Comparative Study of Polymetric Clips (Hem-o-Lok) Versus Historical Endoscopic Staplers for Laparoscopic Appendectomy

Completed

Conditions studied: Appendicitis

In brief

The purpose of this study is to compare the clinical outcomes and the operative costs of appendectomy performed with the Hem-O-Lok polymetric clips compared to endoscopic staplers. Prospective data will be collected before, during, and after surgery on patients undergoing a laparoscopic appendectomy that have the Hem-o-Lok ® stapler used to close the stump after the appendix is removed. Use of the Hem-o-Lok ® stapler is standard for appendectomy patients at Duke Regional Hospital. Retrospective data will be collected from patients who had an appendectomy prior to 1/2012 using a different clip as part of their surgery, or an open appendectomy to compare outcomes.

Key facts

Study ID

NCT01830387

Run by

Duke University

People needed

26

Starts

2013-04-01

Expected to finish

2014-10-01

Last updated by the study team

2016-04-19

Who can join

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

You may qualify if…

• 18 years of age or older
• scheduled to undergo a laparoscopic appendectomy because of a diagnosis of appendicitis based on clinical history or radiographic imaging.

You may not qualify if…

• Less than 18 years of age
• Signs of appendiceal rupture or abcess on preoperative imaging studies (CT or ultrasound)
• Inability to provide informed consent

Where it is running

• Duke Center for Metabolic and Weight Loss Surgery — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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