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NCT01189916 · ClinicalTrials.gov registry record · NA
Transrectal NOTES Appendectomy - Feasibility Study
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT01189916 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 4 participants.
The verdict
NCT01189916, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
Natural orifice translumenal endoscopic surgery (NOTES) has revolutionized the concept of minimally invasive surgery. NOTES is currently performed through transgastric or transvaginal approaches. The transvaginal approach is technically easier, but is only available to women. A transrectal approach has been proposed as a potential alternative to transvaginal NOTES for men. Fortunately, the technology to facilitate transrectal access and closure for NOTES has been in use for over twenty years, in the form of transanal endoscopic microsurgery (TEM) platforms. We hypothesize that transrectal NOTES appendectomy is feasible in humans using a flexible endoscope and a TEM platform to assist with transrectal access and closure. After a pre-clinical study involving 5 cadavers, we will perform a clinical study of 10 transrectal NOTES appendectomies in patients already scheduled to undergo laparoscopic total proctocolectomy or total abdominal colectomy. The tissues involved in the NOTES procedure will be removed as part of the patient's originally scheduled operation, reducing the risk of morbidity as a result of an inadequate transrectal closure or appendiceal stump leak. We will measure operative times, complication rates, peritoneal contamination, and assess the integrity of the rectotomy closures. We hope to show that transrectal NOTES appendectomy is clinically feasible in humans using a TEM platform.
Interventions
- PROCEDURE Endoscopically assisted Appendectomy Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01189916
The ClinicalTrials.gov registry entry for NCT01189916 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Endoscopically assisted Appendectomy Surgery is the first listed.
NCT01189916 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01189916 about?
NCT01189916 is a clinical study titled "Transrectal NOTES Appendectomy - Feasibility Study". Natural orifice translumenal endoscopic surgery (NOTES) has revolutionized the concept of minimally invasive surgery. NOTES is currently performed through transgastric or transvaginal approaches. The transvaginal approach is technically easier, but is only available to women. A transrectal approach ...
What is the current status of trial NCT01189916?
This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2010-08. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01189916?
The interventions under investigation include: Endoscopically assisted Appendectomy Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT01189916?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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