Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy

Appendicitis Clinical Trial

Official title:

Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981136
• Other study ID #: 09 07 133
• Status: Completed
• Phase: N/A
• First received: September 21, 2009
• Last updated: February 13, 2013
• Start date: August 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• Single Incision Laparoscopic Appendectomy
A single incision through the umbilicus to remove the appendix
• 3 port laparoscopic appendectomy
Standard 3 port laparoscopic appendectomy with intracorporeal stapling

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative infection		6 weeks	Yes
Secondary	Doses of analgesic		3 days	No
Secondary	Operative time		1 day	No
Secondary	Cosmetic scores		6 months	No
Secondary	Length of Hospitalization		1 week	No
Secondary	Surgeon perception of difficulty		1 day	No
Secondary	Hospital/operative charges		1 week	No