Status:
TERMINATED
Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Appendicitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 pe...
Detailed Description
EXPERIMENTAL DESIGN AND METHODS Patient Enrollment: The study population will consist of patients who come to the emergency room with acute abdominal pain and are found to have acute appendicitis on t...
Eligibility Criteria
Inclusion
- 1\. Suspected acute appendicitis on clinical and radiographic (CT) grounds
Exclusion
- 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)
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00997516
Start Date
May 1 2010
End Date
January 1 2014
Last Update
August 22 2014
Active Locations (2)
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1
UCSF Medical Center
San Francisco, California, United States, 94143
2
University of California, San Francisco
San Francisco, California, United States, 94143