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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: Completed NA study, sponsored by Northwestern University.
NCT01189916 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01189916 record still lists
NCT01189916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Endoscopically assisted Appendectomy Surgery is the first listed.
NCT01189916 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01189916's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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