Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy
Primary Purpose
Appendicitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single Incision Laparoscopic Appendectomy
3 port laparoscopic appendectomy
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis focused on measuring Appendicitis, Appendectomy, Children, Laparoscopic, SILS
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
Sites / Locations
- Children's Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
SILS
3 port
Arm 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.
Standard laparoscopic appendectomy with 3 ports and intracorporeal stapling.
Outcomes
Primary Outcome Measures
Post-operative infection
Secondary Outcome Measures
Doses of analgesic
Operative time
Cosmetic scores
Length of Hospitalization
Surgeon perception of difficulty
Hospital/operative charges
Full Information
NCT ID
NCT00981136
First Posted
September 21, 2009
Last Updated
February 13, 2013
Sponsor
Children's Mercy Hospital Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT00981136
Brief Title
Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy
Official Title
Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
Appendicitis, Appendectomy, Children, Laparoscopic, SILS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SILS
Arm Type
Active Comparator
Arm 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.
Arm Title
3 port
Arm Type
Active Comparator
Arm Description
Standard laparoscopic appendectomy with 3 ports and intracorporeal stapling.
Intervention Type
Procedure
Intervention Name(s)
Single Incision Laparoscopic Appendectomy
Other Intervention Name(s)
SILS
Intervention Description
A single incision through the umbilicus to remove the appendix
Intervention Type
Procedure
Intervention Name(s)
3 port laparoscopic appendectomy
Other Intervention Name(s)
Laparoscopic Appendectomy
Intervention Description
Standard 3 port laparoscopic appendectomy with intracorporeal stapling
Primary Outcome Measure Information:
Title
Post-operative infection
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Doses of analgesic
Time Frame
3 days
Title
Operative time
Time Frame
1 day
Title
Cosmetic scores
Time Frame
6 months
Title
Length of Hospitalization
Time Frame
1 week
Title
Surgeon perception of difficulty
Time Frame
1 day
Title
Hospital/operative charges
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn d St. Peter, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26141467
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.
Results Reference
derived
PubMed Identifier
22964730
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.
Results Reference
derived
PubMed Identifier
21946218
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.
Results Reference
derived
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Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy
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