Prostatic Diseases Clinical Trial
Official title:
Prospective Evaluation of the Intraoperative Use of Translumenal Flexible Endoscopes During Combined Flexible and Laparoscopic Foregut and Urologic Surgery
NOTES access is safe and feasible in the controlled human setting and comparable to standard-of-care surgical techniques. NOTES exploration of the abdomen provides adequate visualization comparable to laparoscopy.
This is a prospective clinical trial to evaluate the feasibility of obtaining peritoneal
cavity access from natural orifice translumenal endoscopic surgery (NOTES) during combined
laparoscopic-endoscopic foregut surgery. Post-operative course will be compared with a
historical chart-review control group of patients undergoing standard laparoscopic foregut
and urologic surgery.
The study group will be compiled by open enrollment for male and female adult subjects
scheduled for combined laparoscopic-endoscopic surgery of the stomach, abdominal esophagus,
prostate, bladder, proximal small intestine or who meet inclusion and exclusion criteria.
The historical chart-review control group will be randomly chosen from patients from
2003-2006 having undergone combined laparoscopic-endoscopic surgery of the foregut,
prostate, or bladder and as determined by CPT coding.
The purpose of the study is to determine if NOTES access and abdominal exploration is
feasible, safe, offers comparable visualization to laparoscopy in a controlled human
setting.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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