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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polymetric clips | 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. |
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| Endoscopic Staplers | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymetric clips | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients, aged 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.
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| Name | Affiliation | Role |
|---|---|---|
| Chan Park, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Center for Metabolic and Weight Loss Surgery | Durham | North Carolina | 27704 | United States |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| Endoscopic Staplers | Other | 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. |
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |