforated appendicitis
Exclusion Criteria:
- Perforated appendicitis as identified as a hole in the appendix for fecalith in the
abdomen |
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| Study is available at: |
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Children's Mercy Hospital
Kansas City, MO 64108
United States
Primary Contact:
Shawn D St. Peter, MD
Email: sspeter@cmh.edu
Phone: 816-983-6479
Secondary Contact:
Shawn D St. Peter, MD
Email: sspeter@cmh.edu
Phone: 816 983 6479 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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