Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy
NCT ID: NCT00981136
Last Updated: 2013-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
360 participants
INTERVENTIONAL
2009-08-31
2011-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SILS
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.
Single Incision Laparoscopic Appendectomy
A single incision through the umbilicus to remove the appendix
3 port
Standard laparoscopic appendectomy with 3 ports and intracorporeal stapling.
3 port laparoscopic appendectomy
Standard 3 port laparoscopic appendectomy with intracorporeal stapling
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-perforated appendicitis
Exclusion Criteria
1 Month
18 Years
ALL
No
Sponsors
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Children's Mercy Hospital Kansas City
OTHER
Responsible Party
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Shawn St. Peter
MD
Principal Investigators
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Shawn d St. Peter, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Locations
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Children's Mercy Hospital
Kansas City, Missouri, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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09 07 133
Identifier Type: -
Identifier Source: org_study_id
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