Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy
|ClinicalTrials.gov Identifier: NCT00981136|
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : February 15, 2013
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.
|Condition or disease||Intervention/treatment|
|Appendicitis||Procedure: Single Incision Laparoscopic Appendectomy Procedure: 3 port laparoscopic appendectomy|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis|
|Study Start Date :||August 2009|
|Primary Completion Date :||November 2010|
|Study Completion Date :||December 2011|
Active Comparator: SILS
Single Incision Laparoscopic Surgery (SILS) where a single incision in the umbilicus is all that is used to remove the appendix. The specific methods (staple/tie/port use/etc) will vary depending on surgeon.
Procedure: Single Incision Laparoscopic Appendectomy
A single incision through the umbilicus to remove the appendix
Other Name: SILS
Active Comparator: 3 port
Standard laparoscopic appendectomy with 3 ports and intracorporeal stapling.
Procedure: 3 port laparoscopic appendectomy
Standard 3 port laparoscopic appendectomy with intracorporeal stapling
Other Name: Laparoscopic Appendectomy
- Post-operative infection [ Time Frame: 6 weeks ]
- Doses of analgesic [ Time Frame: 3 days ]
- Operative time [ Time Frame: 1 day ]
- Cosmetic scores [ Time Frame: 6 months ]
- Length of Hospitalization [ Time Frame: 1 week ]
- Surgeon perception of difficulty [ Time Frame: 1 day ]
- Hospital/operative charges [ Time Frame: 1 week ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981136
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Shawn d St. Peter, MD||Children's Mercy Hospital Kansas City|