Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy

Children's Mercy Hospital Kansas City

Status: Completed

Conditions: Appendicitis

Treatments: Procedure: Single Incision Laparoscopic Appendectomy; Procedure: 3 port laparoscopic appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00981136

09 07 133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

SILS

Active Comparator group

Description:

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.

Treatment:

Procedure: Single Incision Laparoscopic Appendectomy

3 port

Active Comparator group

Description:

Standard laparoscopic appendectomy with 3 ports and intracorporeal stapling.

Treatment:

Procedure: 3 port laparoscopic appendectomy