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

Study Overview
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Brief Summary
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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.

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

Conditions
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Appendicitis

Intervention / Treatment
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* Device: Polymetric clips
* Other: Endoscopic Staplers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Less than 18 years of age Signs of appendiceal rupture or abcess on preoperative imaging studies (CT or ultrasound) Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Polymetric clips<br>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. | Device: Polymetric clips<br>* 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.<br>|
| Endoscopic Staplers<br>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. | Other: Endoscopic Staplers<br>* The study team will retrospectively identify patients who have undergone laparoscopic appendectomy 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Charts will be reviewed to calculate the number of days the subject was in the hospital. Clinical and financial outcomes of subjects enrolled for laparoscopic appendectomy using Hem-o-Lok will be compared to a historical (retrospective) cohort of patients who underwent appendectomy using endoscopic staplers. | Subjects will be followed for the duration of their hopsital stay, an expected average of 2-3 days. | 
| Total Hospital Charges | Data will be gathered on the expense of the subjects hospital stay from admission, surgery, to discharge. Clinical and financial outcomes of subjects enrolled for laparoscopic appendectomy using Hem-o-Lok will be compared to a historical (retrospective) cohort of patients who underwent appendectomy using endoscopic staplers. | Financial data will be gathered for the duration of the subjects hospital stay, an expected average of 2-3 days. | 
| Operative time | Subject's chart will be reviewed to gather operative start and stop times. Clinical and financial outcomes of subjects enrolled for laparoscopic appendectomy using Hem-o-Lok will be compared to a historical (retrospective) cohort of patients who underwent appendectomy using endoscopic staplers. | Length of operation is approximately one and a half hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Surgical Outcomes | Measures of surgical outcomes will be compared between the two procedures including rates of postoperative appendiceal stump dehiscence, hemorrhage, pneumonia, urinary tract infection, myocardial infarction, pulmonary embolism, deep vein thrombosis, and death. | Immediatly Postoperative to 30 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polymetric Clips (Hem-o-Lok), Laparoscopic Appendectomy, Endoscopic Staplers