Clinical trial NCT00981136: Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy
Official title: Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: Appendicitis
Appendectomy
Children
Laparoscopic
SILS
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 360
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative infection
timeFrame: 6 weeks
Secondary outcomes:
measure: Doses of analgesic
timeFrame: 3 days
measure: Operative time
timeFrame: 1 day
measure: Cosmetic scores
timeFrame: 6 months
measure: Length of Hospitalization
timeFrame: 1 week
measure: Surgeon perception of difficulty
timeFrame: 1 day
measure: Hospital/operative charges
timeFrame: 1 week
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Shawn d St. Peter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: St Peter SD, Shah SR, Adibe OO, Sharp SW, Reading B, Cully B, Holcomb GW 3rd, Rivard DC. Saline vs Tissue Plasminogen Activator Irrigations after Drain Placement for Appendicitis-Associated Abscess: A Prospective Randomized Trial. J Am Coll Surg. 2015 Aug;221(2):390-6. doi: 10.1016/j.jamcollsurg.2015.03.043. Epub 2015 Mar 30.
citation: St Peter SD, Adibe OO, Iqbal CW, Fike FB, Sharp SW, Juang D, Lanning D, Murphy JP, Andrews WS, Sharp RJ, Snyder CL, Holcomb GW, Ostlie DJ. Irrigation versus suction alone during laparoscopic appendectomy for perforated appendicitis: a prospective randomized trial. Ann Surg. 2012 Oct;256(4):581-5. doi: 10.1097/SLA.0b013e31826a91e5.
citation: St Peter SD, Adibe OO, Juang D, Sharp SW, Garey CL, Laituri CA, Murphy JP, Andrews WS, Sharp RJ, Snyder CL, Holcomb GW 3rd, Ostlie DJ. Single incision versus standard 3-port laparoscopic appendectomy: a prospective randomized trial. Ann Surg. 2011 Oct;254(4):586-90. doi: 10.1097/SLA.0b013e31823003b5.