Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy

February 13, 2013 updated by: Shawn St. Peter, Children's Mercy Hospital Kansas City

Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Laparoscopic Appendectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-operative infection
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Operative time
Time Frame: 1 day
1 day
Length of Hospitalization
Time Frame: 1 week
1 week
Doses of analgesic
Time Frame: 3 days
3 days
Cosmetic scores
Time Frame: 6 months
6 months
Surgeon perception of difficulty
Time Frame: 1 day
1 day
Hospital/operative charges
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 21, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 13, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09 07 133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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