Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis

Conditions
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Appendicitis

Intervention / Treatment
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* Procedure: Single Incision Laparoscopic Appendectomy
* Procedure: 3 port laparoscopic appendectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SILS<br>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<br>* A single incision through the umbilicus to remove the appendix<br>* Other names: SILS;|
| Active Comparator: 3 port<br>Standard laparoscopic appendectomy with 3 ports and intracorporeal stapling. | Procedure: 3 port laparoscopic appendectomy<br>* Standard 3 port laparoscopic appendectomy with intracorporeal stapling<br>* Other names: Laparoscopic Appendectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative infection |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appendicitis, Appendectomy, Children, Laparoscopic, SILS