Randomized blinded trial comparing NOTES with laparoscopy reveals no difference in immunologic parameters

Background: Natural Orifice Transluminal OrificeSurgery (NOTES) is being investigated for human use as a new minimally invasive procedure. We compared NOTES with the current gold standard laparoscopy.
Hypothesis: Animals undergoing NOTES will reveal greater hemodynamic instability due to uncontrolled insufflation pressures. No difference in the immunologic impact as measured by Interleukin-1b will be realized.
Design: Randomized blinded trial using permuted block design
Setting: Experimental surgery in a porcine survival model
Methods: 12 swine were randomized to diagnostic peritoneoscopy with biopsy by NOTES using air insufflation or by standard CO2 laparoscopy. Invasive monitoring of hemodynamic parameters and abdominal pressure was performed in 2.5 min intervals; results were captured electronically and entered in a database along with laboratory data by a blinded technician. Data analysis was performed by an investigator blinded to the procedure using t-test and repeated measures linear model. IACUC approval was obtained for the study.
Results: All procedures were successfully completed. One NOTES animal succumbed to hemorrhagic gastritis on day 3. Animals undergoing standard laparoscopy revealed increasing tachycardia compared to the NOTES group (baseline +22bpm vs baseline -10 bpm, p=0.004) and acidosis (baseline -0.1 vs baseline – 0.05, p = 0.04). Widening pulse pressure was noted in the NOTES animals compared to the laparoscopy group (p


Session: Podium Presentation

Program Number: S024

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