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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Patients will have the standard laparoscopic procedure and the NOTES procedure will be added. The surgical procedure will require two operating teams: one led by a laparoscopic surgeon, the other by an endoscopic surgeon. During the usual course of the surgery, the flexible endoscope will be passed through the mouth urethra top gain access to the peritoneal cavity.
chart review of historical data from control group
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States
30 day Post-op NOTES feasibility outcomes:
* Number of successful NOTES access attempts * Number of failed NOTES access attempts * Injury to collateral organs or structures * Time to gain access to peritoneal cavity * Necessary balloon dilator size required for translumenal passage of endoscope
Time frame: 30 days post-op
30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery
Description: Mortality Post-Op Mobidity repeat sugery Intra-Op or Post-Op RBC Transfusion Intra-Abdominal Abscess Superficial Surgical Site Infection Antibiotics\>24th Post-Op Safety Issue?: Yes
Time frame: 30 Day Post-OP
30 Day NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration
Description: Identification of Specified Abdominal and Pelvic Organs Time to Adequately Visualize Specified Abdominal and Pelvic Organs Comparitive findings between standardaized abdominal exploration between laparoscopy and NOTES techniques
Time frame: 30 Day Post - Op
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.