Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis

Stopped early · Not applicable

Conditions studied: Appendicitis

In brief

Recent advances in laparoscopic instrumentation have made it possible to perform intra-abdominal operations entirely through a small incision that can be hidden within the umbilicus. The goal is to perform surgery with fewer incisions and no visible scars. Other potential benefits are faster recovery, less pain, and fewer wound complications. The term SILS (Single Incision Laparoscopic Surgery) is being used to describe such techniques, and many have touted SILS as a major breakthrough in minimally-invasive surgery, moving the field closer to surgery that is bloodless, incisionless, and painless. Despite the hype, prospective comparisons of SILS versus conventional laparoscopy are lacking. Results of SILS procedures have generally been limited to case reports and small case series that lack controls. The investigators propose to conduct a prospective, randomized, single-center trial of SILS appendectomy versus conventional laparoscopic appendectomy to treat acute appendicitis. Primary end-points are operative time, complication rate, postoperative pain, recovery time, and long-term cosmetic outcome. The investigators hypothesize SILS appendectomy is equivalent to laparoscopic appendectomy with respect to operative time, complication rate, postoperative pain, and recovery time while providing a better cosmetic outcome.

Key facts

Study ID

NCT00997516

Run by

University of California, San Francisco

People needed

75

Starts

2010-05-01

Expected to finish

2014-01-01

Last updated by the study team

2014-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Suspected acute appendicitis on clinical and radiographic (CT) grounds

You may not qualify if…

• Phlegmon, mass, peri-appendicecal abscess, or diffuse peritonitis
• Prior open laparotomy with incision through the umbilicus
• Body Mass Index > 35
• Age <18 years
• Mental illness, dementia, or inability to provide informed consent
• Chronic pain requiring daily medication (including opiate and NSAIDs)
• Pregnancy
• Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Where it is running

• UCSF Medical Center — San Francisco, California, United States
• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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