Appendicitis
Conditions
Keywords
Polymetric Clips (Hem-o-Lok), Laparoscopic Appendectomy, Endoscopic Staplers
Brief summary
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.
Interventions
DEVICEPolymetric 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.
OTHEREndoscopic Staplers
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.
Sponsors
Duke University
Study design
Observational model
CASE_CONTROL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | Subjects will be followed for the duration of their hopsital stay, an expected average of 2-3 days. | 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. |
| Total Hospital Charges | Financial data will be gathered for the duration of the subjects hospital stay, an expected average of 2-3 days. | 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. |
| Operative time | Length of operation is approximately one and a half hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Surgical Outcomes | Immediatly Postoperative to 30 days postoperative | 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. |
Countries
United States
Outcome results
None listed