Broad clinical utilization of NOTES: is it safe?

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) has been the focus of several studies as a less invasive alternative to conventional laparoscopy to access and treat intracavitary organs. For the last 5 years, much has been accomplished with animal studies, yet the clinical utilization of this novel technique is still modest. After 2 years of experience in the laboratory, we started our clinical experience. We report our experience with clinical utilization of NOTES procedures from 2007 to 2010. METHODS: Under UCSD institutional review board-approved trials, 104 patients were enrolled under seven different NOTES protocols from 2007 to 2010, where a NOTES procedure was offered as an alternative to conventional treatments. The treated pathologies were cholelithiasis, biliary dyskinesia, acute and chronic appendicitis, ventral hernias, morbid obesity, and achalasia. The access routes included transgastric (TG), transvaginal (TV), transesophageal (TE), and perirectal (PR). RESULTS: Among the 104 patients enrolled, 103 underwent a surgical procedure starting with diagnostic laparoscopy, and 94 cases were deemed appropriate to proceed via a NOTES approach. There were 9 aborted NOTES procedures at the time of the initial peritoneoscopy before creating a NOTES access route. The reasons to not proceed with a NOTES procedure in the TV cholecystectomy group (n = 5) were a large amount of pelvic adhesions in 4 patients and a severe inflammation of the gallbladder in 1 patient. In the TG cholecystectomy group (n = 1), it was severe inflammation of the gallbladder. In the TG appendectomy group (n = 1), it was the presence of localized peritonitis. In the TE endoscopic myotomy group (n = 2), it was the presence of megaesophagus with an inability to clean the esophagus of food debris. The NOTES procedures performed were 48 TV cholecystectomies, 4 TV appendectomies, 8 TG cholecystectomies, 2 PR peritoneoscopies, 3 TG appendectomies, 3 TV ventral hernia repairs, 5 TE endoscopic myotomies, 3 TV sleeve gastrectomies, and 18 TG sleeve gastrectomies. The average body mass indexes for those in the sleeve gastrectomy group was 42.1 kg/m(2) (TG route) and 40.6 kg/m(2) (TV route). There were no intraoperative complication and no conversions to standard laparoscopy during these procedures. The average hospital stay was 1-2 days. One patient who underwent TV cholecystectomy required an emergency department visit for nausea and vomiting. To date, 3 patients who underwent TV cholecystectomy have become pregnant and delivered normally. CONCLUSIONS: NOTES is safe, feasible, and reproducible with previous training in the laboratory and a consistent team at a high-volume center. Prospective randomized studies of a large patient population are necessary to assess long-term results.

Transesophageal endoscopic myotomy (TEEM) for the treatment of achalasia: the United States human experience.

BACKGROUND: From our early experience with NOTES, our group has acquired familiarity with transesophageal submucosal dissection and myotomy in swine model, which allowed us to perfect a model to perform purely endoscopic transesophageal myotomy (TEEM) for the treatment of achalasia and apply it into clinical practice. This study was designed to assess the safety, feasibility, and efficacy of TEEM in a series of patients with achalasia. METHODS: Under institutional review board approval, patients were enrolled on our study, where TEEM was offered as an alternative to laparoscopic or robotic Heller myotomy. The inclusion criteria were patients with achalasia confirmed by esophageal manometry, between age 18 and 50 years, and ASA class 2 or lower. The exclusion criteria were pregnancy, prior esophageal surgery, immunosuppression, coagulopathies, and severe medical comorbidities. The procedures were performed under general anesthesia, with the patient in supine position on positive pressure ventilation. With a GIF-180 (Olympus, Tokyo, Japan) positioned at 10 cm above the GEJ, a mucosotomy was performed at the 2 o'clock position, and a submucosal space was developed caudally creating a controlled submucosal tunnel extending 2 cm distal to the GEJ. Upon completion of this tunnel the gastroesophageal lumen was inspected for mucosal integrity. The scope was then reinserted into the submucosal tunnel and using a triangle-tip knife, myotomy was performed starting at 5 cm above the GEJ and ending at 2 cm below the GEJ. During this process the circular muscle layer of the esophagus was carefully divided with preservation of the longitudinal layer. At the end of the procedure, the mucosal incision was closed longitudinally with endoscopic clips and surgical glue. RESULTS: Five patients underwent TEEM, with no perioperative complication. All patients reported significant improvement of their dysphagia immediately after the procedure. On the first postoperative day, all barium swallows showed disappearance of the classical bird beak taper, rapid emptying of contrast into the stomach, and absence of leaks. All patients were discharged on the second postoperative day on liquid diet. Two patients reported transient heartburn, which were well controlled with medications. The average preoperative GERD-HRQL was 20, which improved to 11.3 at 7 days postoperative and 2 at 30 days postoperative. To date, three patients have already returned for their 6-month follow-up, reporting adequate swallowing and low LES pressures on esophageal manometry (their mean preoperative LES resting pressure was 36.46 mmHg and residual pressure was 43.16 mmHg, whereas the 6-month follow-up mean LES resting pressure was 10.06 mmHg and residual pressure was 0.43 mmHg). CONCLUSIONS: TEEM seems to be safe, feasible, and effective for the treatment of patients with achalasia. Long-term data are still necessary for wide-spread utilization of this novel technique.

Transgastric large-organ extraction: the initial human experience.

INTRODUCTION: In laparoscopy, it often is the case that port sites are enlarged for specimen extraction. This leads to higher risk of trocar site complications, such as infection or incisional hernia. Natural orifice surgery (NOTES) is beneficial for minimizing these complications, and this is emphasized when the extracted specimen is of large volume. We have been using transgastric technique for appendectomy, cholecystectomy, and laparoscopic sleeve gastrectomy (LSG). Of these transgastric operations, we focus on the one with relatively large-organ extraction: LSG with transoral remnant extraction (TORE). We describe the details and feasibility of this procedure and compare the outcomes to conventional LSG. METHODS: All patients undergoing LSG were considered candidates for TORE and were consented for this procedure if interested after an informed discussion. Eighteen LSGs with TORE (TORE group) and ten conventional LSGs (non-TORE group) were performed from August 2010 to March 2011. We retrospectively compared these two groups for the age, sex, preoperative body mass index, operating room time, hospital stay, excess weight loss (EWL), and trocar site complications. Laparoscopic sleeve gastrectomy with TORE consists of conventional LSG and transgastric retrieval of the resected stomach. The procedure exceeds exactly the same manner as conventional LSG until the initial stapling of the stomach. For TORE, the gastrectomy is initiated 5 cm proximal to the pylorus than usual LSG to save the space for the gastrotomy used for specimen retrieval. After the gastrectomy is completed, the full thickness of the distal most part of the staple line is incised open as wide as 2 cm by using electric cautery or ultrasonic dissector. A flexible upper endoscope, which has been in the stomach already as a bougie for gastrectomy, is then guided into the peritoneal cavity through the gastrotomy. The specimen is grasped endoscopically with a snare and extracted transorally. Following this, the gastrotomy is closed laparoscopically. The final shape of the gastric sleeve is identical to the one of conventional LSG. RESULTS: There was no significant difference between the TORE and the non-TORE group for patients' profile, operating room time, hospital stay, and EWL. Neither group has experienced perioperative complications. All specimens were extracted readily and safely in the TORE group. Of the ten cases in the non-TORE group, four required extension of the trocar site. No trocar site complications were found in the TORE group, whereas the extended trocar site developed panniculitis in two cases of the non-TORE group; one required panniculectomy for refractory induration. CONCLUSIONS: TORE can be safely and easily performed by surgeons with laparoscopic and endoscopic skill, and with commonly available instruments. While producing identical outcomes, our initial experience with the TORE technique demonstrates an advantage over traditional LSG, because it minimizes trocar site complications. Transgastric organ extraction is potentially applicable to other large-organ extractions in laparoscopic surgery without excessive risk or resources. Larger case volume and longer follow-up period is awaited.

Feasibility of transrectal hybrid natural orifice transluminal endoscopic surgery (NOTES) nephrectomy in the cadaveric model.

OBJECTIVE: To examine feasibility of transrectal hybrid natural orifice transluminal endoscopic surgery (NOTES) nephrectomy in human cadavers in the evolution of this technique, as transrectal hybrid NOTES nephrectomy has been demonstrated in the porcine model. METHODS: Four hybrid transrectal NOTES nephrectomies were performed on 4 cadavers (3 female/1 male, 2 right/2 left). Pneumoperitoneum was created by periumbilical 12-mm trocar, through which a laparoscope was advanced to obtain intra-abdominal visualization. A 4-cm horizontal incision was made 2-cm above the dentate line and a submucosal tunnel was created in the posterior rectal wall/presacral space. A dual-channel gastroscope was advanced through the submucosal tunnel and retroperitoneum to the level of the kidney using air insufflation. A peritoneal window was created and renal mobilization was completed. A transumbilically applied laparoscopic 45-mm stapler was used to transect the ureter and renal hilum. A specimen entrapment bag was deployed transrectally for specimen extraction, followed by transrectal incision closure. RESULTS: Transrectal NOTES nephrectomy was successfully performed in all cases, with intact specimen extraction. Median weight was 77 kg (range 74-85 kg); median body mass index (BMI) was 30.1 kg/m(2) (range 25.6-31.2 kg/m(2)). Mean operative time was 175 minutes (range 150-210 minutes). Median transrectal access time was 36 minutes (range 24-47 minutes). Median dimensions of removed kidneys were length 11.2 cm (range 10-12 cm), width 5 cm (range 4.5-6 cm), and thickness 3.8 cm (range 3-4.5 cm). CONCLUSION: Transrectal hybrid NOTES nephrectomy in the cadaver model is feasible with intact specimen extraction and acceptable operative times. Preclinical survival studies are requisite to assess sterility and complications. This approach may be an alternative to transvaginal access.