Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy

Not Applicable

Completed

• Conditions: Appendicitis
• Interventions: Procedure: Single Incision Laparoscopic Appendectomy; Procedure: 3 port laparoscopic appendectomy

• Registration Number: NCT00981136
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief 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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2010-11
• Study Completion: 2011-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-13
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SILS	Single Incision Laparoscopic Appendectomy	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.
3 port	3 port laparoscopic appendectomy	Standard laparoscopic appendectomy with 3 ports and intracorporeal stapling.

Primary Outcome Measures

Name	Time	Method
Post-operative infection	6 weeks

Secondary Outcome Measures

Name	Time	Method
Doses of analgesic	3 days
Operative time	1 day
Cosmetic scores	6 months
Length of Hospitalization	1 week
Surgeon perception of difficulty	1 day
Hospital/operative charges	1 week

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States