Purpose: The lack of high-fidelity instrumentation has impeded the development and implementation of natural orifice transluminal endoscopic surgery (NOTES). A steerable flexible trocar (SFT), a rotary access needle (RAN), and an articulating needle knife were developed as components of a flexible instrument set to facilitate transgastric peritoneal access and transluminal abdominal procedures. This cohort study aimed to assess the safety, feasibility, and efficacy of these devices during transgastric peritoneoscopy.
Methods: Ten morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass participated in the study. Following laparoscopic access, transgastric peritoneal access was established using the SFT and RAN, and transgastric peritoneoscopy performed. NOTES adhesiolysis was performed in 2 patients with significant intra-abdominal adhesions due to prior surgery. Outcome measures included time to enter the peritoneal cavity, ability to visualize each quadrant of the abdomen, ability to perform adhesiolysis, and complications.
Results: Ten patients with a median body mass index as stated in table 1 of 47.5 kg/m(2) were enrolled. Successful transgastric access was achieved in 8 of the 10 patients. One procedure was aborted because of difficulty creating the gastrotomy. Another procedure was aborted because of the difficult passage of the device through the oropharynx. An upper esophageal laceration occurred in one patient. Transgastric peritoneal access required 17.4 ± 5.5 minutes, and peritoneoscopy averaged 24.7 ± 7.6 minutes. The 4 abdominal quadrants were visualized and were accessible with the endoscope in all patients.
Conclusions: The SFT and RAN facilitate transgastric peritoneal access and visualization of difficult-to-reach areas of the peritoneum. These devices provide advanced instrumentation for transgastric NOTES procedures; however, care must be taken during the transoral insertion to avoid complications.
Keywords: NOTES; natural orifice transluminal endoscopic surgery; scarless surgery; transluminal surgery.