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

Duke University

Status: Completed

Conditions: Appendicitis

Treatments: Other: Endoscopic Staplers; Device: Polymetric clips

Study type: Observational

Funder types: Other

Identifiers

NCT01830387

Pro00041869

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age or older
2. scheduled to undergo a laparoscopic appendectomy because of a diagnosis of appendicitis based on clinical history or radiographic imaging.

Exclusion criteria

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

Trial design

26 participants in 2 patient groups

Polymetric clips

Description:

The study team will prospectively enroll subjects with a diagnosis of appendicitis who are scheduled for laparoscopic appendectomy to have Hem-o-Lok® clips used for closure of the appendiceal stump. All subjects enrolled in the study will have their medical chart reviewed from consent to 30 days post operatively.

Treatment:

Device: Polymetric clips

Endoscopic Staplers

Description:

The study team will retrospectively identify patients who have undergone laparoscopic appendectomy during a one year time span by performing a database search. The operative notes will be reviewed for these patients to select patients who underwent ligation of the appendix with an endoscopic stapler.

Treatment:

Other: Endoscopic Staplers