Transrectal NOTES Appendectomy - Feasibility Study
Completed · Not applicable
Conditions studied: Appendectomy, Laparoscopic, Endoscopy
In brief
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.
Key facts
- Study ID
- NCT01189916
- Run by
- Northwestern University
- People needed
- 4
- Starts
- 2010-08-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2015-02-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ability to undergo general anesthesia
- Age > 18 yrs
- ability to give informed consent
- requires total proctocolectomy,total abdominal colectomy, completion proctectomy, or sigmoidectomy
- absence of exclusion criteria
You may not qualify if…
- age < 18
- pregnancy
- emergency operation
- contraindication for laparoscopic surgery
Where it is running
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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