Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
NCT Number: NCT00981136
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.
Looking for future studies?
Notify Me1 month–18 year
All sexes
Interventional
Not applicable
Kansas City, Missouri, 64108, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single incision through the umbilicus to remove the appendix
Other names: SILS
Standard 3 port laparoscopic appendectomy with intracorporeal stapling
Other names: Laparoscopic Appendectomy
Time frame: 6 weeks
Time frame: 3 days
Time frame: 1 day
Time frame: 6 months
Time frame: 1 week
Time frame: 1 day
Time frame: 1 week
Children's Mercy Hospital Kansas City
Other
Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05002829
Appendicitis, Cecal Diseases
Denver, Colorado, United States
View Trial DetailsNCT05887414
Appendicitis, Cecal Diseases
Baldwin Park, California, United States
View Trial DetailsNCT05209061
Appendicitis, Cecal Diseases
Copenhagen, Denmark
View Trial DetailsNCT04986397
Appendicitis, Cecal Diseases
Boston, Massachusetts, United States
View Trial Details