Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00981136
First received: September 21, 2009
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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 Intervention
Appendicitis
Procedure: Single Incision Laparoscopic Appendectomy
Procedure: 3 port laparoscopic appendectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Post-operative infection [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Doses of analgesic [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Operative time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Cosmetic scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Length of Hospitalization [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Surgeon perception of difficulty [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Hospital/operative charges [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981136

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

No publications provided by Children's Mercy Hospital Kansas City

Additional 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
Study First Received: September 21, 2009
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Appendicitis
Appendectomy
Children
Laparoscopic
SILS

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

ClinicalTrials.gov processed this record on September 18, 2014