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NCT00997516 · ClinicalTrials.gov registry record · NA
Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis
A NA study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- NA
- Development phase
- 75
- Enrollment target
NCT00997516 is a NA study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 75 participants.
The verdict
NCT00997516, a NA study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
Study Summary
Recent advances in laparoscopic instrumentation have made it possible to perform intra-abdominal operations entirely through a small incision that can be hidden within the umbilicus. The goal is to perform surgery with fewer incisions and no visible scars. Other potential benefits are faster recovery, less pain, and fewer wound complications. The term SILS (Single Incision Laparoscopic Surgery) is being used to describe such techniques, and many have touted SILS as a major breakthrough in minimally-invasive surgery, moving the field closer to surgery that is bloodless, incisionless, and painless. Despite the hype, prospective comparisons of SILS versus conventional laparoscopy are lacking. Results of SILS procedures have generally been limited to case reports and small case series that lack controls. The investigators propose to conduct a prospective, randomized, single-center trial of SILS appendectomy versus conventional laparoscopic appendectomy to treat acute appendicitis. Primary end-points are operative time, complication rate, postoperative pain, recovery time, and long-term cosmetic outcome. The investigators hypothesize SILS appendectomy is equivalent to laparoscopic appendectomy with respect to operative time, complication rate, postoperative pain, and recovery time while providing a better cosmetic outcome.
Interventions
- PROCEDURE SILS appendectomy
- PROCEDURE conventional laparoscopic appendectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00997516
The ClinicalTrials.gov registry entry for NCT00997516 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SILS appendectomy is the first listed.
NCT00997516 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00997516 about?
NCT00997516 is a clinical study titled "Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis". Recent advances in laparoscopic instrumentation have made it possible to perform intra-abdominal operations entirely through a small incision that can be hidden within the umbilicus. The goal is to perform surgery with fewer incisions and no visible scars. Other potential benefits are faster recover...
What is the current status of trial NCT00997516?
This trial is currently terminated. It is a NA study. The enrollment target is 75 participants. The study started on 2010-05. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00997516?
The interventions under investigation include: SILS appendectomy (PROCEDURE), conventional laparoscopic appendectomy (PROCEDURE).
Who is sponsoring clinical trial NCT00997516?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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