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OpenTrials
Completed

NCT Number: NCT00981136

Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Incision Laparoscopic Appendectomy

Procedure

A single incision through the umbilicus to remove the appendix

Other names: SILS

3 port laparoscopic appendectomy

Procedure

Standard 3 port laparoscopic appendectomy with intracorporeal stapling

Other names: Laparoscopic Appendectomy

Primary outcomes

  1. Post-operative infection

    Time frame: 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Sep 22, 2009
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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