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Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy

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ClinicalTrials.gov Identifier: NCT00981136
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City

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.

Condition or disease Intervention/treatment
Appendicitis Procedure: Single Incision Laparoscopic Appendectomy Procedure: 3 port laparoscopic appendectomy

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis
Study Start Date : August 2009
Primary Completion Date : November 2010
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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.
Procedure: Single Incision Laparoscopic Appendectomy
A single incision through the umbilicus to remove the appendix
Other Name: SILS
Active Comparator: 3 port
Standard laparoscopic appendectomy with 3 ports and intracorporeal stapling.
Procedure: 3 port laparoscopic appendectomy
Standard 3 port laparoscopic appendectomy with intracorporeal stapling
Other Name: Laparoscopic Appendectomy

Primary Outcome Measures :
  1. Post-operative infection [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Doses of analgesic [ Time Frame: 3 days ]
  2. Operative time [ Time Frame: 1 day ]
  3. Cosmetic scores [ Time Frame: 6 months ]
  4. Length of Hospitalization [ Time Frame: 1 week ]
  5. Surgeon perception of difficulty [ Time Frame: 1 day ]
  6. Hospital/operative charges [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981136

United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Principal Investigator: Shawn d St. Peter, MD Children's Mercy Hospital Kansas City

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shawn St. Peter, MD, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00981136     History of Changes
Other Study ID Numbers: 09 07 133
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases