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NCT01830387 · ClinicalTrials.gov registry record
Comparative Study of Polymetric Clips (Hem-o-Lok) Versus Historical Endoscopic Staplers for Laparoscopic Appendectomy
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 26
- Enrollment target
NCT01830387: Completed study, sponsored by Duke University.
NCT01830387 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01830387 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 26 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Polymetric clips
- OTHER Endoscopic Staplers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-10 |
What the finished NCT01830387 record still lists
NCT01830387 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 26 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Polymetric clips is the first listed.
NCT01830387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01830387 about?
NCT01830387 is a clinical study titled "Comparative Study of Polymetric Clips (Hem-o-Lok) Versus Historical Endoscopic Staplers for Laparoscopic Appendectomy". 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...
What is the current status of trial NCT01830387?
This trial is currently completed. The enrollment target is 26 participants. The study started on 2013-04. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01830387?
The interventions under investigation include: Polymetric clips (DEVICE), Endoscopic Staplers (OTHER).
Who is sponsoring clinical trial NCT01830387?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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