NCT00981136

Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy

Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Appendicitis

Interventions

Type	Name	Description
PROCEDURE	Single Incision Laparoscopic Appendectomy	A single incision through the umbilicus to remove the appendix
PROCEDURE	3 port laparoscopic appendectomy	Standard 3 port laparoscopic appendectomy with intracorporeal stapling

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-11-01
• Completion: 2011-12-01
• First posted: 2009-09-22
• Last updated: 2013-02-15

Locations

1 site across 1 country: United States