View Clinical Trial (Medical Research Study)

Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy - NCT00981136-64108(Clinical Trial 334248)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Kansas City
State:  
MO
Zip Code: 64108
Conditions: Appendicitis
Purpose: 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.
Study summary: 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: 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
Study is available at: 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
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.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.